Scheduled Hours

40

Position Summary

Clinical research is a heavily regulated field. It is regulated at the federal level by the Department of Health and Human Services, Office of Human Research Protections, the Food and Drug Administration, the Office of Civil Rights, to name a few. There are state and local rules, regulations and statutes that may impact the conduct of clinical research. In addition, institutional policies from the University, School of Medicine and the Division also come into play. The regulatory coordinator’s responsibilities are to keep the studies’ regulatory statuses up-to-date, obtain necessary information to submit to the IRB and other regulatory bodies to maintain compliance with various rules, laws, regulations and policies at each stage of a clinical study.

Job Description

Primary Duties & Responsibilities:

• Writes and prepares Institutional Review Board (IRB) regulatory submissions, including, but not limited to, consent forms, new project applications, amendments, continuing review application, exceptions, and promptly reportable information.
• Coordinates submissions to ancillary committees such a Protocol Review and Monitoring Committee, Radioactive Drug Research Committee, and Institutional Biological and Chemical (IBC) Safety Committee.
• Maintains accurate records related to the regulatory aspects of research to ensure that regulatory files are audit-ready. Resolves monitoring and auditing issues with regulatory files.
• Maintains compliance with regulatory requirements and institutional policies.
• Serves as the primary regulatory contact for studies and collaborates with study investigators, study coordinators, sponsors, and Clinical Research Organization (CRO) to coordinate study start-up activities and ongoing regulatory activities throughout the life of the trial.
• May coordinate timely investigator assessment of safety reports.
• Proactively identifies regulatory issues and recommends process improvements in conjunction with a peer or supervisor.
• Keeps up to date on regulations and guidelines pertaining to clinical trial research.
• Serve as a regulatory information (federal, state, institutional) resource for faculty and research staff, and as the communication and strategic interface between faculty investigators and institutional review board(s).
• May maintain essential documents in audit ready order.
  • Delegation of duty logs
  • Site visit logs
  • Signed protocol and investigational product documents
  • Study specific regulatory materials
• Collects and maintains research staff CVs, Human Subjects and Good Clinical Practice Training records, professional licenses and various study related certifications.
• Collects and maintains CAP, CLIA, CVs lab normal from laboratories and other facilities used for research.
• Develop, prepare, submit, and maintain as needed, annual safety reports for clinical studies, including but not limited to DSMB reports, and inclusion and enrollment tables for grants.
• May develop, prepare, and submit, in collaboration with investigators, FDA Investigational New Drug (IND) applications and Investigational Device Exemption (IDE) applications, and communicate with FDA as appropriate and requested by PIs.
• May develop, prepare, submit, and maintain annually or as needed, clinical study registration materials for Clinicaltrials.gov.
• Performs other duties incidental to the work described above.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education:

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications:

No specific certification is required for this position.

Work Experience:

No specific work experience is required for this position.

Skills:

Not Applicable

Driver's License:

A driver's license is not required for this position.

More About This Job

Required Qualifications:

• (Optional Based on Department) SOCRA/ACRP certification.