Clinical Trial Assistant

Job Description

The Clinical Trial Assistant (CTA) supports clinical trials by maintaining organized files, performing pharmacy technician duties, communicating routinely with trial sites, coordinators, and patients while demonstrating good clinical practices and following standard operating procedures. Clinical trials are designed to test new medications and medical devices for safety and efficacy. Trials are highly regulated and thoroughly monitored, which results in a significant record‑keeping and a compliance burden.

• Monitor study activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies.
• Maintain required records of study activity including case report forms, drug dispensation records, and regulatory forms.
• Order drugs or devices necessary for study completion.
• Maintain current knowledge of clinical studies affairs and issues by reviewing scientific literature, participating in continuing education activities, and attending conferences and seminars.
• Prepare for and participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Organize space for study equipment and supplies.
• Participate in the development of study protocols including guidelines for administration or data collection procedures.
• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
• Identify protocol problems, inform investigators of problems, and assist in problem resolution efforts such as protocol revisions.
• Dispense medical devices or drugs and calculate dosages and provide instructions as necessary.
• Successful fulfillment and delivery of all prescriptions and supplies to patients in a timely manner.
• Management of medication and supply inventory.
• Positive patient and client experience throughout the entire patient journey.
• All other duties as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

• To understand, organize and archive clinical trial documents, including study protocols, SOP’s, Resource Documents, dispensing and manufacturing records, email correspondence, training materials and other study documents.
• Maintain currents lists of correspondence.
• Administer clinical trials according to good clinical practices and standard operating procedures.
• Provide general logistical support for clinical trials by entering subject and study site orders and arranging and confirming deliveries of study medications and supplies.
• Pick and pack patient prescriptions, wholesale orders and supply orders.
• Inspect on‑hand inventory for integrity, purity and appropriate expiration dating.
• Ensure all manufacturer program specific literature and materials are included in shipments as necessary.
• Create and ensure appropriate third party shipping labels are attached to all patient prescriptions, wholesale orders and supply orders.
• Restock medication, supply and ancillary products upon receipt.
• Keep all medications and ancillary supplies organized, rotated by expiration date and sorted by lot number.
• Assist with shipment status modification (i.e. hold, return‑to‑stock).
• Participate in all medication and supply inventories as assigned.
• Compliance with all applicable state and federal pharmacy laws.
• Some travel may be required.
• Hours (40 hours per week, 5 days of the week).

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

An individual in this position must be able to successfully perform the expectations listed above.

• Associate’s degree in the health sciences, biological science, or other life sciences.
• Prior work experience in healthcare or life sciences; clinical trial experience preferred.
• Meticulous attention to detail and a demonstrated willingness to complete routine administrative tasks.
• Ability to work in a team environment.
• Ex…