Clinical Research Regulatory Specialist Oklahoma Medical Research Foundation
Provide clinical research operational support through management of IRB and regulatory documents.
1. IRB Correspondent. Ensure completion of IRB submissions for all trials including the IRB application, protocol, investigator's brochure, informed consent form, and HIPAA forms. Manage all other IRB submissions/ correspondence including continuing reviews/renewals, protocol amendments, ICF changes, protocol deviations, advertising approvals, and closure reports. Track and facilitate staff training/certifications pertaining to the IRB and regulatory requirements, particularly CITI, institution-specific training, GCP, and other study-specific training.
2. Regulatory Documents Manager. Ensure completion and submission of study start-up regulatory documents including protocol signature pages, 1572s, financial disclosure forms, CVs, and medical licenses. Maintain and update documents and logs as necessary throughout the course of the trials. Track and file all correspondence in study specific regulatory binders. Process and track all IND safety reports.
3. Staff Liaison. Collaborate with the study staff and the study sponsor at startup for completion of all required IRB and regulatory documents. Communicate with the investigators, clinical research coordinators, sponsor, and IRB regarding issues, questions, pending tasks, and status updates. Develop and implement processes to collect necessary information for management of IRB correspondence and reporting, i.e. enrollment status for continuing review forms, unanticipated adverse events log
4. As Needed. Performs various duties as needed to successfully fulfill the function of the position.
Bachelor's Degree and relevant experience in regulatory affairs and clinical research or equivalent experience, medical/science background and/or relevant experience, excellent knowledge of all relevant regulations including ICH, GCP, and FDA CFR as applicable. Will accept 48 months of equivalent experience in lieu of a Bachelor's degree.
Founded in 1946, the Oklahoma Medical Research Foundation is one of the nation’s oldest and most respected nonprofit biomedical research institutes. Located in Oklahoma City, OMRF fosters a worldwide reputation for excellence by following an innovative cross-disciplinary approach to medical research.
OMRF scientists are dedicated to understanding and developing more effective treatments for hum...an disease, focusing on such critical research areas as heart disease, cancer, lupus and Alzheimer’s disease. With more than 700 U.S. and international patents, OMRF ranks among the nation’s leaders in patents per scientist.