Alliance Clinical Trials Jobs in Usa
17,496 positions found
Clinical Trials Management Associate - II*
Santa Monica, CA
18 Months
- Manage 2 of their early and Phase IV (late) studies and a small portfolio of external trials
- Minimum 3 years of experience
- Targeting folks on cell therapy is good to have, but not mandatory
- Organize Meetings with management, stakeholders, and vendors
- Need to be heavily experienced in clinical trials management systems (CTMS)
- Coordinating contract reviews with vendors, outsourcing and administering aspects of trials
- Must meet all requirements for the Clinical Research Associate position and have demonstrated proficiency in all relevant areas.
- With limited supervision, conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
- Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines.
- Assists in CRO or vendor selection.
- With guidance from the supervisor, coordinates CROs or vendors.
- Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans. Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
- Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
- May participate in abstract presentations, oral presentations and manuscript development. Interfaces with individuals in other functional areas to address routine study issues.
- May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
- Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
- Travel is required.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Working knowledge and experience with Word, PowerPoint and Excel. Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
- Ability to develop tools and processes that increase measured efficiencies of the project.
- Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
- Must have a general understanding of functional issues and routine project goals from an organizational perspective.
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Clinical Trial Management System (CTMS) Specialist β OnCore
Location: Remote, must be in the U.S.
Openings: 10+, including Lead Specialists openings
Duration: Contract (Through June 1)
Start Date: ASAP
Position Overview
We are seeking an experienced CTMS Specialist with strong proficiency in OnCore to support a critical data migration project tied to our newly implemented CTMS. This role will focus on transferring clinical trial calendar and budget information from Excel into OnCore, ensuring accuracy, compliance, and readiness for go-live optimization.
Key Responsibilities
- Transfer study calendar data from Excel into OnCore
- Migrate and validate budget data within OnCore financial modules
- Perform quality control (QC) to ensure data accuracy and integrity
- Identify and resolve discrepancies between legacy Excel files and OnCore configuration
- Collaborate with clinical operations, finance, and IT stakeholders
- Support go-live readiness activities, including validation and testing
- Ensure alignment with institutional SOPs and regulatory compliance standards
- Develop documentation and provide knowledge transfer as needed
Required Qualifications
- Demonstrated hands-on experience with OnCore CTMS
- Experience building and managing study calendars within OnCore
- Strong knowledge of clinical trial budgeting workflows and build in OnCore
- Advanced proficiency in Microsoft Excel
- Strong understanding of clinical research operations
- Excellent attention to detail and data validation skills
- Ability to work independently in a fully remote environment
Location: Santa Monica, CA 90404
Duration: 18+ Months (Possibility of extension depending upon business requirements and performance)
Description:
- Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas.
- With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
- Assures site compliance with the routine protocol and regulatory requirements and quality of data.
- Assists in the setting and updating of study timelines.
- Assists in CRO or vendor selection.
- With guidance from supervisor coordinates CROs or vendors.
- Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
- Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
- Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
- May participate in abstract presentations, oral presentations and manuscript development.
- Interfaces with individuals in other functional areas to address routine study issues.
- May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
- Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
- Travel is required.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Working knowledge and experience with Word, PowerPoint and Excel.
- Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
- Ability to develop tools and processes that increase measured efficiencies of the project.
- Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
- Must have a general understanding of functional issues and routine project goals from an organizational perspective.
Highlights Practice has 4 Rheumatologists, 6 Physician Assistants, and an excellent support team Enjoy a great work-life balance with no evening or weekend hours Opportunities for clinical research and teaching residents + medical students With over 1,200 clinical trials, the practice has a nationally recognized clinical research program, and a well-regarded infusion center Work within a custom-built, state-of-art facility that includes an in-house lab, NCV testing, Digital X-ray, Hologic DXA, MSK ultrasound, peripheral MRI, total body MRI, 7 chair infusion suite, and sleep lab Compensation and Benefits Impressive base salary with production bonuses $20,000 Signing Bonus and $10,000 Relocation Partnership Track and Profit Sharing Comprehensive benefits package comprised of health and vision insurance (includes family), malpractice insurance, 401k retirement pension plan, 264 hours (more than 6 weeks!) PTO/CME with CME allowance, and much more Explore Altoona in Western Pennsylvania Altoona, a city in Western Pennsylvania, is a fantastic choice for families seeking affordability, community, and access to kid-friendly amenities.
With a population of 44k people, Altoona offers a small?town vibe without sacrificing conveniences.
Nestled in the Allegheny Mountains, it's an ideal spot for nature lovers, with hiking, biking, and skiing nearby.
Families will love the range of activities, such as historic amusement park, a children?s discovery center, a railroaders museum, and a planetarium.
Altoona is about 2 hours from Pittsburgh, roughly 3.5?hours from Baltimore and Washington, DC, and just under 4?hours from Philadelphia.
Overall, Altoona delivers a safe, family-friendly environment with solid schools, diverse youth activities, and easy access to urban centers.
Whether you're looking for a quieter lifestyle or a strategic location, Altoona is a hidden gem worth considering.
ES-71
Senior Clinical Trial Manager (Imaging Research)
Location: New Haven, CT (Hybrid: 2β3 days onsite)
Employment Type: Full-Time, Direct-Hire
Compensation: $110,000 - $115,000/year + Benefits
The Opportunity
Join an innovative research organization at the forefront of diagnostic development. We are seeking a proactive, highly organized leader to drive impactful imaging studies and advance our understanding of diseases through investigational radiotracers and quantitative imaging. This is a chance to manage high-stakes scientific discovery in a collaborative, cutting-edge environment.
Key Responsibilities
- Stakeholder Management: Build and maintain strategic relationships with study leadership, core staff, external vendors, and global sponsors.
- Financial Oversight: Manage study budgets, contracts, agreements, and change orders; collaborate with finance for invoicing and reconciliation.
- Project Lifecycle: Lead all project meetings (scheduling, agendas, and documentation) and track action items to ensure milestones are met.
- Regulatory & Compliance: Coordinate IRB submissions and ensure all projects adhere to strict regulatory standards.
- Operational Excellence: Track global project statuses, prepare executive metrics/projections, and identify opportunities for process improvement.
Qualifications
Minimum Requirements:
- Education: Bachelorβs degree in a relevant scientific or business field.
- Experience: 3+ years of direct experience in clinical research.
- Skills: Proven leadership in project management, critical thinking, and time management.
- Communication: Exceptional ability to lead calls and presentations with sponsors and internal teams.
- Location: Ability to work onsite in New Haven, CT, at least 2β3 days per week.
Preferred Qualifications:
- 5+ years of clinical research experience (with 3+ years specifically in Project Management).
- Deep understanding of GDocP, GCP, and clinical trial regulations.
- Knowledge of neurodegenerative disorders (e.g., Alzheimerβs, Parkinsonβs) is a plus.
- Experience navigating complex regulatory bodies.
Benefits & Perks
- Comprehensive Health, Dental, and Vision insurance.
- 401(k) Retirement Plan.
- Generous Paid Time Off (PTO).
- Life and Long-Term Disability insurance.
Unit Description:
The Infusion Nurse in Ambulatory Oncology provides chemotherapy and biologic therapies to adult patients with complex illness.Β Key aspects of this direct-care role include insertion of peripheral intravenous catheters; establishing access via utilizing implanted devices; administration of systemic chemotherapy and biotherapies; supporting the infusion patient who is participating in clinical trials; and comprehensive patient assessment and education.
EXPERIENCE:
- Greater than one year of registered nursing experience required
- Experience in infusion therapy, ambulatory care, oncology, or vascular access preferred
- Prior experience with peripheral IV insertion and care preferred
- Experience with central line access/deβaccess and PICC line care preferred but not required
On-call: Not required
Incentives: Weekend needs are every other with 7:00-15:30; 8-hour shifts. Weekend differential included!
Requirements:
- Current RN licensure or compact licensure recognized by the State of Vermont required.
- ADN required, BSN preferred.
- Appropriate experience in specific clinical area. Varies by unit.
Our Total Rewards Package includes:
- Health Care (Medical, Dental, Vision)
- Flexible Spending Account
- Retirement Benefits (403b)
- Insurance Benefits (Life, Long-Term, Short-Term)
- Paid time Time Off
Joining our team has its perks:
- We encourage professional growth and development
- We ensure our nurses are truly happy and feel valued
- We offer structured preceptorships and continuing education
- We are committed to great patient ratios
- Our team culture is unlike what you'll find at other hospitals
- We've made significant investments in safe patient handling and mobility equipment
- Nurses truly have a voice here through our shared governance
About the Area
Located in Burlington, the cultural hub of Vermont, you'll find all of the amenities of the best small cities, alongside the very best skiing and riding in the east (with six ski resorts within an hour of downtown). In Burlington, everyone can truly find what they're looking for to unwind; from Nordic skiing to mountain biking to backcountry touring.
Burlington has a robust food and music scene, with entertainment options for all ages. Designated the Healthiest City in the USA by the US Centers for Disease Control and Prevention. Burlington ranked highest in exercise, and among the lowest in obesity, diabetes and other indicators of ill health.
We offer a quality of life that is second to none in Burlington, the cultural hub of Vermont. With exciting signing incentives and relocation assistance, moving to Vermont has never been an easier decision.
Company Overview: At Alliance Clinical Network we're people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research.
We bring our energy and our passion to improving patient lives every day.
Position Overview: We are seeking a highly skilled and experienced Principal Investigator medical physician to join our team.
Clinical Research Coordinator
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:
The Clinical Research Coordinator (βCRCβ) monitors data management and regulatory aspects of clinical-trial operations and will ensure that research is conducted in accordance with the sponsorβs protocol, FDA Regulations, and ICH/GCP guidelines. The CRC will also ensure that the data provided to the sponsor are of the highest quality and that study enrollment meets or exceeds the sponsorβs expectations. As such, the CRC should be a detailed-oriented, self-motivated professional with a track record of successfully adhering to clinical-trial protocols and exceeding sponsor expectations.
Our primary therapeutic areas are pain, cardiometabolic health, and vaccines.
Estimated Start Date: March or April, 2026
DUTIES & RESPONSIBILITIES
- Completing all relevant training prior to study start and all additional protocol amendment trainings.
- Adherence to ALCOA-C Standards with all clinical trial documentation.
- Working effectively with EDC, CTMS, eSource, eRegulatory, and our internal database.
- Working effectively with sponsor specified IVRS and EDC systems.
- Conducting and overseeing study participant visits, and all other relevant protocol-required procedures -- including blood draws -- while documenting relevant data in a timely, accurate manner.
- Completing and overseeing data entry and query resolution in a timely manner as per company guidelines and sponsor expectations.
- Demonstrated understanding and implementation of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols.
- Liaising with the administrative staff, clinical investigators, research participants, and Sponsor/CRO representatives for assigned protocols.
- Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, organizational SOPs, and assigned study protocol(s).
- Maintaining a working knowledge of the recruitment and retention processes for the assigned protocol(s).
- Preparing for Sponsor and CRO visits for the respective protocol(s).
- Maintaining a comprehensive knowledge of the most recent versions of the Study Protocols, Informed Consents, Study Manuals, and all the other relevant study-related documents that are utilized for the assigned protocols.
- Managing study participantsβ scheduling, visit tracking, stipends, and transportation.
- Maintaining a comprehensive knowledge of all essential clinical trial documents and maintenance of the Investigator Site Binders for their assigned protocol(s).
- Work with the Principal Investigator(s) on the reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per Sponsor, IRB, and ICH-GCP Guidelines.
- Work supplementally with our recruitment team to pre-screen and schedule study participants.
KNOWLEDGE & EXPERIENCE
Education:
- Bachelor's degree in health or science-related major preferred but not mandatory
- ICH-GCP Certification and IATA Certification
- Phlebotomy Certification
Experience:
- 2-3 yearsβ experience in industry-sponsored clinical research, preferably as a CRC.
- Wide therapeutic range of clinical-trial experience preferred.
- Regulatory research experience is a plus.
Credentials:
- ACRP or equivalent certification is a plus
Knowledge and Skills:
- Goals-driven while continuously maintaining quality.
- Must be a detail-oriented and proactive self-starter.
- Must have strong written and verbal communication skills.
- Must have excellent customer service skills.
- Bilingual in Spanish is a plus.
Salary Range: $70,000 to $80,000 depending on experience and qualifications.
Physician Assistant β 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, MondayβFriday. 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.
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 (onβsite and remote), and
closeβout visits per the monitoring plan and riskβbased monitoring approach.
o Ensure compliance with protocol, ICHβGCP, 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 chainβofβidentity and chainβofβcustody processes.
o Oversee compliance with apheresis/cell collection workflows and shipment
procedures.
o Ensure proper handling of temperatureβcontrolled 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 followβup 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 Bachelorβs 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 ICHβGCP 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.
We are seeking a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate by coordinating and managing clinical research studies.
The OID Directorate conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations). In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators, and, when applicable, county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health.
CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.
Responsibilities
Primary Responsibilities
- Patient Recruitment and Consent: Identifies, recruits, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines.
- Help lead recruitment efforts, developing and refining strategies to meet enrollment targets.
- Make independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria.
- Manage and coordinate complex clinical trials: Handle complex logistics of trials, solve problems related to compliance or participant concerns, and make adjustments to protocols based on emerging situations during the study.
- Study Protocol Design and Oversight: Interprets study protocols, assessing feasibility, and modifies procedures to align with the objectives of clinical trials.
- Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures.
- Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS).
- Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings.
- Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines.
- Compliance and Regulatory Decisions: Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards, and addressing issues without minimal supervision by the Clinical Program Manager.
Regulatory Management
- Assists with Institutional Review Board (IRB) submissions and protocol amendments.
- Collaborate with principal investigators and sponsors and provide insights based on field experience.
- Recommend changes to improve study feasibility and evaluate the implications of protocol adjustments on ongoing activities.
- Ensures compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system.
Compliance and Monitoring
- Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle.
- Ensure that the research team follows procedures. Troubleshoot and resolve any deviations or challenges that may arise.
- Develop and implement quality control procedures, identify areas for improvement, and resolve any issues that could impact the validity or integrity of the study outcomes.
- Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies.
Regulatory Responsibilities
- Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements.
- Ensures all study-related documents are appropriately filed and accessible for audits.
- Manages study registrations and updates in the Clinical Trial Management System and eIRB system.
Other Responsibilities
- May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel.
- Remote and On-Site Study Leadership:
- Conduct research activities in varied environments, such as on naval ships or other remote sites, which may involve travel.
- Coordinate logistics, including equipment and resource allocation, and serve as a research team representative on-site.
- Make real-time decisions regarding study operations and troubleshoot unexpected scenarios to ensure study fidelity and safety.
- Performs other duties as assigned.
Responsibilities
Required
- A BA/BS in biological sciences, public health, or equivalent OR five (5) plus years of clinical research experience.
- Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes.
- Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems.
- Strong organizational, communication, and problem-solving skills.
- Ability to work both independently and collaboratively in a research setting.
- US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.
Preferred
- Certification in clinical research (such as CCRC or CCRP).
- Experience with infectious disease studies or military health research.
Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements
The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.
Physical Demands
- Constantly conduct sedentary work that primarily involves sitting/standing.
- Occasionally conduct light work that includes moving objects up to 20 pounds.
- Occasionally conduct medium work that includes moving objects up to 50 pounds.
- Occasionally push or pull less than 25 pounds, push or pull 25 - 45 pounds, or push or pull more than 45 pounds.
- Occasionally reach above shoulder level.
- Constantly use both hands.
- Occasionally stand or walk for more than 25 minutes.
- Occasionally bend, reach, or twist repeatedly.
- Occasionally kneel, squat, or stoop.
- Occasionally crawl or climb.
- Occasionally have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.
Physical Activities
- Occasionally ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like.
- Occasionally move self in different positions to accomplish tasks in various environments, including tight and confined spaces.
- Occasionally move about to accomplish tasks or move from one worksite to another.
- Constantly communicate with others to exchange information.
- Occasionally operate motor vehicles or heavy equipment.
- Constantly assess the accuracy, neatness, and thoroughness of the work assigned.
Environmental Conditions
- Occasional work in low temperatures.
- Occasional work in high temperatures.
- Occasional work in outdoor elements, such as precipitation and wind.
- Occasional work in noisy environments.
- Occasional work in small and/or enclosed spaces.
- Occasional work in environments where no adverse environmental conditions are expected.
PPE and Chemical Requirements
- Occasionally wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
- Occasionally wear a lab coat.
- Occasionally wear a disposable dust/surgical mask.
- Occasionally wear respirators, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA.
Please submit your resume online at CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.
Dana-Farber Cancer Center is hiring an experienced Oncology RN to coordinate cutting-edge clinical trials. Monday through Friday, no weekends, no holidays. The clinical Research Nurse will provide direct patient care to patients enrolled in or considering a clinical trial. In collaboration with the satellite physician(s), is responsible for the implementation and evaluation of clinical research in their specific program/area. The Research Nurse has expert knowledge of cancer as a disease process, cancer treatment modalities (or comparable knowledge for a non-oncology area, e.g. infection control) and the process of conducting medical clinical research. In addition, the Research Nurse utilizes evidence-based nursing practice and has expertise in developing and coordinating a plan of care designed to meet the physical, psychological, and social needs of those cancer patients and their families undergoing therapy in a clinical research trial. Specific duties and responsibilities may vary across the different satellite practices. The Mission, Vision and Core Values of the Dana-Farber Cancer Institute are incorporated into all areas of practice.
Job Description
ESSENTIAL FUNCTIONS
A. Administrative:
1. Assists principal investigator with protocol development.
2. Assists principal investigator as appropriate with the Institute's protocol review process.
3. Assists the principal investigator in developing the protocol budget.
4. Collaborates with the Dana-Farber Harvard Cancer Center DFHCC quality assurance of clinical trials office in developing protocol specific materials.
5. Serves as research coordinator for National Cancer Institute, pharmaceutical-sponsored, and National Cooperative Group protocols.
B. Research:
1. Assists with recruitment and registration of patients to clinical trials.
2. Coordinates scheduling of patient's laboratory and radiographic assessments, admissions and clinic visits.
3. Monitors test results as appropriate.
4. Coordinates protocol data management as necessary.
5. Collaborates with staff within the Institute and with outside organizations in the completion of clinical research trials.
6. Collaborates with physicians, staff and nurses in coordinating care and protocols.
C. Clinical:
1. Coordinates study enrollment, protocol treatment, and completion of study requirements for patients participating in clinical trials.
2. Works collaboratively and functions as an effective member of the health care team.
3. Collaborates with Care Coordination for all patient care referrals.
4. Collaborates with primary nurse and Oncology Nurse Navigator in assuring that patient care needs are met.
5. Provides protocol education to patients and families; adapts interactions based on age-specific needs of the patient.
6. Collects and prepares required specimens for analysis and monitors test results, as appropriate.
7. Documents in charts as appropriate and communicates observations and findings to protocol investigator and attending physicians.
8. Provides protocol in-service training and serves as a resource to the health care team.
9. Monitors the environment of care with attention to patient safety and assures compliance with regulatory agency standards.
10. Maintains clinical practice that is evidence-based and consistent with nursing policies, procedures, licensure/registration requirements, and professional scope and standards.
11. Participates in QA/QI projects for the clinical program and the Division of Nursing and Patient Care Services.
12. Adheres to the Code of Ethics for Nurses with Interpretive Statements (ANA, 2015) in all aspects of professional practice.
13. Fosters an environment that is sensitive to the needs of diverse populations, including but not limited to culture, ethnicity, gender, and age.
14. Administers medications as necessary.
15. Maintains BLS certification.
16. Adapts to site specific policies, procedures and processes, communicates variations to Director of Research.
17. Quickly builds relationships with patients across multiple settings, supports the role of the primary nurse and Oncology Nurse Navigator.
18. Demonstrates understanding of special needs and behaviors of age groups of the population served.
D. Professional Development:
1. Orientation and training will take place at DFCI main campus and/or DFCI satellite locations.
2. Identifies areas for professional growth.
3. Formulates professional goals, objectives and methods for accomplishing these.
4. Pursues active membership of local and national professional organizations.
5. Supports research activities within the Division of Nursing and Patient Care Services.
6. Participates in Division of Nursing / Institute committees at the main DFCI Longwood campus, including, but not limited to, the monthly Research Nurse Practice Committee meeting.
7. Meets all annual evaluation requirements and competencies within the established time period.
8. Collaborates in preparing professional reports, articles, and presentations for colleagues and the public.
JOB REQUIREMENTS
Minimum Education
Graduate of an accredited School of Nursing as validated through the Massachusetts Board of Registration in Nursing
Baccalaureate degree in nursing strongly preferred. If associate degree in nursing, must complete BSN degree within 4 years
Minimum Work Experience
Minimum of 1-year recent experience as an RN
Ambulatory and/or oncology experience preferred
Required Licenses / Registrations
RN - Registered Nurse in Massachusetts
Required Classes/Skills
BLS - Basic Life Support.
ACLS - Advanced Cardiac Life Support accepted as minimum requirement
Professional nursing certification preferred (OCN, BMTCN, CPHON, AOCNP, CRNI, RN-BC)
Required additional Knowledge and Abilities
Demonstrated flexibility and ability to work as an effective member of an interdisciplinary team.
Demonstrated skills in critical thinking, problem solving, and ability to make independent decisions.
Strong Computer skills preferred
Strong interpersonal, organizational and communication skills are required.
Knowledge of current literature and a commitment to continued learning required.
Position requires travel to all DFCI satellite locations and the ability to quickly assimilate to new environments and foster team relationships at each site.
Clinical Research Coordinator
ICON plc is a world-leading healthcare intelligence and clinical research organization. Weβre 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 youβll 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
Early development Oncology - phase I
3-4 protocols, 8-10 sites
4+ years of CRA experience at a CRO
We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
What You Will Be Doing:
- Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
- Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
- Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
- Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
- Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
Your Profile:
- Advanced degree in a relevant field such as life sciences, nursing, or medicine.
- Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
- Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
- Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
- Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
- Must be located in the LA or SF Bay area
- Five years of CRA experience with phase I oncology monitoring experience
- Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driverβs license
Sr Clinical Research Coordinator - Cary, NC
ICON plc is a world-leading healthcare intelligence and clinical research organization. Weβre 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 youβll 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
Location: 1 Day a week onsite in NYC
Salary: $140-180k Base plus bonus
Scientific Search has partnered with a clinical-stage pharmaceutical company pioneering novel approaches to treating cancer. The role of Senior Clinical Project Manager will report to the Associate Director, Clinical Project Management, and work collaboratively across functions to manage clinical activities that will bring novel cancer therapeutics to patients in need. The Senior Clinical Project Manager will be assigned to one or more clinical trials and be responsible for the day-to-day operations of the trials.
Responsibilities
- Plans, implements and monitors progress of assigned clinical trials from start up to closeout
- Collaborates with cross functional study team to execute clinical study deliverables
- Tracks and manages deliverables from CROs and vendors
- Develops and manages tools to track clinical study progress
- Ensures compliance with SOPs, GCP and other applicable regulations
- Escalates study-related issues as appropriate
- Prepares and provides clinical study updates
- Participates in development/review of study documents and plans
- Reviews and approves study plans generated by CROs and vendors
- Reviews site informed consent drafts
- Proactively identifies risks and helps to implement mitigation strategies
- Implements enrollment and retention strategies
- Reviews and approves IP release packages
- Manages IP accountability and reconciliation processes
- Monitors clinical data collection, and reviews clinical data for completeness and accuracy
- Reviews monitoring reports to assess site performance
- Reviews and reconciles study related invoices
- Supports and participates in clinical team initiatives
- Bachelorβs degree in a relevant field
- Minimum of 3 years of relevant industry experience, including at least 1 year in a Sponsor role at a biotech or pharma company
- Experience in management of in-house and outsourced clinical trials
- Experience in early phase clinical trials
- Experience in oncology
- Strong working knowledge of ICH GCP guidelines and project management concepts
The Clinical Research Nurse (CRN) at PIH Health Hospital is responsible for the coordination and delivery of patient care and clinical trial support within a hospital-based research setting. The CRN ensures that clinical studies are conducted in compliance with federal regulations, Good Clinical Practice (GCP), institutional policies, and ethical standards, while prioritizing patient safety and data integrity.
PIH Health is a nonprofit, regional healthcare network that serves approximately 3 million residents in the Los Angeles County, Orange County and San Gabriel Valley region. The fully integrated network is comprised of PIH Health Hospital - Whittier, PIH Health Hospital - Downey and PIH Health Good Samaritan Hospital, 27 outpatient medical locations, a multispecialty medical (physician) group, home healthcare services and hospice care, as well as heart, cancer, womenβs health, urgent care and emergency services. The organization is recognized by Watson Health as one of the nationβs Top Hospitals, and College of Healthcare Information Management Executives (CHIME) as one of the nationβs top hospital systems for best practices, cutting-edge advancements, quality of care and healthcare technology. PIH Health is certified as a Great Place to WorkΒ TM. For more information, visitΒ Β or follow us onΒ Facebook,Β Twitter, orΒ Instagram.
Required Skills
- The clinical trial nurse is required to have comprehensive knowledge in all areas of protocol design, strong clinical assessment and decision-making skills, ability to navigate fast-paced hospital environments, manage multiple studies, excellent communication and patient education abilities, knowledge of federal regulations (FDA, OHRP), ICH-GCP guidelines, and HIPAA, proficient in EMRs and clinical research platforms (e.g., Epic, REDCap, Medidata, OnCore). Β
- Must be knowledgeable in internet access to manage clinical trials case report forms.Β
- Proficient with computerized and manual data collection.Β
- Familiarity with word processing and spreadsheet computer programs.Β
Required Experience
Required:
- Current California RN license
- Basic Life Support (BLS) CPR Card through American Heart Association
- Minimum 2 years of clinical nursing experience in Oncology / Hematology
Β
Preferred:
- Bachelor of Science in Nursing (BSN) or masterβs degree (MSN)
- Certified Clinical Research Professional (CCRP)Β
- Board Certification in area of specialtyΒ
- Prior experience with clinical trials or research coordination is strongly preferredΒ
Address
12401 Washington Blvd.
Salary
52.50-84.25
Shift
Days
Zip Code
90602
Clinical Operations Intern
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Clinical Operations intern supports clinical trial activities and works closely with the clinical operations team to ensure department activities are conducted according to required activity quality standard.
Responsibilities
- General administrative support to the clinical operations department.
- Assist in managing trial timelines.
- Assess and provide feedback on approaches to maximize efficiencies and identify opportunities for improvement.
- General administrative support of clinical operations department storage platforms (e.g. Sharepoint, etc.)
- Assist in tracking of trial activities which may include but are not limited to feasibility, site selection, participation status, regulatory or ethics status.
- Participates in department and/ or clinical trial team meetings and participate in collaborative efforts.
Qualifications
- Undergraduate student; junior or senior preferred.
- Understanding of study phases and general knowledge of how they apply to clinical development is preferred.
- Knowledge of Word, Excel, SharePoint and PowerPoint.
- Strong verbal and written communication skills required.
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- Flexible Approved Time Off
- Tuition Reimbursement
- 401k Retirement Plan
- Work From Home Anywhere in the US
- Maternal/Paternal Leave
- Casual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
#LI-Remote
Position title:
Instructor (Non-Senate, Non-Tenure Track)
Salary range:
The compensation model varies depending upon the course delivery format. For a synchronous Live Online course, a reasonable estimate for this position is $1,500 - $4,500 total per course. For an asynchronous Fixed Date Online course, this position is paid $200 - $350 per enrolled student and a reasonable estimate ranges from $1,600 -$5,250 total per course. Instructor compensation is determined by course length, number of units, enrollment, budgetary considerations, and other factors.
Percent time:
Part-time by agreement on a course-by-course basis.
Anticipated start:
Some appointments may begin as early as the spring semester.
Review timeline:
Applicants are considered for positions as needs arise; the existence of this applicant pool does not guarantee that a position is available. The applicant pool will remain in place for 9-12 months; those interested in remaining in the applicant pool beyond the advertised final closing date must reapply.
Position duration:
Length of courses differs depending on the subject, level, format/schedule, and credits taught. For the fall, spring, and summer semesters, course length typically ranges from approximately 2 days to 8 weeks. Further course agreements may be assigned based upon program needs, meritorious performance, and funding availability.
Application Window
Open date: August 27, 2025
Next review date: Monday, Mar 23, 2026 at 11:59pm (Pacific Time)
Apply by this date to ensure full consideration by the committee.
Final date: Wednesday, Aug 26, 2026 at 11:59pm (Pacific Time)
Applications will continue to be accepted until this date, but those received after the review date will only be considered if the position has not yet been filled.
Position description
UC Berkeley Extension (UNEX), the continuing education branch of the University of California, Berkeley, has been building bridges between UC Berkeley and the public since 1891. UNEX serves the professional and continuing education goals of thousands of people each year and plays an essential part of the University mission to: extend the research and scholarship of UC Berkeley to a global community; increase access to higher education for non-traditional, online, and international students; and improve the workforce. UC Berkeley Extension is a part of the division under the leadership of the Dean of Extended Education that also includes Berkeley Summer Sessions, Berkeley Study Abroad, and Osher Lifelong Learning Institute.
UC Berkeley Extension invites applications for a pool of qualified, dynamic instructors with a commitment to undergraduate, professional, and continuing education in Clinical Research, Regulatory Affairs, and Biotechnology to teach one or more online courses each year for our Sciences, Mathematics, and Biotechnology department.
Courses are offered online:
- Online instruction is delivered asynchronously through our learning management system (Canvas) or through synchronous live lectures (Zoom).
- Most synchronous live online lecture courses are offered in the evening and on the weekend (U.S.A. Pacific Time).
Course Subjects
We are seeking qualified applicants who possess current subject matter expertise and/or teaching knowledge in (but not limited to) the following course subjects. For program and course descriptions, please refer to the departmental link below.
Clinical Research
- Introduction to Clinical Research: Clinical Trial Phases and Design
- Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities
- Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting
- Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management
Regulatory Affairs
- Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices
- Submissions and Commercialization
- Preparation, Submission and Agency Interfacing
- Harmonization Across Worldwide Applications
- Post-Approval Activities
- Principles of Supply Chain and Manufacturing
- Principles of Product and Process Development
- Principles of Quality and Compliance
- Regulatory Compliance for Pharmaceutical Products
Other Biotechnology Courses
- Drug Development Process
- Other Biotechnology course topics (please specify in your cover letter)
Teaching Experience
- Classroom Teaching Experience
- Synchronous Online Teaching Experience (online lectures via Zoom)
- Asynchronous Online Teaching Experience (via learning management system)
General Duties
The department seeks candidates who can support the success of all students through inclusive curriculum, classroom environment, and pedagogy. Specific duties and expectations will vary depending on the method of instruction including: Synchronous Live Online (Zoom) or Asynchronous Online (Fixed Date).
- For synchronous instruction (live online courses), duties include but are not limited to: syllabus development; assignment development; lesson planning for class meetings; preparing and submitting required texts and course materials; reviewing and updating Canvas course site; and delivering lectures, presentations, and learning activities for all required hours of instruction.
- For asynchronous instruction (fixed date online courses), duties include but are not limited to: reviewing the syllabus and pre-populated online course content; learning and utilizing Canvas classroom management tools; and requesting any training needs from the Program Director or Department Director.
- For all instruction (regardless of course format) duties include but are not limited to: completing required trainings as mandated by the UC Presidential policies; responding to student questions and learning needs in a timely manner; grading student assignments and posting final student grades to the instructor portal in a timely manner; utilizing University-approved course support platforms including the Canvas Learning Management System, Zoom, Instructor Portal, Google Workspace, etc.; reviewing and following University and departmental policies, logistics, and other guidelines as published on the departmental Instructional Resource Site; and responding to other requests from the Program Director or Department Director in a timely manner.
Clinical Research Conduct and Management Program: public/category/ ?method=load&certificateId=17168&selectedProgramAreaId=15498&selectedProgramStreamId=15604
Regulatory Affairs Program: public/category/ ?method=load&certificateId=17180
Clinical Research, Regulatory Affairs, and Biotechnology Courses: academic-areas/sciences-and-biotechnology/?nav=5#!?tab=courses&programStream=Life%20Science%20Business%20and%20Biotechnology
Qualifications
Basic qualifications (required at time of application)
- Advanced degree
Additional qualifications (required at time of start)
U.S.A. Residency and U.S.A. Work Authorization: All work must be performed in the United States, whether in person or online. For applicants who are not US citizens or permanent residents, a valid US work authorization is required for the duration of employment. Applicants should not expect the department to sponsor a work visa on their behalf.
Preferred qualifications
- Doctorate degree or equivalent international degree in course subject.
- 3 or more years of teaching, training, or coaching experience in the course subject at a U.S. college/university institution, or within a U.S. Clinical Research, Regulatory Affairs, or other Biotechnology corporate environment.
- Knowledge of federal and California state laws and regulations as applicable to the course subject.
- Professional license, certification, or credential within a Clinical Research, Regulatory Affairs, or other Biotechnology field.
- Experience in creating syllabi, learning objectives, lectures/presentations, learning activities, assignments, assessments, exams, and quizzes.
- Experience teaching and/or developing academic content for online courses.
- Ability to convey conceptual and complex ideas and information.
- Ability to support the success of all students through inclusive curriculum, classroom environment, and pedagogy.
- Effective verbal/written communication and presentation skills (English).
- Effective organizational skills with attention to detail.
- Ability to collaborate with colleagues and work within a team environment.
- Proficiency in (or willingness to learn) instructional and other technology, such as: Learning Management Systems (Canvas); lecture/presentation capture applications (Panopto); online video conferencing (Zoom); Microsoft Office (Word and PowerPoint); file sharing (Google drive or Dropbox); and Google Workspace tools (email, calendar, docs, sheets, slides, etc).
Application Requirements
Document requirements
Curriculum Vitae - Your most recently updated C.V.
Cover Letter - Please discuss prior teaching experience, teaching approach, and other/future teaching interests. This can include, for example, specific efforts, accomplishments, and future plans to support the success of all students through inclusive curriculum, classroom environment, and pedagogy.
Reference requirements
- References are requested from candidates at the interviewing stage, and references are only contacted for finalists.
Apply link:
JPF04761
Help contact:
About UC Berkeley
UC Berkeley is committed to diversity, equity, inclusion, and belonging in our public mission of research, teaching, and service, consistent with UC Regents Policy 4400 and University of California Academic Personnel policy (APM 210 1-d). These values are embedded in our Principles of Community, which reflect our passion for critical inquiry, debate, discovery and innovation, and our deep commitment to contributing to a better world. Every member of the UC Berkeley community has a role in sustaining a safe, caring and humane environment in which these values can thrive.
The University of California, Berkeley is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or protected veteran status.
For more information, please refer to the University of California's Affirmative Action and Nondiscrimination in Employment Policy and the University of California's Anti-Discrimination Policy.
In searches when letters of reference are required all letters will be treated as confidential per University of California policy and California state law. Please refer potential referees, including when letters are provided via a third party (i.e., dossier service or career center), to the UC Berkeley statement of confidentiality prior to submitting their letter.
As a University employee, you will be required to comply with all applicable University policies and/or collective bargaining agreements, as may be amended from time to time. Federal, state, or local government directives may impose additional requirements.
Unless stated otherwise, unambiguously, in the position description, this position does not include sponsorship of a new consular H-1B visa petition that would require payment of the $100,000 supplemental fee.
As a condition of employment, the finalist will be required to disclose if they are subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct.
- "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment or discrimination, as defined by the employer.
- UC Sexual Violence and Sexual Harassment Policy
- UC Anti-Discrimination Policy
- APM - 035: Affirmative Action and Nondiscrimination in Employment
Job location
San Francisco Bay Area, California, U.S.A.
CRA II
local/very regional travel
US, Clinical Research Associate, Sponsor Dedicated
ICON plc is a world-leading healthcare intelligence and clinical research organization. Weβre 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
We are currently seeking a Clinical Research Associate II in Miami, FL to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
- Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
- Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
- Collaborating with investigators and site staff to facilitate smooth study conduct.
- Performing data review and resolution of queries to maintain high-quality clinical data.
- Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
- Bachelor's degree in a scientific or healthcare-related field.
- Minimum of 2 years of experience as a Clinical Research Associate.
- In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
- Strong organizational and communication skills, with attention to detail.
- Ability to work independently and collaboratively in a fast-paced environment.
- Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driverβs license