THE POSITION:
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:
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
- Monitor study activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional polices.
- 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.
- All other duties assigned.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
EXPECTATIONS OF THE JOB:
- To understand, organize and archive clinical trial documents, including study protocols, SOP鈥檚, 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.
- Some travel may be required.
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.