Advanced Research Institute has an immediate opening for a Regulatory Coordinator position. The Regulatory Coordinator develops and coordinates the submission of regulatory documents to ensure compliance with all governing requirements. Supports the Principal Investigator and study team ensuring compliance with the IRB, site SOP’s, state, and federal regulations that govern clinical research. Prepares and maintains all regulatory documents as well as submissions to the Institutional Review Board (IRB) including but not limited to: initial IRB submissions, changes in research or site information, safety and deviation reporting, IRB closures. The Regulatory Coordinator will also maintain and accurately file all study related documents within electronic regulatory system as well as paper binders.
Responsibilities:
- Supports all aspects of regulatory compliance. Prepares, facilitates, submits and maintains the process for accurate and timely submission of IRB applications for study start-up, protocol revisions or amendments, administrative changes, changes in subject population, funding, recruitment procedures, site changes, and changes in informed consent.
- Completes, audits, and maintains study records, materials, and databases to ensure compliance with study protocols, FDA, IRB, and site SOP’s.
- Prepares regulatory documents and obtains signatures for FDA 1572’s, Financial Disclosure Forms, Protocol Signature pages, IB acknowledgment of Receipts, Delegation Logs, Training Documents, and other forms.
- Files all correspondence and other important documents in the electronic regulatory system as well as paper-based regulatory binders.
- Communicates with research staff, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
- Tracks study approvals and expirations to ensure uninterrupted project approval.
- Submits study renewal applications and study progress reports to the IRB.
- Coordinates with study sponsor, investigator, and IRB to complete all study activities from study start-up to study closure.
- Assists investigators and others involved in clinical research with process and policy issues and provides guidance.
- Recommends and implements regulatory process improvements.
- Maintains current knowledge of federal and institutional guidelines and requirements governing research.
- Demonstrates initiative, enthusiasm, positive attitude, teamwork, and commitment to the research mission of Advanced Research Institute.
Disclaimer
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Job Type/Work Environment:
Full Time. Office environment.
Minimum Qualifications:
One year of regulatory experience with Industry-Sponsored clinical trials is preferred. Current training, certifications, and/or degrees in the field of human research protections is preferred.
Job Type: Full-time
Pay: $20.00 - $26.00 per hour
Benefits:
- 401(k) matching
- Flexible spending account
- Health insurance
- Paid time off
Work Location: In person
