Edc Jobs in Usa

28 positions found

Senior Director, Clinical Data Standards
✦ New
Salary not disclosed
Boston, Massachusetts 12 hours ago

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Director, Clinical Data Standards based remotely reporting to the Vice President, Clinical Data Operations & Standards.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

  • In collaboration with the Clinical Data Strategy & Operations Leaders, and TAU Leaders, and other functional area leadership to develop, establishes and drives strategy of Takeda's global data standards, processes and technologies across the clinical data continuum for quality of deliverables and global data interoperability.
  • Responsible for establishing and managing a Standards vendor to support Standards Management vision.
  • Responsible for end-to-end Standards Governance to ensure proper utilization, adherence to standards governance and processes, and the ongoing, thorough assessment of library enhancements and deviations.
  • Build relationships across the global Takeda organization and with vendor partners in support of the standards vision and implementation.
  • Participates with and influences at industry standards forums in support of Takeda's therapeutic areas.
  • Serves as a resource to support questions raised by regulatory agencies.

ACCOUNTABILITIES:

  • Has advanced knowledge of all standard library components and metadata across data collection, analysis and reporting continuum.
  • Works with Clinical Data Strategy & Operations Leaders, TAU Leaders, and other functional area leadership to develop, and adhere to, Standards Management vision and overall metadata management strategy.
  • Leads cross-functional Standards initiatives internal or external to Takeda and helps to ensure coherence of standards initiatives across organization.
  • Provides strategic guidance toward execution of comprehensive data continuum to staff and vendors acting as project managers or leads on cross-functional initiatives.
  • Supervises staff and vendors developing standards library to ensure alignment to standards strategy.
  • Develops training strategy and ensures consistent training program for standards.
  • Provides senior oversight to vendor/CROs for utilization of Takeda standards.
  • Conducts ongoing review and development of metrics to assess standards utilization and development trends.
  • Oversees Standards Governance, managing deviations from standards content and processes.
  • Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, SCDM, EDC users group, SAS users group, Third Party Data Acquisition groups, etc.
  • Actively communicates submission standards and guidance documents, regulatory agency expectations and industry trends to Takeda organization.
  • Complies with all applicable regulatory expectations.

EDUCATION AND EXPERIENCE:

  • BS/BA or MS in a life science or analytical area.
  • 12 years data management and/or database or statistical programming experience in pharmaceutical industry or health related field.
  • 8+ years of experience supporting clinical trials across all phases of development.
  • 5+ years of progressive management experience.
  • Proven track record for development and management of a standards library.
  • In-depth knowledge of data management systems and processes, analysis and reporting principles.
  • Good knowledge of statistical programming languages (e.g. SAS).
  • Technical expertise (e.g. Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS.
  • Expertise in the requirements and technology required to support electronic data capture and electronic submissions.
  • Proven track record in identifying and implementing organization-wide initiatives, standards, and processes.
  • Proven track record in managing global, cross-functional standards and processes.
  • Knowledge of medical and statistical terminology. Comprehensive understanding of pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH and ODM), HL7, etc.)
  • Able to influence without authority.
  • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
  • Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo.
  • Pragmatic and willing to drive and support change.
  • Is comfortable with ambiguity .
  • Support a culture of continual improvement and innovation; promote knowledge sharing.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$208,200.00 - $327,140.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

#LI-Remote

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Clinical Research Coordinator - Accellacare (Salisbury, NC)
✦ New
Salary not disclosed
Salisbury, NC 1 day ago

Clinical Research Coordinator


ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development


This role is with Accellacare, part of ICON's clinical research network, where you’ll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research.


Title: Clinical Research Coordinator

Location: 410 Mocksville Avenue, Salisbury, North Carolina 28144 USA


Summary: The CRC ensures the safety of our participants, promotes the mission of Accellacare, and consistently strides to meet and exceed priorities discussed with supervisor. The CRC will actively recruit and promote our service to suitable participants and sponsor representatives. Additionally, the CRC 1 will autonomously perform tasks required to coordinate and complete multiple studies according to the protocol. Lastly, they will assist the Manager of Clinical Operations and Sr. Clinical Research Coordinators with staff development through mentoring and site level quality assurance.


Duties:

β€’ Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site

β€’ Proactively develops and executes recruitment plans that meet and exceed enrollment goals

β€’ Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.

β€’ Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.

β€’ Attends investigator meetings

β€’ Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines

β€’ Accurately collects study data via source documents/progress notes as required by the protocol

β€’ Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol

β€’ Performs continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials

β€’ Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events

β€’ Builds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants

β€’ Dispenses study medication at the direction of the Investigator

β€’ Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits

β€’ Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor


To be successful, you will have:

β€’ Bachelor's Degree

β€’ 1 + years of experience as a clinical research coordinator or equivalent role

β€’ High attention to detail

β€’ Interest in a clinical research career

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Data Scientist
✦ New
🏒 Harnham
Salary not disclosed
San Francisco, CA 1 day ago

Clinical Data Scientist

Redwood City, CA (Hybrid potentially remote options)

Salary: $150,000-$190,000


No Sponsorship Available



About the Role


We are seeking a Clinical Data Scientist to play a pivotal role in transforming complex clinical datasets into high‑quality, analysis‑ready outputs used to support clinical trials and real‑world evidence initiatives.


In this role, you will operate at the intersection of data science, clinical research, and statistical programming. You’ll be responsible for validating, cleaning, and structuring data originating from multiple sourcesβ€”including expert manual abstraction teams, AI‑assisted pipelines, EMR feeds, and EDC systems.


You’ll collaborate closely with Clinical Operations, Data Engineering, and AI/ML teams to ensure accuracy, traceability, and compliance across every dataset delivered internally or externally.

This role is ideal for someone who is detail‑obsessed, technically versatile, and passionate about elevating the quality of clinical data used in drug development.


What You’ll Do

  • Convert raw, manually abstracted, and AI‑processed datasets into standardized formats (e.g., CDISC SDTM/ADaM) or client‑specific data models.
  • Ensure outputs meet quality, compliance, and traceability standards.
  • Generate TLFs (Tables, Listings, Figures) for clinical reports and interim analyses using SAS, R, or Python.
  • Perform robust data cleaning and QC checks.
  • Investigate anomalies and troubleshoot issues across the data pipeline.
  • Distinguish between upstream extraction issues and true clinical variations.
  • Partner with Data Platform and AI teams to automate cleaning scripts, validations, and workflow logic.
  • Serve as an early user and feedback partner for internal data tools.
  • Maintain documentation for data derivations, specifications, and validation logic (e.g., Define.xml, Reviewers Guides).
  • Support compliance and regulatory submission needs.
  • Complete internal and external analysis requests to support clinical insights, client value, and platform performance.
  • Apply HIPAA-aligned data safeguards and adhere to best practices across privacy, security, and data governance.


What You Bring

  • Education:
  • BSc/MSc in Statistics, Mathematics, Computer Science, Life Sciences, or related field.
  • Experience:
  • 2–5+ years in clinical data science, statistical programming, or data management in pharma/biotech.
  • Technical Strengths:
  • SAS, R, Python, SQL
  • Experience with Git/version control preferred
  • Industry Knowledge:
  • Familiarity with clinical trial workflows
  • Strong understanding of CDISC SDTM/ADaM
  • Oncology endpoints (RECIST, survival) and RWD experience is a plus
  • Data Wrangling:
  • Comfort β€œstitching together” messy, real‑world clinical datasets
  • Experience with unstructured text or NLP outputs is desirable
  • Soft Skills:
  • Exceptional attention to detail
  • Clear, structured communicator
  • Proactive, self‑directed, collaborative
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Site Research Assistant
✦ New
🏒 IQVIA
Salary not disclosed
Merrillville, IN 1 day ago

Site Research Assistant – Merrillville, IN

Work Setup: On-site

Scheduled Hours: 40 hours per week


About IQVIA

IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services, dedicated to driving healthcare forward. We partner with the world’s leading pharmaceutical, biotechnology, and medical device companies to improve patient outcomes and accelerate innovation. Our team combines deep scientific expertise with cutting-edge technology to deliver high-quality data and insights that shape the future of clinical trials.


Job Summary

The Research Assistant plays a critical role in supporting clinical trial activities in accordance with GCP, IRB, and all applicable regulatory requirements. This position requires strong attention to detail, the ability to prioritize in a fast‑paced environment, and excellent communication skills. Experience in cardiovascular studies and hands‑on familiarity with EDC entry, query resolution, prescreening referrals, reviewing charts from site databases, and related clinical research tasks are highly valued.


Key Responsibilities

  • Perform EDC data entry and query resolution in a timely and accurate manner.
  • Review patient charts and records from the site database to support protocol‑required tasks.
  • Build and maintain strong working relationships with investigators, clinical staff, and study teams.
  • Assist in screening, prescreening referrals, recruiting, and enrolling research participants.
  • Manage scheduling of participants, visit scheduling, reminders, and protocol‑related procedures.
  • Collect participant history and coordinate laboratory requirements and follow‑up care.
  • Support the informed consent process, ensuring adherence to IRB‑approved protocols.
  • Promote participant safety by following protocol guidelines and reporting requirements.
  • Ensure compliance with Sponsor and company SOPs, policies, and regulatory guidelines.
  • Maintain study supplies and support upkeep of the regulatory binder.
  • Record (but not obtain) vital signs as required by study protocol.


Qualifications

  • Minimum of an associate’s degree or equivalent education and experience.
  • At least 1 year of experience in a clinical research setting (preferred).
  • Working knowledge of clinical trials, GCP principles, and study‑specific procedures.
  • Familiarity with cardiovascular studies (preferred).
  • Demonstrated experience with:
  • Reviewing charts from site databases
  • Prescreening referrals
  • EDC entry and query resolution
  • Visit scheduling and reminders
  • Maintaining study supplies
  • Upkeep of regulatory binders
  • Recording (not obtaining) vital signs
  • Ability to perform required clinical procedures and understand medical terminology.
  • High attention to detail and strong organizational skills.
  • Ability to collaborate effectively with coworkers, physicians, patients, and study stakeholders.
  • Certifications and licenses as required by company, state, country, or regulatory bodies.


Note: This position is not eligible for sponsorship.

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Licensed Practical Nurse
✦ New
🏒 Mindlance
Salary not disclosed
Bowie, MD 1 day ago

Job Details:


Job: Licensed Practical Nurse

Duration : 5-6 Months (Possibility of extension)

Location: Onsite - Bowie, MD 20715

Shift: Mon to Fri - Standard Hours


Study coordinator to support ongoing large clinical study in US. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry and query resolution.


Essential Functions:

β€’ Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.

β€’ Provides medical care to patients, always ensuring patient safety comes first.

β€’ Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.

β€’ Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).

β€’ Records all patient information and results from tests as per protocol on required forms.

β€’ Where required, may complete IP accountability logs and associated information.

β€’ Reports suspected non-compliance to relevant site staff.

β€’ Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.

β€’ Promotes the company and builds a positive relationship with patients to ensure retention.

β€’ Attends site initiation meetings and all other relevant meetings to receive training on protocol.

β€’ May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.

β€’ Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.

β€’ Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.

β€’ Adheres to company COP/SCOP.

β€’ May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.


Education and Experience:

β€’ Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field.

β€’ Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority.

β€’ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).


Knowledge, Skills and Abilities:

β€’ Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.).

β€’ Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving.

β€’ Demonstrated ability to exercise discretion and sound judgement.

β€’ Good decision-making, negotiation and influencing skills.

β€’ Good communication skills and English fluency will be an advantage.

β€’ Good organizational skills.

β€’ Good proficiency in basic computer applications.

β€’ Good interpersonal skills to work in a team environment.


EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.


Thanks in advance for your time and consideration; please feel free to provide a current version of your resume. I look forward to hearing from you!

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Senior Clinical Research Coordinator - Accellacare (Cary, NC)
✦ New
🏒 ICON Strategic Solutions
Salary not disclosed
Cary, NC 1 day ago

Sr Clinical Research Coordinator - Cary, NC


ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development


This role is with Accellacare, part of ICON's clinical research network, where you’ll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research.


Title: Sr Clinical Research Coordinator (Sr CRC)

Location: On-Site Cary, NC - 530 New Waverly Place, Suite 200A, Cary, NC 27518 USA


The Sr CRC ensures the safety of our participants, promotes the mission of Accellacare, and consistently strides to meet and exceed priorities discussed with supervisor. The Sr CRC will actively recruit and promote our service to suitable participants and sponsor representatives. Additionally, the Sr CRC will autonomously perform tasks required to coordinate and complete multiple studies according to the protocol. Lastly, they will assist the Manager of Clinical Operations and Sr. Clinical Research Coordinators with staff development through mentoring and site level quality assurance.


Duties:

  • Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site
  • Proactively develops and executes recruitment plans that meet and exceed enrollment goals
  • Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
  • Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
  • Attends investigator meetings
  • Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines
  • Accurately collects study data via source documents/progress notes as required by the protocol
  • Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol
  • Performs continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials
  • Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events
  • Builds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants
  • Dispenses study medication at the direction of the Investigator
  • Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits
  • Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor


To be successful, you will have:

  • Bachelor's Degree
  • 3 + years of experience as a clinical research coordinator or equivalent role
  • High attention to detail
  • Interest in a clinical research career
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Clinical Data Manager
✦ New
Salary not disclosed
New York, NY 1 day ago
Senior Clinical Data Manager

Location: 1 Day a week onsite in NYC

Salary: $140-160k Base plus bonus

Scientific Search has partnered with a clinical-stage pharmaceutical company pioneering novel approaches to treating cancer. The Senior Clinical Data Manager brings hands-on experience in oncology clinical data management, deep familiarity with Medidata Rave and the ability to work cross-functionally in a fast-paced biotech environment.

Responsibilities

  • Own and manage clinical data management activities for assigned early-phase oncology studies, ensuring data quality, integrity, and inspection readiness.
  • Serve as the primary owner and administrator of the company’s Medidata platform, including Cloud Admin configuration and maintenance, user access management, etc.
  • Provide oversight of EDC builds and updates, including review and approval of database specifications and edit check specifications, completion of UAT, etc.
  • Develop and implement data review plans and coordinate ongoing external and internal data cleaning and query management activities.
  • Review data listings to support study oversight and decision-making.
  • Collaborate cross-functionally with Clinical Operations, Clinical Science, Biostatistics, Medical, and external vendors/CROs to ensure alignment and timely data delivery.
  • Monitor data management metrics and reports to ensure compliance with protocols and study plans.
  • Contribute to process improvement, SOP development, and inspection readiness activities as the clinical organization continues to scale.

Requirements

  • Bachelor’s degree in life sciences, data science, or a related field.
  • 6+ years of clinical data management experience, with at least 3 years in oncology clinical trials.
  • Prior experience in early-phase (Phase 1/1b/2) oncology trials within a biotech or CRO setting.
  • Extensive hands-on experience with Medidata including Cloud Admin and Rave EDC.
  • Elluminate administration experience a plus
  • Strong understanding of CDISC standards.
  • Experience working with CROs and vendors, including oversight of outsourced data management activities.
  • Working knowledge of GCP, ICH, and regulatory expectations for clinical data.
  • Highly detail-oriented with strong organizational and problem-solving skills.
  • Adaptable mindset with interest in helping build and scale data management capabilities.

How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to and tell me why you’re interested. Or, feel free to email your resume.

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Attorney
🏒 Primis
Salary not disclosed

Job Title: Attorney – Social Security Disability (SSDI)

Location: Remote

Contract: 3–6 Month Contract

About the Role

We are seeking an experienced Attorney with a strong background in Social Security Disability Insurance (SSDI) to support a high-volume disability practice. This fully remote, 3–6 month contract is ideal for an attorney who is confident managing disability cases, preparing clients for hearings, and advocating before Administrative Law Judges.

Key Responsibilities

  • Manage SSDI and SSI disability cases from initial review through hearing preparation
  • Represent clients in Administrative Law Judge (ALJ) hearings
  • Review medical records and develop legal strategies to support disability claims
  • Prepare legal briefs, appeals, and case summaries
  • Provide guidance to paralegals and support staff on case preparation
  • Communicate directly with clients, medical providers, and the Social Security Administration (SSA)
  • Ensure all filings and documentation comply with SSA regulations and deadlines
  • Evaluate new claims and determine eligibility for representation

Required Experience

  • Active U.S. Bar license
  • 2+ years experience handling SSDI/SSI disability cases
  • Experience representing clients in ALJ hearings
  • Strong understanding of Social Security disability law and SSA procedures
  • Ability to manage a high-volume caseload

Skills & Qualifications

  • Strong advocacy and legal writing skills
  • Excellent client communication and case management abilities
  • High attention to detail and ability to meet strict deadlines
  • Ability to work independently in a remote environment
  • Proficiency with legal case management systems and document review tools

Preferred

  • Experience working in a disability law firm or SSDI-focused practice
  • Familiarity with SSA electronic systems (EDCS / eView)
  • Experience with appeals and federal court disability cases

Disclaimer: Research indicates that men will apply to a role when they only meet 50-60% of the descriptions, however, when looking at women and other minority groups, they can look for up to a 99% match in order to apply to a role. If you feel you are a fit for our role, please still apply, don't worry if you don't tick every single box. We'd still love to hear from you. We encourage underrepresented talent to apply to all our roles & support accessibility needs

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Physician Assistant - Clinical Research (Sub-Investigator)
Salary not disclosed
Brooklyn, NY 5 days ago

Physician Assistant – Clinical Research (Sub-Investigator)

Location: Brooklyn, NY


About Brooklyn Clinical Research:

Brooklyn Clinical Research was founded to increase access to clinical trials for underrepresented populations. Clinical-trial enrollment should accurately represent the broader population. In meeting this objective, we help improve therapeutic efficacy and safety for all individuals.


Position Overview:

We are seeking a clinically adept, highly motivated Physician Assistant to join our growing research team as a Sub-Investigator. This is a hands-on clinical research role, working alongside our full-time Principal Investigator (MD) to conduct industry-sponsored clinical trials.


The ideal candidate will thrive in a fast-paced, dynamic environment where flexibility, strong clinical decision-making, and attention to detail are essential. You will receive full training in clinical research and GCP, and you will play a key role in the daily conduct of clinical trials β€” performing protocol-specific assessments, managing study visits, and ensuring participant safety and regulatory compliance.


Key Responsibilities:

  • Serve as a Sub-Investigator on assigned clinical trials under supervision of the Principal Investigator.
  • Perform protocol-required medical evaluations, including detailed histories, physical exams, safety assessments, and medical oversight of study participants.
  • Administer investigational products (e.g., vaccines, injectables) according to protocol.
  • Perform and oversee clinical procedures including phlebotomy, vital signs, ECGs, and other protocol-specified tests.
  • Assess and document adverse events and serious adverse events according to FDA and Sponsor guidelines.
  • Maintain thorough, timely, and accurate source documentation and electronic data entry (EDC, eSource, CTMS).
  • Collaborate closely with clinical coordinators, regulatory staff, sponsors, and CROs.
  • Participate in monitoring visits, audits, and inspections.
  • Maintain comprehensive knowledge of study protocols, informed consent documents, and regulatory requirements.
  • Participate actively in team meetings, contributing to ongoing process improvement as our site grows.
  • Act as a supplementary Clinical Research Coordinator on an as-needed basis.


Qualifications:

  • Graduate of an accredited Physician Assistant program (required).
  • Active Physician Assistant license in New York State (required).
  • Prior clinical research experience is a strong plus but not required.
  • Extensive background in direct patient care.
  • Current BLS/CPR certification.


Key Attributes for Success:

  • Excited to work in a fast-paced clinical environment where protocols and patient needs can vary daily.
  • Strong clinical acumen and independent judgment.
  • Detail-oriented with excellent documentation skills.
  • Highly organized with the ability to manage multiple protocols simultaneously.
  • Excellent communication and teamwork skills.
  • Commitment to patient safety, protocol adherence, and research integrity.
  • Spanish fluency or medical Spanish is a plus but not required.


Position Details:

  • Full-time, salaried position, Monday–Friday. Occasional weekend work may be required during high-volume vaccine periods.
  • Anticipated Start Date: ASAP
  • Salary Range: $140,000 to $170,000 depending on experience.


Why Join Us:

This is an excellent opportunity for a PA who is interested in advancing their career into clinical research while maintaining direct patient interaction. You will be a key member of a high-performing, mission-driven team with meaningful opportunities for professional growth as our research site expands.


Notice to Recruiters and Agencies

We do not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please do not forward resumes to our employees or any company location/contact. Brooklyn Clinical Research is not responsible for any fees related to unsolicited resumes. We will consider any CV or resume received without a prior, signed agreement to be the property of Brooklyn Clinical Research, and we will process it accordingly without fee or obligation.

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Project Estimator
🏒 EDC
Salary not disclosed
Midlothian, VA 5 days ago

ABOUT EDC

EDC is one of the most respected construction companies in the country, with a geographic reach that covers the entire Eastern United States. EDC’s diverse expertise in project types includes retail, entertainment, multifamily, self-storage, sports and recreation, and industrial. Since 1990, we've been building not just structures, but also a strong community of skilled professionals. At EDC, we are more than 60 people strong, with over 30 employees who have ownership stakes in the firm.


The Opportunity

EDC is seeking a Project Estimator to work closely with Project Managers to ensure projects are priced competitively, include qualified subcontractors, and meet the client’s time and budget constraints. Early involvement of Estimators in project planning is critical to the overall success of our projects. We may require occasional travel.


What You’ll Do

  • Work closely with the Project Managers during the preconstruction phase.
  • Conduct scope of work evaluations, bid preparation, take-offs, and risk assessment on each job.
  • Establish and maintain working relationships with vendors, subcontractors, and clients.
  • Responsible for conceptual, schematic, design development estimates, GMPs, and lump sum bids.
  • Formulate advice upon reviewing all aspects of a project and participate in meetings with the owner, architect, and engineer to discuss your advice.
  • Lead preconstruction review meetings.
  • Plan and establish appropriate quality assurance/quality control processes into project models.
  • Perform other duties as necessary or assigned.


What We Expect from You

  • Bachelor’s degree in construction, architecture, or civil engineering, or 5+ years of relevant experience working in industrial, entertainment, retail, self-storage, and/or multi-family construction.
  • Strong computer skills and knowledge of Microsoft Word, Excel, Project, Revu, Bluebeam, or similar platforms.
  • Self-motivated, able to analyze problems and strategize for best solutions.
  • Excellent ability to communicate, multi-task, and meet strict deadlines.
  • Must have permanent authorization to work in the US.


WHAT YOU CAN EXPECT FROM EDC

We offer our Project Estimators competitive pay. Our benefits package includes:

  • Employer-paid medical
  • Employer-paid dental
  • Life insurance
  • Short and long-term disability
  • 401(K) employer match
  • Potential for ownership after five years
  • Paid health club memberships
  • Flexible work hours
  • Generous paid time off
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Registered Dietitian - 250656
🏒 Medixβ„’
Salary not disclosed
Houston, TX 6 days ago

Now Hiring: Bilingual Registered Dietitian (Spanish-Speaking) | Houston, TX


We are seeking a Licensed or Certified Dietitian to join a growing clinical research team in Houston. This is an excellent opportunity for a dietitian who is passionate about patient care, nutrition counseling, and contributing to innovative research that improves health outcomes.

This role will flex between two Houston locations (Rothway – Northwest Houston and Bellaire) and offers a consistent weekday schedule.


Schedule: Monday–Friday, 7:00 AM–3:00 PM or 8:00 AM–4:00 PM (based on patient schedule)


Salary: $60,000–$70,000 annually


Location: Houston, TX (Rothway & Bellaire sites)


Language Requirement: Spanish and English (required)


Key Responsibilities

β€’ Conduct comprehensive nutritional assessments and evaluate participant eligibility based on protocol requirements

β€’ Provide nutrition counseling and health coaching, including weight management and healthy lifestyle guidance

β€’ Complete source documentation and enter accurate data into Electronic Data Capture (EDC) systems such as Medidata Rave or TrialKit

β€’ Ensure compliance with study protocols, sponsor requirements, and regulatory standards

β€’ Record adverse events and maintain communication with sponsors and contract research organizations (CROs)

β€’ Educate participants on study requirements and support adherence throughout the clinical trial process

β€’ Assist with audit preparation and ongoing quality assurance activities


Required Qualifications

β€’ Degree in Nutrition from an accredited institution

β€’ Licensed or Certified Dietitian eligible to be listed on the FDA 1572 regulatory form

β€’ Fluency in Spanish and English (speaking, reading, and writing)

β€’ Strong documentation, communication, and patient education skills


Preferred Qualifications

β€’ Experience in a clinical or hospital setting, especially working with chronic conditions

β€’ Interest in or exposure to clinical research (training provided for candidates new to research)

β€’ Proficiency with Microsoft Office Suite and electronic documentation systems

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Clinical Research Coordinator II
Salary not disclosed
Moline 1 week ago
Job Title: Clinical Research Coordinator II Location: Moline, IL Duration: 6 Months+ (Possible Extension) Shift: Monday – Friday (8 am – 5 pm) Pay rate: $22
- $29/hr.

on W2.

Job Description: Summarized Purpose: Study coordinator to support ongoing large clinical study in US.

Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process.

Interacts with the research site team and other interdepartmental staff.

Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry and query resolution.

Essential Functions: Β· Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.

Β· Provides medical care to patients, always ensuring patient safety comes first.

Β· Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.

Β· Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).

Β· Records all patient information and results from tests as per protocol on required forms.

Β· Where required, may complete IP accountability logs and associated information.

Β· Reports suspected non-compliance to relevant site staff.

Β· Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.

Β· Promotes the company and builds a positive relationship with patients to ensure retention.

Β· Attends site initiation meetings and all other relevant meetings to receive training on protocol.

Β· May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.

Β· Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.

Β· Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.

Β· Adheres to company COP/SCOP.

Β· May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.

Education and Experience: Β· Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field Β· Must hold a valid nursing license (RN, LVN, LPN) within the country operating.

Must be registered with local health care authority.

Β· Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).

Knowledge, Skills, and Abilities: Β· Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.) Β· Capable of working independently, analyzing, and working with attention to detail, processing and prioritizing sensitive complex information and problem solving Β· Demonstrated ability to exercise discretion and sound judgement Β· Good decision-making, negotiation and influencing skills Β· Good communication skills and English fluency will be an advantage Β· Good organizational skills Β· Good proficiency in basic computer applications Β· Good interpersonal skills to work in a team environment.
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General Manager
Salary not disclosed
Seattle, WA 1 week ago

Job Description


Purpose of the Position

Promote the values and culture of our organization through professional leadership of your employees. This is an exempt position that reports directly to the Regional Operations Manager and indirectly to others in corporate management.

Energy - The General Manager will champion the needs of others through Passion, Integrity, and Initiative to drive the company culture in all that we do.

Discovery - The General Manager will drive growth within their restaurant through development, training, and fiscal responsibility.

Community - The General Manager will be a brand ambassador in the mission and values of Eureka! through grassroots marketing, talent acquisition, and passion to serve our community.


THE PERKS!:

  • Competitive Salary: 85-100k depending on experience
  • Quarterly Bonus Incentive
  • Fun & Fast Paced Environment
  • Company contests that include experiential trips to exciting beverage and food destinations.
  • Growth Opportunities - We promote 65% from within
  • Management Development
  • Benefits that include access to medical, dental and vision coverage (Full Time)
  • Employee Assistance Program - focusing on mental health providing licensed counseling, community support and much more

Physical Demands & Work Environment:

  • Position requires prolonged standing, bending, stooping, twisting, lifting products and supplies, and repetitive hand and wrist motion.
  • Requires working with and around hot, cold, and hazardous equipment in a fast-paced and congested environment, which may occasionally be loud, hot, cold, and/or physically demanding.
  • Occasional travel may be required, consisting of driving and/or flights for a period of one or more days, including overnight stays. Notice of travel may be given with very short notice.
  • Occasional training may take place on or off-site, by phone, or online.


Location(s)

2614 NE 46th St, Seattle, Washington 98105, United States


Requirements

Position Requirements

  • Displays a strong example and passion for our culture on every shift – EDC!
  • Must complete Management Program in Success Factors
  • At least 21 years of age
  • Food Manager certified
  • TIPs Certified
  • Minimum 4 years management experience in high-volume restaurant
  • Human Resources: Recruit, train, coach, counsel, and discipline employees; communicate job expectations; monitor, appraise, and review job contributions; enforce policies and procedures.
  • Strategic restaurant operations: Contribute accurate information and thoughtful recommendations to the company’s strategic plan through daily dialog and at formal reviews with colleagues and superiors; prepare and complete action plans; implement production, productivity, quality, and customer-service standards; resolve problems; complete audits; identify trends; determine system improvements; implement change.
  • Financial operations: Achieve restaurant financial objectives by forecasting requirements, preparing an annual budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
  • Cost control: Review portion control and quantities of food preparation; minimize food, paper (non-food goods) and labor waste; execute accurate inventories on a regular basis.
  • Litigation control: Avoid legal challenges by conforming to Alcoholic Beverage Commission (ABC) regulations; federal, state, county and city codes, laws and regulations; and landlord lease requirements.
  • Bar operations: Maximize bar profitability by ensuring portion control and monitoring accuracy of charges.
  • Safety/Sanitary standards: Maintain a safe, secure, and healthy environment by establishing, following, and enforcing sanitation standards and procedures; comply with all safety/sanitary legal regulations; develop and implement disaster plans; maintain security and sprinkler systems; maintain parking lot, walkways and exits.
  • Ambiance control: Maintain restaurant ambiance by controlling restaurant lights, light dimmers, background music, linen service, glassware, dinnerware, and utensil quality and placement; monitoring food presentation and service.
  • Continuing education: Update job knowledge by participating in educational opportunities, reading professional publications, maintaining professional networks, and participating in professional organizations.
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Clinical Research Coordinator 182825
🏒 Medixβ„’
Salary not disclosed
Media, PA 1 week ago
  • Study Operations: Coordinate and manage all aspects of clinical trials from start-up to close-out.
  • Participant Management: Recruit, screen, and enroll study participants; conduct informed consent processes.
  • Clinical Procedures: Perform study-specific procedures, such as obtaining vital signs, conducting ECGs, and collecting/processing lab specimens.
  • Data Management: Collect, document, and enter study data into Electronic Data Capture (EDC) systems accurately and in a timely manner.
  • Regulatory Compliance: Maintain regulatory binders, ensure protocol adherence, and report adverse events to the Institutional Review Board (IRB) and sponsors.
  • Liaison Duties: Act as the primary point of contact for study participants, Principal Investigators (PIs), and sponsors.
Not Specified
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Clinical Research Assistant
🏒 Denali Health
Salary not disclosed
Atlanta, Georgia 1 week ago
About Denali Health

Denali Health is a premier clinical research network dedicated to advancing medical science through high-quality clinical trials. Our Atlanta site is a hub of innovation, conducting studies that bring new therapies to patients who need them most.

We believe in investing in potential. We recognize that Certified Nursing Assistants (CNAs), Medical Assistants (MAs), and Foreign Medical Graduates (FMGs) possess the critical medical knowledge and patient care skills necessary to excel in research. At Denali, we provide the training and mentorship to turn your clinical background into a thriving career in the pharmaceutical and research industry.

The Opportunity

Are you a medical professional looking for more than just a job? Do you want to move away from standard bedside care and into the cutting-edge world of drug development?

As a Research Assistant (RA), you will work side-by-side with our Clinical Research Coordinators (CRCs) and Investigators. You will be the "hands and eyes" of our studies, managing patient visits, processing lab samples, and ensuring data accuracy. This role is designed as a career acceleratorβ€”our goal is to train you to eventually become a Clinical Research Coordinator.

Key Responsibilities
  • Patient Care & Procedures: Perform clinical tasks such as phlebotomy (blood draws), obtaining vital signs, ECGs, and height/weight measurements for study participants.
  • Data Integrity: Assist in collecting and entering source data into Electronic Data Capture (EDC) systems with high accuracy.
  • Lab Management: Process biological specimens (centrifuging, pipetting, freezing) and prepare them for shipment according to IATA guidelines.
  • Subject Recruitment: Assist with pre-screening potential patients over the phone and reviewing medical history to see if they qualify for studies.
  • Administrative Support: Maintain study binders, organize supply inventories, and assist with scheduling patient visits.
Who We Are Looking For

We are specifically seeking individuals with a strong medical foundation who are eager to learn the regulations of research (GCP/FDA).

Required Qualifications:

  • Background: Must fall into one of the following categories:
  • Certified Nursing Assistant (CNA) with phlebotomy skills.
  • Certified Medical Assistant (CMA/RMA).
  • Foreign Medical Graduate (FMG) looking to gain US clinical experience.
  • Clinical Skills: Proficiency in phlebotomy (blood draws) and taking vitals is highly preferred.
  • Tech Savvy: Comfortable using computers, navigating electronic medical records (EMR), and learning new software quickly.
  • Soft Skills: Excellent bedside manner, empathy for patients, and a "no task is too small" attitude.

Preferred (But Not Required - We Will Train!):

  • Previous experience in a clinical research setting.
  • IATA certification (shipping dangerous goods).
  • GCP (Good Clinical Practice) certification.
Why Grow Your Career with Denali?
  • Mentorship: You will be paired with experienced CRCs who will teach you the "Denali Way" of research.
  • Career Pathway: We have a clear promotion track
  • Diverse Environment: We value the deep medical knowledge FMGs bring and the practical, hands-on efficiency of MAs and CNAs.
  • Standard Hours: Enjoy a more predictable schedule compared to hospital shifts or emergency care.
How to Apply

Please submit your email us at a brief statement explaining why you want to transition into Clinical Research. If you are an FMG, please highlight your medical background in your summary.

Not Specified
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Paralegal
🏒 Primis
Salary not disclosed
San Francisco Bay 1 week ago

Job Title: Paralegal – Social Security Disability (SSDI)

Location: Remote

Contract: 3–6 Month Contract


About the Role

We are seeking an experienced Paralegal with a strong background in Social Security Disability Insurance (SSDI) to support a busy legal team handling disability claims. This is a fully remote, 3–6 month contract ideal for someone who understands the SSDI process end-to-end and can step in quickly to help manage an active caseload.


Key Responsibilities

  • Manage SSDI and SSI disability cases from intake through hearing preparation
  • Prepare and submit documentation to the Social Security Administration (SSA)
  • Request, review, and organize medical records and supporting documentation
  • Draft correspondence, case summaries, and hearing briefs
  • Maintain accurate case files and track important deadlines
  • Communicate with clients, medical providers, and SSA representatives
  • Assist attorneys with Administrative Law Judge (ALJ) hearing preparation
  • Ensure compliance with SSA filing procedures and documentation requirements


Required Experience

  • 3+ years experience working with SSDI/SSI disability cases
  • Strong knowledge of SSA processes and disability claim procedures
  • Experience preparing cases for ALJ hearings
  • Ability to manage a high-volume caseload
  • Experience obtaining and reviewing medical records


Skills & Qualifications

  • Excellent organizational and case management skills
  • Strong written and verbal communication abilities
  • High attention to detail and ability to meet strict deadlines
  • Proficiency with legal case management systems and Microsoft Office
  • Ability to work independently in a remote environment


Preferred

  • Experience working at a disability law firm or SSDI advocacy organization
  • Familiarity with SSA electronic filing systems (EDCS / eView)
  • Paralegal certification or relevant legal training


The ideal candidate will be responsible for the collection and organization of documents and information from various cases at the firm. This candidate should feel comfortable relaying messages between various groups and keeping all documents important to the cases they are working on organized.

Disclaimer: Research indicates that men will apply to a role when they only meet 50-60% of the descriptions, however, when looking at women and other minority groups, they can look for up to a 99% match in order to apply to a role. If you feel you are a fit for our role, please still apply, don’t worry if you don’t tick every single box. We’d still love to hear from you. We encourage underrepresented talent to apply to all our roles & support accessibility needs

Not Specified
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Plumber (Must have a Valid Plumber's License)
Salary not disclosed
Atlanta, Georgia 1 week ago

Position Summary:

The Plumber installs and repairs plumbing fixtures, equipment and systems in accordance with regulations and safety standards.

Essential Duties:

  • Installs and repairs equipment and fixtures, including toilets, sinks, drains, gas/water lines, dishwashers, water coolers and water heaters.
  • Routes and cuts openings to accommodate installation or repair of equipment and fixtures and ease of maintenance.
  • Performs preventative maintenance by inspecting fixtures and making necessary repairs.
  • Repairs and maintains water supply, irrigation and sewage systems.
  • Certifies backflow devices and repair or install as required by code or standards.
  • Works rom building plans, blueprints and sketches to plan and layout routing and placement.
  • Organizes the job site ensuring it is properly staffed and has the necessary equipment.
  • Coordinates with other tradespersons completing projects when necessary.
  • Required to have prompt, regular attendance in-person and be available to work on-site, in-person during regular business hours and as needed.
  • Performs other duties as assigned by an appropriate administrator or their representative.

Knowledge, Skills, & Abilities:

  • Written and oral communication.
  • Computer skills.
  • Proficient in the installation and repair of all infrastructure plumbing lines and associated equipment such as, but not limited to, water and sewer lines, water fountains, lavatories, urinals.
  • Ability to correctly and safely operate all tools.

Minimum Requirements:

EDUCATION:

β€’ High School Diploma or GED required.

CERTIFICATION/LICENSE:

β€’ Valid Georgia driver's license.

β€’ Must comply with Transportation Regulation EDC-R.

β€’ Valid Plumber's License.

β€’ Requirements within 1 year of employment date: Must obtain backflow certification within one year of employment.

WORK EXPERIENCE:

β€’ 3 years of related work experience.

Salary Grade: 121

Salary Range: Salary Schedules - Atlanta Public Schools

Work Year: Annual

Physical Abilities and Working Conditions

The physical abilities, working conditions and other conditions of employment listed in this document are representative of, but are not intended to provide an exhaustive list of the requirements for positions in this classification. In the event of an emergency or situation requiring guidance from Federal, State, or local or school district authorities, the requirements of this position may change temporarily or for the school year to best serve the needs of our students.

Vision: Ability to read small print and view a computer screen for prolonged periods.

Hearing: Ability to tolerate exposure to noisy conditions.

Speech: Ability to be understood in face-to-face communications, to speak with a level of proficiency and volume to be understood over a telephone or computer.

Upper Body Mobility: Ability to use hands to grasp, and manipulate small objects; manipulate fingers, twist and bend at wrist and elbow; extend arms to reach outward and upward; use hands and arms to lift objects; turn, raise, and lower head. Strength: Ability to lift, push, pull and/or carry objects which weigh as much as 5 or more pounds on a frequent basis. Incumbent may be required to physically restrain parties involved in a conflict.

Environmental Requirements: Ability to encounter constant work interruptions; work cooperatively with others; work independently; work indoors.

Mental Requirements: Ability to read, write, understand, interpret and apply information at a moderately complex level essential for successful job performance; math skills at a high school proficiency level; judgement and the ability to process information quickly; learn quickly and follow verbal procedures and standards; give verbal instruction; rank tasks in order of importance; copy, compare, compile and coordinate information and records. Understand how to manage stress.

Remote Work Requirements:

Additional Work Conditions & Physical Abilities: Ability to be flexible and adapt as needed between various in-person working environments.

The Atlanta Public School System does not discriminate on the basis of race, color, religion, sex,citizenship, ethnic or national origin, age, disability, medical status, military status, veteran status, marital status, sexual orientation, gender identity or expression, genetic information, ancestry, or any legally protected status in any of its employment practices, educational programs, services or activities. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

This job description is intended to accurately reflect the duties, responsibilities and requirements of the position. It is not intended to be and should not be construed as an all-inclusive list of all the responsibilities, skills, or working conditions associated with the position. Management and administration reserves the right to modify, add, or remove duties and assign other duties as necessary.

Not Specified
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Senior Clinical Research Associate
🏒 Enigma Search
Salary not disclosed
San Francisco, California 1 week ago

Summary:

Our client is a clinical-stage biotechnology company focused on building the

leading, fully integrated platform for precision genetic medicines. Their approach centers

on developing and refining gene editing and delivery technologies to create effective,

safe treatments. At the core of their work is homology directed repair (HDR), a

proprietary method that allows us to make precise, predictable, and efficient changes to

specific DNA sequences.

By leveraging natural repair processes evolved over time, they maximize safety and

accuracy, enabling a broad range of therapeutic strategies. This foundation supports

their diverse portfolio of HDR-based programs aimed at delivering life-long cures for

serious diseases.

Their first clinical trial, is now approaching Phase II with a novel technology treating

Severe Sickle Cell Disease. Based on Phase 1 data from our first- and best-in-class

true gene correction, they anticipate momentum in the clinical trial with feedback from

FDA on our path towards regulatory approval.

Role:

A high-caliber and detail-oriented Clinical Research Associate (CRA) to

support the execution of the NEW clinical trial, a core clinical program advancing

the company's autologous gene therapy. This is a critical role within our growing

Clinical Operations organization.

As a CRA, you will be responsible for making sure clinical trial sites operate in full

compliance with protocol requirements, regulatory standards, and company's

quality expectations, while maintaining the highest standards of patient safety and data

integrity.

This role is designed for a proactive operator who excels in the operational complexities

associated with advanced therapeutic modalities. The ideal candidate thrives in a fast-

paced startup environment where precision, strong site partnerships, and early

identification of operational risks are essential to successful trial execution.

By overseeing day-to-day site monitoring activities, maintaining inspection-ready

documentation, monitor and verify site compliance with chain-of-identity (COI) and

chain-of-custody (COC) procedures associated with the autologous gene therapy

workflow, and promptly escalate deviations, the CRA plays a vital role in supporting the

successful execution of the NEW study.

Through disciplined site oversight and data quality management, this role enables the

clinical team to generate reliable data and advance company's clinical development

efforts.

Key Responsibilities:

Site Monitoring & Oversight:

o Conduct site qualification, initiation, monitoring (on‐site and remote), and

close‐out visits per the monitoring plan and risk‐based monitoring approach.

o Ensure compliance with protocol, ICH‐GCP, regulatory requirements, and

company SOPs.

o Perform source data review/verification and ensure documentation supports

clinical endpoints.

o Monitor site performance metrics and drive corrective actions with the Clinical

Trial Manager.

Participant Protection & Informed Consent:

o Verify informed consent is properly obtained and documented.

o Ensure ongoing compliance with updated consent forms and protocol

amendments.

o Confirm participant rights, safety, and confidentiality are maintained.

Autologous Gene Therapy Execution (COI/COC):

o Monitor adherence to chain‐of‐identity and chain‐of‐custody processes.

o Oversee compliance with apheresis/cell collection workflows and shipment

procedures.

o Ensure proper handling of temperature‐controlled and cryogenic shipments.

o Coordinate with manufacturing, logistics, and supply chain teams to align

collection and infusion schedules.

Investigational Product ' Materials Accountability:

o Ensure accurate accountability of investigational materials and ancillary

supplies.

o Verify storage conditions, temperature logs, and excursion management.

o Confirm documentation of product receipt, reconciliation, and

return/destruction where applicable.

Data Quality & Systems:

o Review EDC entries for completeness and accuracy.

o Resolve queries with sites and data management.

o Ensure timely and accurate safety reporting including SAEs.

Documentation & Inspection Readiness:

o Ensure investigator site files and trial master file documentation are complete

and inspection ready.

o Maintain accurate monitoring reports and follow‐up documentation.

o Support audit and regulatory inspection readiness activities.

Site Relationship Management & Training:

o Serve as the primary monitoring contact for assigned clinical sites.

o Provide training on protocol procedures, amendments, and operational

workflows.

o Build strong working relationships while maintaining compliance standards.

Qualifications:

Education:

o Bachelor's degree in life sciences, nursing, pharmacy, or related field

required. Advanced degree preferred.

Experience:

o 3+ years of clinical monitoring experience in biotech, pharma, or CRO

environments.

o Experience with cell therapy, gene therapy, oncology, or rare disease trials

preferred.

o Experience coordinating complex clinical logistics or centralized

manufacturing models is a plus.

The right candidate will have:

o Strong understanding of ICH‐GCP and regulatory requirements.

o Experience with EDC, CTMS, and electronic Trial Master File systems.

o Strong organizational skills and attention to detail.

o Ability to collaborate effectively across clinical, regulatory, manufacturing, and

supply chain teams.

Compensation:

The expected base salary range for this position is commensurate with experience and qualifications. Our client offers highly competitive equity participation, a performance-based incentive program, and a comprehensive benefits package designed to support employee well-being and professional growth.

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Associate Director, CSPV Clinical Study Startup/ICSR Standards
Salary not disclosed
Basking Ridge 1 week ago
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines.

With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.

Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary Will work with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations.

Oversees the creation of SAE Flow Plans and may perform final review.

Provide input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical Study Oversight Plan, day-to-day management of DS Safety Notification Letter (SNL) System and oversee TMF activities.

Interact with global study teams and represent PV operations in global interactions with CS Physicians and other study team members.

Oversee and may engage within CSPV and with CROs to execute study start up processes.

This level will handle problems requiring escalation from others and make decisions where appropriate and escalate any complex problems to the Director, Clinical Study Startup.

This position requires strong organization and interpersonal skills and is able to work effectively with people at different levels of an organization and different cultures.

Job Description Responsibilities Global PV Operations Representation on Clinical Study Teams: Represents PV Operations at multidisciplinary study meetings providing guidance on safety operations, oversight of initiatives and trouble-shooting issues.

Liaison for CS Physician and Data Management for study related safety reporting.

Will act as PV Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.

Global Management Strategy and Goals and Procedure Development: Assist Leadership to ensure compliance with protocol and internal/external standards.

Identifies and drives strategy for process improvement initiatives.

Reviews and provides input to SOPs, SOIs, and process guides.

Clinical Study Start-Up Documentation: Reviews all clinical study protocols to ensure consistency in safety requirements across studies related to a similar compound.

Develops and oversees the maintenance of the study specific SAE Flow Plan and collaborates with on behalf of CSPV Operations any other study related documentation such as the DMP, SOWs, PVAs, Clinical Study Oversight Plans, day-to-day management of DS Safety Notification Letter (SNL) System and presentations and documents.

Electronic Data Capture (EDC): In conjunction with Data Management, establish the EDC strategy at the project and/or study level.

Proactively identifies and manages risks at the project and/or study level as it relates to data capture and reporting.

Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.

Qualifications Education Qualifications Bachelor of Science degree required Master's degree, RN or PharmD preferred Experience Qualifications 4+ years of drug safety experience with technical experience in Electronic Data Capture and Safety Reporting required.

10+ years total pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferred.

Daiichi Sankyo, Inc.

is an equal opportunity/affirmative action employer.

Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range: USD$150,800.00
- USD$226,200.00 Download Our Benefits Summary PDF
Not Specified
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Director of Electrical Engineering
🏒 IAC
Salary not disclosed
Overland Park, KS 1 week ago

Position Summary

The Electrical Engineering Director will lead the design and execution of electrical engineering functions across capital projects, focusing heavily power distribution, low-voltage electrical control systems, instrumentation, and cross-functional team integration. This individual will serve as a department head, overseeing project execution, personnel development, technical excellence, and collaboration with automation, procurement, and construction teams.

The role is responsible for department strategy, resource allocation, technical review, project prioritization, and performance optimization within the Electrical Engineering function. A deep understanding of AutoCAD electrical CAD tools, controls, and field execution support is essential.


Primary Responsibilities

  • Lead, manage, and mentor the Electrical Engineering team (10+ team members).
  • Assign projects, track progress, and ensure on-time delivery of engineering packages.
  • Review and approve electrical control designs including schematics, panel layouts, and I/O assignments.
  • Provide guidance on EDC documentation, control narratives, and BOM development.
  • Collaborate with Automation Controls Engineers on PLC rack and HMI designs.
  • Oversee quality control inspections of control panels and ensure compliance with customer specs.
  • Ensure safe and effective designs for industrial control systems (low-voltage, 480V and under).
  • Coordinate with procurement, project management, fabrication, and field installation teams.
  • Support project startups and provide technical resolution on active job sites when necessary.
  • Help develop internal standards and support the professional development of team members.
  • Lead the department in adoption and standardization of AutoCAD Electrical and Revit for electrical design documentation.
  • Develop internal electrical design standards, procedures, and QA/QC review protocols.
  • Support proposal and estimating efforts as needed for electrical scope development.

Requirements

  • Bachelor’s degree in Electrical Engineering or closely related field.
  • 5+ years of experience in industrial engineering or OEM environments.
  • 3+ years in a leadership, project management, or department head capacity.
  • Strong ability to lead cross-functional teams and manage competing project priorities.
  • Experience reviewing or developing control system schematics, panel layouts, and instrumentation specifications.

Preferred Qualifications

  • 10+ years of experience in electrical controls, instrumentation, or design-build EPC environments.
  • Proficiency in AutoCAD Electrical (required); experience with Revit (preferred).
  • PE License or commitment to obtain (preferred, not required).
  • Familiarity with UL508A control panel standards and Class I/II Div 2 environments.
  • Background in startup/commissioning support and field engineering.
  • Knowledge of industrial systems in dust collection, bulk material handling, or air pollution control is a strong advantage.


About IAC

Established in 1986, IAC is a fast-track, high-technology equipment design and fabrication company specializing in Engineering, Procurement, and Construction (EPC) contracts across diverse industries. As a leading Industrial Design/Build Original Equipment Manufacturer (OEM), IAC focuses on process equipment for air pollution control, dust collection, hazardous gas mitigation, pneumatic material transport, and bulk material handling systems. With over 300 years of combined industry knowledge, IAC stands as a Single Source Solution Provider, strategically located in Kansas City to serve clients across North America.


About Adelphi Construction

A proud subsidiary of IAC, Adelphi Construction provides clients with a full suite of construction and field services, including capital improvement projects, shutdowns, turnarounds, and plant maintenance. Our commitment to long-term client satisfaction drives quality and consistency. Headquartered in the Kansas City metropolitan area, Adelphi’s personnel average 25+ years of experience, ensuring that every projectβ€”whether large-scale or mission-criticalβ€”is executed with safety, precision, and professionalism.


Why Work With IAC?

At IAC, we value integrity, innovation, and teamwork. Joining our engineering team means:

Being part of large-scale projects that make real industrial and environmental impact.

Collaborating with a talented, supportive team that celebrates success together.

Opportunities for professional growth, leadership, and technical advancement.

Access to comprehensive benefits including 401(k) with company match, health, dental, vision, PTO, and more.


Ready to Engineer What’s Next?

Apply today to help IAC deliver engineered mechanical solutions that move industries forwardβ€”cleaner, smarter, and stronger.


Please Note: We are not seeking assistance from outside recruiting agencies or third-party staffing firms for this position. Direct applicants only.

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