The Cancer Clinical Research Program has an outstanding opportunity for a full-time Clinical Research Regulatory Coordinator. This position will support the conduct of Clinical Research in the Hematology/Oncology, Radiation Oncology, and Surgical Oncology departments by supporting the regulatory aspects of Phase I-IV clinical trials. The Regulatory Coordinator will need to understand the research protocols and translate research needs into appropriate regulatory requirements and has the responsibility for ensuring the clinical trials conducted by the Cancer Clinical Research Program meet regulatory requirements and are compliant with federal and institutional policies.
A Clinical Research Regulatory Coordinator (CRRC) performs tasks to facilitate regulatory aspects of clinical research, especially activities concerning Institutional Review Board (IRB) reporting, supporting Sponsor regulatory activities such as IRB submissions, training logs, and collection of regulatory documents including GCP/Ethics, CVs, Medical Licenses and Amendments (e.g., Protocol, Investigator Brochure, Consent). May also assist clinical research team with study preparation, preparation for study monitor visits, and ensuring site adherence to regulatory guidelines.
The Clinical Research Regulatory Coordinator will need to understand the research protocols and translate research needs into appropriate regulatory requirements. This will require integration of information from multiple sources and use of specialized regulatory knowledge of the governing clinical research policies, to ensure all clinical trials are compliant with applicable federal and institutional regulations and comply with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), Good Clinical Practices (GCPs) and International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA) and institutional policies and procedures
• Submit and track all regulatory submissions to internal and external IRBs and other governing bodies, including Institutional Biosafety Committee.
• Assist with Clinical Research Feasibility review.
• Complete and submit appropriate IRB documents including initial applications, Continuing Reviews, modifications to existing studies, Safety Reports, and protocol deviations while assisting with maintenance of regulatory files/binders
• Obtain and work with the Clinical Research Coordinator on reviewing and submitting study amendments, e.g., protocol, investigator brochure, consent. Ensure any changes to these documents are reflected in the Source documents, training logs, and Clinical Trial Management software.
• Maintain supporting study documents e.g., study training logs, collection of regulatory documents, GCP/Ethics, CVs and Medical Licenses.
• Support communication with sponsor and team, schedule monitor visits as needed and complete sponsor required regulatory duties in preparation for study monitor visits.
• Provide manager with timely reporting of roadblocks and challenges that arise in adherence to clinical research regulatory requirements.
• Assist with process improvement projects.
• Submit closure report to IRB upon closeout visit or notification with the sponsor.
• Attend sponsor and site initiation meetings as necessary.
• Attend regular meetings with the Principal Investigator as requested.
• Communicate and work with internal and external staff regarding VM/BRI, sponsor or FDA audits or other investigations.
• Perform other duties as assigned.
This position works with varying levels of direction in performing recurring work assignments that occasionally vary from the norm. Although the position operates from established and well-known procedures, there is a moderate degree of complexity expected due to the number of studies and type of documents and processes that must be coordinated simultaneously. Impact can extend to results of research projects if FDA and GCP Guidelines are not carefully followed.
This position does not work with patients or study participants directly.
Requires knowledge of IRB submission procedures, FDA and NIH requirements relating to research involving human subjects and experience using electronic data submission software. Also requires strong computer skills, sound decision-making skills, ability to multi-task and meet deadlines, work independently, effective communication and interpersonal skills, along with strong organizational ability.
Requires completion of: 1) Human Subjects Research Training tutorial and classes; 2) Ethical Human Research training; and 3) shipping and handling of hazardous materials training provided by BRI.
Prefer Bachelor’s degree and at least 1 year of experience in clinical research or IRB operations.