Research Compliance Specialist

About Us:

The Office of Clinical Research supports the research community by ensuring completion of all applicable institutional components/approvals for human research.  Assists with External IRB applications.

 

Job Summary:

Under direct supervision, responsible for facilitating clinical research, interfacing with staff and departments, and participating in education and training efforts. Work resides in the Office of Clinical Research (OCR) reporting to the OCR Manager. Interfaces extensively with the OCR, IRB, IACP, CTO staff and other departments. 

 

Job Duties:

1. Conducts highly competent review of research applications to assess risks to the institution and identify the regulatory and institutional policy requirements. Communicates training requirements and Research Scope of Practice requirements to research staff as they relate to specific protocols and verifies requirements are satisfied prior to issuing institutional approvals for research implementation.

2. Coordinates with affiliated institutions, clinical departments, other institutional committees and departments to facilitate institutional approvals to achieve rapid enrollment of participants into clinical research trials.

3. Processes incoming business items to ensure necessary documents are present and items are placed into the workflow for appropriate and timely review.

4. Communicates the outcomes of the reviews to the investigators and institutions. Maintains accurate documentation of all actions and determinations made related to the research studies.

5. Provides advice and assistance to investigators, committee members, office staff, and research staff regarding procedural requirements for submitting research materials and documents to ensure compliance to the applicable regulations and policies.

 

Job Type: Full-time

 

Education/Experience:

Associate’s degree in Clinical Research, Research Administration, or related field or two (2) years of experience in research administration is required.

 

Additional Information