JOB SUMMARY

The Research Regulatory Associate I supports clinical research activities through the development of protocol-specific documents and reports for research activities from initial submission through study closure. The primary focus for this position is on the development, submission, maintenance, filing, archival, and reporting of regulatory documents to achieve and maintain compliance with all internal, external, and federal policies and regulations involving the research of human participants. In addition, this position also provides regulatory guidance and direction to internal clinical research programs and staff to ensure compliance with all applicable policies, procedures, and regulations.

DUTIES AND ESSENTIAL JOB FUNCTIONS

• Prepares, facilitates, and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy.
• Ensures that the research site follows standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices pertaining to the conduct of clinical pharmaceutical and device protocols.
• Safeguards prior to sending to the IRB that all documents are complete and that the submission packet meets the IRB's submission requirements.
• Maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures.
• Responses and assists with queries from the IRB, Sponsor, and other committees.
• Produces error-free written documents and reports, such as cover letters, notes-to-file, and memos.
• Obtains the Sponsor's approval for the consent form prior to submission to the IRB.
• Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research.
• Facilitates and coordinates the timely and accurate submission of regulatory documents (hard copies and electronic binders) and IRB submissions by collaborating with research nurses, clinical research coordinators, and investigators to prepare regulatory documents.
• Accurately files and maintains all necessary logs within the regulatory binder(s), assists in and manages the archival of clinical trial documents/records. Tracks workload and status of pending protocols and associated supporting documents to provide efficient customer service to the Research team.
• Interacts with internal and external personnel, including but not limited to physicians, nurses, research staff members, administration staff, industry sponsor representatives, IRBs, central laboratory/imaging personnel, and clinical trial patients, and attends site initiation visits. Oversees the QA initiatives for the department to support research staff and leaders during Sponsor and FDA audits.
• Ensures all regulatory requirements are met, including requirements for trial registration, results, and reporting in a timely manner consistent with federal regulations.
• Coordinates multiple projects with competing priorities and deadlines, as needed, based on clinical trial protocol directives and study volume.
• Assists with all other duties as assigned