Pharmacy Jobs in Usa

JOB OVERVIEW:

The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support.

KEY ROLES/RESPONSIBILITIES:

• Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
• Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
• Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
• Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
• Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
• Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
• Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
• Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
• Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
• Represent Technical Services at project team meetings and provide sound technical advice.
• Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
• Directly interact with Piramal Pharma Solutions clients.
• Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.

EXPERIENCE:

• Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
• Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulates, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
• Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidance, and general compliance expectations.
• Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
• Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
• Technical writing experience is required with attention to detail skills essential.
• Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
• Must have proficiency in the Microsoft Office Suite programs.
• Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
• Ability to work effectively managing multi projects at a fast pace withcross-functional departments and manage priorities to meet timelines.
• Must be innovative, proactive, resourceful and committed to continuous improvement.
• Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.

WORK ENVIRONMENT:

The position requires the ability to work in ahigh demand office and manufacturing setting with time spent performing "on the floor" activities in laboratory and manufacturing areas. The position may require extended hours including evenings and weekends as well as work hours on 2nd and 3rd shifts depending on project needs.

Pharmacy Prior Authorization Specialist

Plano, TX (Fully Onsite)

$21 – $28 per hour

Monday – Friday | 8:30 AM – 5:00 PM

About the Role

We are seeking a Pharmacy Prior Authorization Specialist to support complex specialty medication workflows and ensure timely access to therapy for patients. This role plays a critical part in managing prior authorization processes, coordinating with insurance payers, and collaborating with clinical and pharmacy teams.

The ideal candidate is detail-oriented, proactive, and comfortable navigating insurance systems while communicating with payers, patients, and healthcare professionals. Candidates with pharmacy or healthcare insurance experience who enjoy problem-solving and working in a fast-paced environment will thrive in this role.

Key Responsibilities

Prior Authorization & Benefits Coordination

• Contact insurance companies to obtain real-time status updates on prior authorization requests
• Run benefit investigations and gather documentation needed for commercial insurance authorizations
• Check status daily on pending authorizations and ensure timely follow-up
• Assist with continuation authorizations for existing patients

Documentation & Data Management

• Accurately enter approval letters, authorization numbers, and related documentation into internal systems such as CareTend
• Enter patient demographics, diagnosis information, and payor data into the electronic medical record
• Maintain detailed records of payer interactions including reference numbers and next steps

Denial Review & Workflow Management

• Review denial letters and ensure documentation is complete before routing cases to clinical teams for review and appeals
• Monitor authorization queues to prevent delays in patient therapy initiation or continuation
• Conduct patient chart audits and maintain current documentation files

Collaboration & Communication

• Coordinate with pharmacy operations, intake teams, clinical staff, and revenue cycle teams
• Communicate authorization outcomes and documentation needs to internal teams
• Maintain professional communication with insurance representatives, patients, and referral sources

Required Qualifications

• High School Diploma or GED
• 1+ year of experience in a pharmacy, healthcare, or medical insurance environment
• Experience with prior authorizations, benefits verification, or insurance coordination
• Strong attention to detail and data entry accuracy
• Ability to manage multiple tasks and changing priorities in a fast-paced environment
• Experience with Microsoft Office (Excel, Outlook, Word, Teams)

Preferred Qualifications

• Pharmacy Technician Certification (preferred but not required)
• Experience with CareTend or similar pharmacy/authorization platforms
• Knowledge of Medicare, Medicaid, and commercial insurance plans
• Experience in pharmacy billing, specialty pharmacy, or medical insurance verification

Validation Engineer

Contract: 6+ month duration with potential for extensions

Location: Woodstock, IL - ONSITE

Shift: First-shift hours; flexibility to support project timelines required

Industry: Sterile Liquids Manufacturing

Automated Systems, Inc. is seeking a highly capable Validation Engineer to support validation activities for Blow-Fill-Seal (BFS) equipment, with additional scope across compounding and packaging systems.

You will be working within a dynamic CDMO environment specializing in ophthalmic, inhalation, and irrigation products, helping to ensure all systems meet current Good Manufacturing Practices (cGMP), FDA, and client quality expectations.

Key Responsibilities:

• Lead and execute validation lifecycle documentation (URS, IQ, OQ, PQ) for Blow-Fill-Seal equipment used in sterile liquid product manufacturing.
• Support validation of compounding systems, including mixers, tanks, and associated CIP/SIP systems.
• Perform packaging line validation for sterile fill finish operations.
• Collaborate with cross-functional teams (QA, Engineering, Operations) to execute validation deliverables according to project timelines.
• Write and manage change controls, deviations, and CAPAs related to validation activities.
• Ensure all validation work aligns with internal SOPs, regulatory expectations, and customer-specific requirements.
• Assist in audit readiness activities and represent the validation function during inspections or client visits.
• Contribute to continuous improvement initiatives by identifying gaps and optimizing validation practices.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related technical field.
• Minimum 4 years of experience in pharmaceutical or medical device manufacturing.
• 4+ years of direct validation experience, including hands-on protocol generation and execution.

Preferred Qualifications:

• Strong understanding of BFS technology, sterile processes, and related regulatory standards (21 CFR Part 11, EU Annex 1, etc.).
• Experience in CDMO environments and third-party client interactions is preferred.
• Familiarity with ASTM E2500, GAMP 5, and risk-based validation approaches.

Role:

The Intake Specialist role works to support the Patient Assistance Program (PAP) through providing initial triaging of patient applications, including data entry and coordination of work through the appropriate channels as determined by established business rules.

Responsibilities:

•Completes the intake process of all applications into Customer Relationship Management System (CRM)

•Associates and tags all images to the patient, data enters all information including patient demographic information, physician information, drug information, and all relevant application data such as income information, household information and insurance information into the CRM

•Conducts initial assessment of application for missing information and completes missing information patient outreach process to obtain required data

•Completes initial assessment of simplified application

•Identify appropriate work flow based upon business rules

•Collaborate cross functionally to ensure processes are followed according to business rules and policies

•Ensure all patient cases are documented in the CRM in accordance with all business rules and policies

•Conduct renewal and year end recertification’s process as determined by the Patient Assistance Program

•Readily assists on special project within job scope to improve reimbursement optimization when requested by management

Manages incoming and outgoing mail

Qualifications:

•High school diploma or equivalent required. College or a 2-year Associate Degree is preferred

•A minimum of 1-3 years’ experience within an office or administrative setting

•Exposure to core insurance (Medical and Pharmacy Benefit) knowledge a plus

•Strong attention to detail and work independently with minimal direction

•High quality customer service skills

•Ability to express ideas clearly in both written and oral communications

Job Title: Pharmacist (Berlin, CT)

Role Overview:

As a Pharmacist with the team, you will drive pharmacy management goals by providing comprehensive, accurate, and efficient dispensing services for both routine and emergency needs. Relying on strong management skills and meticulous attention to detail, you will ensure customers receive the right medications safely and on time.

Essential Functions:

Operations & Leadership

• Manage Daily Workflow: Execute day-to-day pharmacy operations to consistently meet production quotas, delivery schedules, and deadlines.
• Supervise Staff: Oversee pharmacy production staff to ensure efficient order entry workflow, facility security, and overall team performance.
• Clear the Queue: Ensure the workflow dashboard is fully cleared on a daily basis.

Dispensing & Quality Assurance

• Ensure Accuracy: Meticulously verify the completeness, content, and accuracy of all new and refill orders, labels, and drug packaging.
• Compound IV Products: Prepare and/or supervise the compounding of all sterile IV drug products and solutions.
• Manage Controlled Substances: Handle the proper ordering, receiving, documentation, and secure storage of controlled substances, including maintaining a perpetual inventory for Schedule II drugs.

Compliance & Standards

• Maintain Regulatory Compliance: Ensure strict adherence to all local, state, and federal laws, HIPAA guidelines, and third-party payer contracts.
• Follow DEA Policies: Enforce and comply with all DEA policies and procedures, strictly following whichever regulatory standard is most stringent.
• Adhere to Internal Policies: Follow all departmental guidelines regarding safety, attendance, and dress code.

Minimum Education and Experience Requirements:

• Bachelor of Science Degree in Pharmacy or PharmD from an accredited School of Pharmacy
• Current state license to practice pharmacy in good standing.

Schedule/ Shift:

Monday, Tuesday, Thursday, Friday: 3:30 pm-12am

Every other weekend 7 am to 6 pm. (Wednesday is always off)

Benefits:

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances)
• Health Benefits / Dental / Vision (Medix Offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s).)
• 401k (eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1)
• Short Term Disability Insurance
• Term Life Insurance Plan

Company Description

Spiras Health delivers personalized healthcare services at home, focusing on patients at high risk of emergency events or hospitalizations. By addressing the unique needs of individuals with chronic diseases, multiple health conditions, and other social determinants of health, Spiras Health enhances quality of life and reduces healthcare costs. Through collaboration with health plan providers and care management teams, the company employs local Clinical Care Teams to deliver tailored home-based care. Leveraging innovative technology, Spiras Health ensures efficient and effective program delivery. For more information, visit .

Who We Are:  Excellence, Innovation, Passion, Compassion, Communication

Spiras Health is a value-based, nurse practitioner led clinical provider of care-at-home and other health-related services to individuals with complex and polychronic needs. Spiras’ comprehensive approach to care delivery includes a combination of home-based services, telehealth, two-way digital communications, and remote patient monitoring. Proprietary predictive modeling identifies and assesses individuals with an elevated probability of avoidable costs. Spiras Health then develops actionable plans of care, addresses barriers including social determinants of health and delivers high quality patient care in collaboration with the patient’s treating physicians. Spiras’ innovative multi-modal care approach delivers improved satisfaction and clinical metrics as well as financial savings to its partners, through a geographically and economically scalable delivery model. Our culture is anchored on a promise of full accountability and integrity in everything we do.

How We Serve:

The Senior Data Analyst, in partnership with the Chief Financial Officer and Chief Commercial Officer, will design and develop market and opportunity analysis, monitor and measure contract performance, and model operational strategies and initiatives. Additionally, this role offers opportunity to engage with senior management and business unit leaders, contributing key insights that inform strategic decision making that ultimately supports the company’s growth.

Job Summary:

The Sr Analyst - Data & Analytics owns the integrity, analysis, and interpretation of payer claims data to support performance measurement, utilization management, and value-based care initiatives. This role is hands-on and accountable for claims QA, utilization metrics, and analytics outputs used by clinical, operations, and executive stakeholders.

This is an individual contributor role with strong technical depth in payer claims data and healthcare analytics platforms, including MedeAnalytics.

Key Responsibilities

Claims Data Quality & Governance

• Own QA processes for medical and pharmacy claims data, including eligibility, provider, diagnosis, procedure, and financial fields
• Identify, quantify, and resolve data anomalies (e.g., lag, duplication, missing claims, inconsistent coding)
• Partner with data engineering, vendors, and payers to remediate data quality issues
• Define and maintain claims data validation rules and documentation

Analytics & Utilization Management

• Analyze and report on core utilization metrics, including:
• Inpatient admits / 1,000
• ED visits / 1,000
• Readmissions
• PMPM cost trends
• Length of stay
• Avoidable admissions
• Apply payer benchmarks (national, regional, risk-adjusted where applicable) to contextualize performance
• Support matched cohort, pre/post, and trend analyses
• Translate claims data into actionable insights for clinical and operations teams

Platform Ownership (MedeAnalytics)

• Serve as a power user and analytics owner of the MedeAnalytics platform
• Build, validate, and QA dashboards, reports, and analytic views
• Ensure alignment between platform outputs and internal data models
• Act as internal SME for MedeAnalytics capabilities and limitations

Stakeholder & Team Collaboration

• Partner closely with:
• Clinical leadership
• Operations
• Finance
• Growth
• Present findings to senior leadership in clear, non-technical language

Required Qualifications

• 5–8 years of healthcare analytics experience
• Deep experience working with payer medical and pharmacy claims data
• Strong understanding of utilization metrics and healthcare cost drivers
• Hands-on experience with MedeAnalytics (required)
• Advanced SQL/SAS skills; experience with data visualization tools (Tableau, Power BI, or equivalent)
• Proven ability to QA complex healthcare datasets
• Bachelor’s degree in Analytics, Statistics, Health Informatics, or related field

Preferred Qualifications

• Experience supporting value-based care, MA, D-SNP, or ACO programs
• Familiarity with HEDIS, Stars, or CMS reporting concepts
• Experience with risk adjustment (HCCs)

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• This job operates in a hybrid professional environment free from noise and distraction. This role routinely uses standard office equipment such as computers and phones.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. 
• While performing the duties of this job, the employee is regularly required to talk and hear.
• This position requires the ability to occasionally lift office products and supplies, up to twenty pounds.

EEOC STATEMENT:  

• All qualified candidates will receive consideration for employment without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical conditions related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, or sexual orientation.  

We are seeking an experienced Contract Project Manager to lead the design, construction, validation, and operational readiness of a new 503B Outsourcing Facility in Charleston, SC. This project involves the build-out of a modular cleanroom pharmaceutical manufacturing area, within an existing structure, to be compliant with U.S. FDA 503B regulations and current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Parts 210 and 211.

The Project Manager will oversee the full lifecycle of the facility build, including planning, vendor coordination, cleanroom installation, utilities integration, validation, regulatory readiness, and handoff to operations.

Key Responsibilities

Project Leadership & Execution

• Lead end-to-end execution of a modular cleanroom manufacturing and supporting structure area build.
• Develop and manage detailed project plans, budgets, schedules, and milestones.
• Coordinate cross-functional stakeholders including Engineering, Quality, Regulatory, Validation, Manufacturing, and Executive Leadership.
• Serve as the primary point of contact for contractors, cleanroom vendors, equipment suppliers, and consultants.
• Proactively identify risks and implement mitigation strategies to maintain timeline and budget.

Facility Design & Construction Oversight

• Oversee modular cleanroom design, fabrication, delivery, and installation.
• Ensure facility layout supports compliant workflows, material/personnel flows, and environmental controls.
• Coordinate mechanical, electrical, plumbing (MEP), HVAC, HEPA filtration, and critical utility systems (WFI, clean steam, compressed gases, etc.).
• Manage general contractors and subcontractors to ensure compliance with project specifications and cGMP requirements.

Regulatory & Compliance Alignment

• Ensure facility design and build align with Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable FDA guidance.
• Support readiness for FDA inspection and state Board of Pharmacy requirements.
• Collaborate with Quality and Validation teams to ensure proper documentation (URS, FS, DS, IQ/OQ/PQ protocols).
• Ensure adherence to cGMP standards and applicable USP chapters (e.g., USP , ).

Validation & Commissioning

• Oversee commissioning and qualification activities for cleanrooms and critical systems.
• Coordinate environmental monitoring setup and validation activities.
• Support process simulation activities for sterility assurance.
• Support development of SOPs related to facilities and equipment.
• Ensure successful facility turnover to Manufacturing and Quality teams.

Budget & Reporting

• Manage capital expenditure budget and vendor contracts.
• Track project performance metrics and provide regular executive-level updates.
• Ensure change control processes are followed for scope, schedule, and budget modifications.

Required Qualifications

• 7+ years of project management experience in pharmaceutical, biotech, or sterile compounding environments.
• Demonstrated experience leading construction or expansion of GMP-regulated manufacturing facilities.
• Direct experience with cleanroom builds (ISO 7/8 and higher classification preferred).
• Strong knowledge of FDA cGMP regulations and 503B outsourcing facility requirements.
• Experience managing modular construction projects preferred.
• Advanced proficiency with MS Project and/or other project management software.
• Proven ability to manage multi-vendor, cross-functional projects with aggressive timelines.
• Bachelor’s degree in Engineering, Construction Management, Life Sciences, or related field (PMP certification preferred).

Preferred Experience

• Prior experience building or remediating a 503B outsourcing facility.
• Experience preparing facilities for FDA inspection.
• Familiarity with Charleston, SC permitting and construction environment.
• Background in sterile injectable manufacturing.

Key Competencies

• Strong leadership and stakeholder management skills
• Excellent organizational and documentation practices
• Risk-based decision-making approach
• Detail-oriented with strong compliance mindset
• Ability to work on-site in Charleston, SC for critical phases

Deliverables

• Completed modular cleanroom facility delivered on time and within budget
• Fully commissioned and qualified GMP-compliant facility
• Inspection-ready documentation package
• Successful transition to operational manufacturing

This contract role offers a unique opportunity to lead the build of a state-of-the-art 503B modular pharmaceutical manufacturing facility from the ground up within an existing building. The ideal candidate thrives in complex, regulated environments and brings both construction execution expertise and deep GMP knowledge.

To apply, please submit your resume and a brief cover letter describing your relevant

At Clarest Health,we are dedicated to transforming patient care by providing innovative and efficient pharmacy services to healthcare facilities. Our commitment to excellence ensures that our automated dispensing solutions streamline medication management, improve patient outcomes, and enhance the overall efficiency of healthcare operations. As a part of the Clarest Health team, you'll be contributing to a mission-driven organization that is redefining the future of pharmacy services and making a meaningful impact on the lives of patients and healthcare professionals across the nation.

We’re seeking a Registered Nurse-level Field-Based Account Manager who takes initiative, solves problems proactively, and builds strong relationships. In this role, you’ll be the main link between our closed-door pharmacy and the long-term care communities we serve. You’ll ensure exceptional service through regular site visits, staff training, and smooth implementation of pharmacy technology, keeping communication clear between our pharmacy and client teams. If you’re motivated by connections, driven to improve outcomes, and committed to quality care, we’d love to hear from you.

Location: Field-Based – Massachusetts Region

Salary: Starting at $95,000+ per year

Schedule: Monday – Friday, Day Working Hours

Travel Requirement: 70% + (+Travel Reimbursement Provided)

Transportation: This role requires a valid driver's license and valid car insurance

Reports To: Account Management Leadership Team

What We Offer:

• Comprehensive Medical, Dental and Vision Insurance (as low as $13.73/pay)
• Free Virtual Care – Telemedicine
• Flexible Spending and Health Saving Accounts
• Substantial PTO Offering in Year One, with an Increase After Your First Year
• Travel Mileage Reimbursement
• 401k with company match
• Referral Bonuses
• Life Insurance
• Pet Insurance
• Legal Insurance
• Make a difference in the lives of others!
• We are growing and that means more opportunities

Key Responsibilities:

* Applicants must hold an active RN license and have relevant long-term care experience to be considered*

• Conduct regular site visits to monitor service quality, address client needs, and build strong relationships.
• Partner with facility and corporate leaders to ensure satisfaction, retention, and effective communication.
• Lead meetings, calls, and training sessions (virtual or on-site) to support staff education and share pharmacy updates.
• Oversee new facility onboarding and transitions, including setup, training, and operational support.
• Support adoption of pharmacy technology tools and troubleshoot issues as needed.
• Document visits, client interactions, and follow-up actions in line with company guidelines.
• Collaborate with pharmacy leadership and internal teams to resolve issues and maintain high service standards.
• Maintain compliance with Clarest’s Code of Conduct and all regulatory and reporting requirements.

Qualifications:

• Must have an active RN license in good standing
• Strong working knowledge of Long-Term Care operations and workflows required
• At least 3 years of relevant experience in Account Management (preferred)
• Must possess a valid driver’s license in good standing and active car insurance

Skills + Abilities:

• Must be able to communicate clearly and effectively, both verbally and in writing, with facility staff and internal teams
• Ability to motivate and lead teams, as well as develop and implement training materials for community/facility staff
• Demonstrated ability to identify issues, investigate concerns, and develop and implement solutions
• Strong customer service orientation with the ability to manage customer relationships, resolve complaints and ensure satisfaction
• Ability to lift up to 40 lbs., drive, and travel up to 70% of the time

Primus Pharmaceuticals is seeking a versatile Clinical Research Associate (CRA) to support the conduct of prescription medical foods clinical trials at a growing pharmaceutical company. This role offers a mix of remote monitoring, site activities, and in-office collaboration at our Scottsdale headquarters. This role is ideal for a professional who enjoys both hands-on site engagement and strategic oversight responsibilities in a fast-paced environment.

Primus is an innovative company with novel products based on unmet needs that empowers providers and patients with prescription brands that maintain the highest level of safety without compromising efficacy. We are scaling proven brands into their next chapter, and the ideal candidate will find this motivating and have the leadership and skills to drive results.

Position Overview

The CRA will collaborate closely with Primus, the vendors, and investigative sites to ensure high-quality, compliant study execution. This role requires effective communication, and the fostering of strong site relationships and operational excellence.

Roles & Responsibilities

Vendor & Site Oversight

• Provide operational oversight of monitoring activities, including the development of monitoring visit reports, follow-up letters, and issues escalation.
• Track site and vendor performance against key deliverables, KPIs, and study timelines.
• Review Trial Master File (TMF) content for accuracy and completeness.
• Contribute to study-specific documents, including monitoring, communication, and risk management plans.

In-Field & Site Monitoring

• Conduct qualification, initiation, interim monitoring, and close-out visits at investigational sites as needed.
• Verify informed consent documentation, source data, case report forms (CRFs), investigational product accountability, and protocol compliance.
• Identify and resolve protocol deviations, compliance issues, and data discrepancies directly with site personnel.
• Serve as the primary point of contact for assigned sites, building strong relationships with investigators and staff.
• Provide ongoing training and support to sites on protocol requirements, study tools, and GCP compliance.

Cross-Functional Support

• Collaborate with internal teams (Clinical Development, Regulatory, Data Management, Safety, Quality) to ensure aligned trial execution.
• Support the design, development, and refinement of essential clinical trial documents, including Case Report Forms (CRFs), monitoring plans, and study-specific instructional manuals.
• Support audit/inspection of readiness and contribute to corrective/preventive action (CAPA) planning.
• Assist in site and vendor governance meetings by providing operational feedback and insights.

Qualifications

Education & Experience

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field. (Requirement may be waived for candidates with 5+ years of directly relevant professional experience) .
• 3–6 years of clinical research experience, including at least 2 years as a CRA.
• Experience in both site/vendor oversight and direct site monitoring (pharma, biotech or CRO background preferred).

Technical Skills

• EDC Proficiency: Strong technical experience using Electronic Data Capture (EDC) platforms for data entry, query management, and source data verification (SDV).
• Platform Knowledge: Familiarity with industry-standard platforms such as Medidata Rave, Veeva Vault EDC, JotForm or Medrio.
• Compliance: Deep knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, and standard clinical trial processes.

General Skills

• Demonstrated ability to manage multiple sites/trials across various therapeutic areas.
• Excellent communication, organizational, and problem-solving skills.
• Willingness to travel (approximately 10–20%).
• Comfortable working in a smaller pharmaceutical setting with the flexibility to take on broad responsibilities.

About Primus Pharmaceuticals, Inc.

Primus innovates in prescription nutritional therapies targeting metabolic causes of chronic diseases across rheumatology, dermatology, and women’s health. We develop and commercialize first-in-class products and novel deliveries in Rx drugs, medical foods, and medical devices to fill key unmet needs with universal patient access not provided by traditional pharma. Visit our website at