This position is responsible for assisting the Administrative Research Core with preparing, organizing, and filing documents related to clinical research protocols, including Institutional Review Board (IRB) documents. This position will be responsible for the accurate organization of regulatory files for the Department of Obstetrics and Gynecology. Candidate must be a graduate student.

• Assists with the preparation of regulatory documents for IRB submissions for OB/GYN investigators.
• Assist in developing clear and accurate subject informed consent documents and HIPAA authorization documents for investigators with close oversight from the Research Services Manager.
• Assists in maintaining a comprehensive record keeping system of regulatory requests at the direction of the Research Services Manager.
• Assists in maintaining regulatory document e-files for each clinical research protocol.
• Performs quality assurance reviews of shared study files and relays findings to Research Services Manager.
• Assists the Research Services Manager with developing general research policies and procedures relating to clinical research.
• Other duties as assigned.