Clinical Research Pharmacist

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 #J-18808-Ljbffr