General Responsibilities

To serve as a liaison with medical staff, University Departments, ancillary departments and/or satellite facilities. To organize patient enrollment planning. To conduct quality assurance activities. To compile and analyze data. To develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected. To serve as a mentor to junior staff, including student assistants.

Key Duties & Responsibilities

1. Serves as a liaison with medical staff, University Departments, ancillary departments and/or satellite facilities. Organizes patient enrollment planning. Conducts quality assurance activities. Compiles and analyzes data. Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
2. Coordinates patient care and/or patient follow-up functions of the clinical study including planning and developing related activities. Arranges access to study medications, including authorization for prescriptions. Employs strategies to maintain recruitment and retention rates.
3. Prepares and submits multiple levels of research documentation (i.e. IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).
4. Manages investigational products (IP). Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.
5. In conjunction with Investigators, plans and implements the clinical protocol’s goals and objectives. Compiles, edits and proofs written reports for both internal and external administrative offices. Provides data for the creation of study budgets as needed.
6. Completes Case Report Forms (CRF) according to protocol. Assists with development of standard operating procedures (SOPs) for data quality assurance.
7. Performs vendor analysis and equipment configuration as needed. May perform a variety of medical procedures.
8. Under the oversight of the Investigator, develops protocols, identified efficiencies and improves processes. Serves as a mentor to junior staff, including student assistants. Arranges multidisciplinary evaluations.
9. Maintains compliance with federal, state and accrediting agencies (sponsors). Maintains any required documentation.
10. Processes and maintains lab specimens.
11. Manages site supplies as needed.
12. Serves as a mentor to junior staff, including student assistants.
13. Performs other duties as assigned.