COORDINATOR PROTOCOL SERVICES

Essential Job Functions:

Identify and recruit patients into a clinical research protocol guidelines. Evaluate potential candidates based on research criteria; collect data from family/medical history of patient; record all data pertinent to the research and care of the patients. Monitor patient compliance with protocol.

Organize and maintain recruitment files and volunteer/subject files, and maintain strict standards for accurate and organized documentation of research activity.  Enter research data into case report forms and electronic data capture systems.  Check data for accuracy.  Assist in the maintenance of the clinical data base, including chart retrieval and review. Maintain proficiency with various data capture/research and analytics platforms.

Coordinate testing services and schedule research study evaluations/visits.  Assist with referral of subjects as needed.

Work with the division administrator and with Hospital/University Physicians billing departments to ensure correct charges for clinical services and other project expenses.  Itemize budget requirements; assist with monitoring and reconciliation of budget. 

Collect and process research specimens in adherence with environmental health and safety protocols, review inventory of research supplies and check for expiration dates on a regular basis. Perform study required vital signs, specimen collection and processing, and any other study required procedures. Training will be provided on specific study related procedures. Assure research subject and staff safety at all times

Contribute to a positive, efficient, professional, and highly skilled research work environment. Initiate and engage in consistent communication and collaboration with clinic and department personnel and research leadership.

Create and maintain regulatory documentation and ensure regulatory compliance by research team. Complete IRB applications, amendments, personnel change forms, continuing review reports, and other study required documents.  Complete clinical trial regulatory documents.

Acquire and use knowledge of institutional and federal regulations and guidelines related to research. Maintain compliance with Institutional and CITI training.