Clinical Trial Assistant

Clinical Trial Assistant

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.

Essential duties and responsibilities include monitoring study activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies; maintaining required records of study activity including case report forms, drug dispensation records, and regulatory forms; ordering drugs or devices necessary for study completion; maintaining current knowledge of clinical studies affairs and issues by reviewing scientific literature, participating in continuing education activities, and attending conferences and seminars; preparing for and participating in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups; organizing space for study equipment and supplies; participating in the development of study protocols including guidelines for administration or data collection procedures; maintaining contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data; identifying protocol problems, informing investigators of problems, and assisting in problem resolution efforts such as protocol revisions; dispensing medical devices or drugs, and calculating dosages and providing instructions as necessary; and all other duties assigned.

Expectations of the job include understanding, organizing and archiving clinical trial documents, maintaining current lists of correspondence, administering clinical trials according to good clinical practices and standard operating procedures, providing general logistical support for clinical trials by entering subject and study site orders and arranging and confirming deliveries of study medications and supplies, and some travel may be required.

Minimum knowledge, skills, and abilities include a high school diploma/GED, 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, excellent written and verbal communication skills required, strong skills in MS Office programs i.e. EXCEL, WORD and PowerPoint, and current State of Missouri Pharmacy Technician Registration required.

Physical/mental demands and working environment include office environment where the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands.