This position provides hands-on experience in the preparation, documentation, and management of investigational products for clinical trials. The intern will work under the direct supervision of a licensed pharmacist to support study start-up, dispensing, inventory, and documentation processes, while gaining exposure to community-engaged clinical research. Essential Duties and Responsibilities Essential and other important responsibilities and duties may include but are not limited to the following: Study Start-Up & Documentation: Assist in the development, preparation, and maintenance of protocol-specific documents, including: Compounding worksheets Drug accountability logs Patient medication diaries Dosing instructions Visit-specific medication handouts or counseling sheets Format and print protocol materials for staff and participants; maintain document version control. Support setup of study binders, electronic files, and documentation templates for each trial. Dispensing & Inventory: Assist in the preparation, labeling, and dispensing of investigational drugs per protocol and Good Clinical Practice (GCP) guidelines. Help manage inventory tracking, including receiving study drug shipments, logging lot numbers, expiration dates, and storage conditions. Monitor refrigerator/freezer logs and report temperature excursions promptly. Reconcile drug inventory and assist with preparing drug return or destruction forms. Participant & Study Support: Provide study participants with protocol-specific medication instructions and review diary completion processes under pharmacist supervision. Communicate with clinical coordinators and nurses regarding drug availability and dosing schedules. Assist in packaging take-home medication kits for participants in compliance with study requirements. Regulatory Compliance: Maintain accurate, real-time documentation for investigational drug accountability. Support compliance with FDA, IRB, sponsor, and Virginia Board of Pharmacy regulations. Participate in internal audits and assist with documentation for sponsor monitoring visits.
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Career Level
Intern
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees