Job Details

Title: Clinical Research Regulatory Specialist
Company: Oklahoma Medical Research Foundation
Location: Oklahoma City, OK

The Arthritis & Clinical Immunology Research Program is hiring for a Clinical Research Regulatory Specialist. This position will provide clinical research operational support through management of IRB, CDAs, MTAs and other regulatory documents.

- IRB Correspondent: Ensure completion of IRB submissions for all trials; 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 IRB training/certifications pertaining the requirements, particularly CITI, institution-specific training, GCP, and other study-specific training.

- 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.

- Staff Liaison: Collaborate with the study staff and the study sponsor at start up for completion of all required IRB and regulatory documents. Communicate with team regarding issues, questions, pending tasks, and status updates. Develop and implement processes to collect necessary information for management of IRB correspondence and reporting.

Minimum Qualifications:

  • Bachelor's degree
  • Experience in regulatory affairs and clinical research, medical/science background and/or relevant experience, knowledge of all relevant regulations including ICH, GCP, and FDA CFR.

To apply for this position or to learn more, please click "Apply Online" below.

SOCRA Exp: 2/12/2022