Clinical Research Pharmacist

ECN Operating LLC; Sun City West (AZ); On-site; USD 83,000 - 131,000; Full time

Job summary

Elite Clinical Network in the United States seeks a Clinical Research Pharmacist PRN to manage investigational product operations for complex trials, ensuring compliance with GCP, FDA, and USP standards. The role collaborates with the Site Director, investigators, and study staff to support safe and ethical research.

Responsibilities include IP preparation and dispensing, sterile compounding, adherence to blinding plans, IP logging, and IRB/audit readiness, with travel to sites for dosing and

Qualifications

• Doctor of Pharmacy or PharmD degree.
• Active unrestricted Pharmacist license in the state of practice.
• Current IATA Certification for shipping dangerous goods or willingness to obtain within 30 days of hire.
• Minimum 12 years of hospital or compounding pharmacy experience.
• Prior Clinical Research experience handling IP blinding and protocol specific compounding is preferred.
• Experience with USP sterile compounding standards and USP hazardous drug handling.

Responsibilities

• Investigational Product (IP) Preparation and dispensing of IV infusions, subcutaneous injections, and oral meds per study protocol and Pharmacy Manual.
• Maintain sterile environment and aseptic technique for IP preparation.
• Adhere to Blinding plans and protect IP information to prevent unblinding.
• Manage IVRS/IWRS systems for subject randomization, kit assignment, and inventory.
• Maintain IP Accountability Logs ensuring traceability of all dispensed, returned, and destroyed product.
• Oversee IP inventory across ambient and controlled temperatures and monitor temperature excursions.
• Support monitoring visits and audits by CRAs; prepare pharmacy binders and regulatory documentation.

Skills

Pharmacist license

IATA

Clinical research experience

USP standards

HIPAA

Detail oriented

Communication

Education

Doctor of Pharmacy (PharmD)

Job description

Position Summary The Clinical Research Pharmacist PRN is responsible for managing and coordinating the investigational product IP operations for clinical research studies requiring complex preparation or aseptic technique This role ensures that pharmacy research activities are conducted in compliance with regulatory requirements study protocols Good Clinical Practice GCP guidelines and USP standards The Pharmacist works closely with the Site Director investigators and blindedunblinded study staff to support high quality safe and ethical research

Key Responsibilities

• Investigational Product IP Preparation
• Prepare compound and dispense IV infusions subcutaneous injections and oral medications in strict accordance with the study protocol and Pharmacy ManualSterile Compounding USP
• Maintain a sterile environment for preparing sterile compounds and apply rigorous aseptic techniques to prevent contamination and ensure patient safety
• Protocol & Blinding Adherence Execute the site specific Blinding Plan for randomized trials Ensure that unblinded IP information eg assignment preparation details is handled strictly in accordance with protocol to prevent unblinding of study staff or participants
• IVRS/IWRS Management Navigate web based Interactive Response Technology IRT systems for subject randomization kit assignment and inventory management
• Accountability & Documentation Maintain accurate IP Accountability Logs to ensure 100 traceability of all dispensed returned and destroyed product
• Inventory Management Oversee receipt and storage across various conditions Ambient 2 8C 20C 80C Monitor continuous temperature logs and lead the resolutionreporting of temperature excursions
• Monitor Visits Meet with Clinical Research Associates CRAs during monitoring visits to review pharmacy binders drug accountability records and resolve queries
• Support Audit Readiness Maintain and organize pharmacy regulatory binders and study documentation in compliance with FDA GCP and Sponsor requirements

Qualifications

• Education Doctor of Pharmacy PharmD degree required
• Active unrestricted Pharmacist license in the state of practice
• Current IATA Certification for shipping dangerous goods or willingness to obtain within 30 days of hire
• Experience Minimum 12 years of hospital or compounding pharmacy experience required
• Prior Clinical Research experience handling IP blinding and protocol specific compounding is highly preferred
• Experience with USP sterile compounding standards and USP hazardous drug handling

Skills

• USP Proficiency Demonstrated knowledge of sterile compounding and aseptic technique
• IVRS/IWRS Familiarity with randomization portals and inventory management systems
• Mastery of Body Surface Area BSA weight based dosing and complex dilution factors
• Strong attention to detail and organizational skills
• Excellent communication and interpersonal skills
• Familiarity with HIPAA and human subject protection regulations

Schedule

PRN as needed Shifts are driven by patient enrollment randomization schedules and infusion windows May involve direct patient interaction during dosing or administration Must be willing to travel to the site for scheduled dosing visits and monitoring visits.

Physical Requirements

• Ability to stand walk sit use hands and reach with arms.
• Ability to lift up to 25 pounds occasionally.
• Ability to wear personal protective equipment PPE for extended periods while working in the compounding hood.

Equal Opportunity Employer Elite Clinical Network is an equal opportunity employer and does not discriminate on the basis of race color religion gender gender identity sexual orientation national origin disability age or veteran status