Job Description
Position Title: Regulatory Affairs Associate I
Department: Shared Services - USA Regulatory Affairs Reports To: Network Director, Regulatory Affairs Tasks and Responsibilities: - Prepare and submit study documents to the IRB for assigned studies. This includes, but is not limited to, revised protocols, revised investigators brochures, protocol clarification letters/memos, revised informed consents (ICs), new ICs, continuing review reports, closure reports, serious adverse events, IND safety reports, unanticipated problems, protocol deviations, and waivers. Serve as the main point of contact with the IRB regarding those studies. Enter all submission dates in FileMaker database, note pending information and generate status reports as required. Respond to inquiries and follow up, as required, on pending items.
- Maintain Investigator Site File (ISF) (paper and/or electronic). This includes, but is not limited to, IRB submissions, IRB approvals, study documents, and study correspondence.
- Process serious adverse events (SAEs) as assigned
- Prepare and manage Close-out Visits for assigned studies.
- Complete and obtain signatures on essential documents (Form FDA 1572s, Protocols, Amendments, Investigators Brochures, and Financial Disclosure Forms, etc.) from appropriate personnel for assigned studies and send initial regulatory packet to Sponsor/CRO (signed signature pages, signed 1572, CVs, licenses, laboratory certifications, normal ranges, etc.) for assigned studies.
- Ensure that study documents are received before each SIV for assigned studies. Distribute documents to the study team before each SIV and file documents in ISF for assigned studies.
- Onboard new studies to electronic ISF. This includes, assigning Investigators, IRB(s), Lab(s), Study Drug(s).
- Maintain IRB Membership Rosters and update ISFs as needed.
- Attend weekly Phase I meeting. Follow-up with the appropriate department(s) and/or the Sponsor/CRO to address any regulatory issues raised during these meetings.
- Attend Site Initiation Visit meetings for assigned studies. Follow-up with the appropriate department(s) and/or the Sponsor/CRO to address any regulatory issues raised during these meetings.
- Share responsibility with other Regulatory Affairs staff to handle and be available for monitor visits. This includes, but is not limited to giving the monitor access to the ISF, ensuring the monitor signs the Monitor Visit Log, if applicable, being available to assist the monitor, and noting monitor changes in FileMaker.
- Share responsibility with other Regulatory Affairs staff to stamp and distribute all incoming departmental mail as needed.
- Perform other duties as assigned.
Preferred Educational Requirements: Bachelors degree.
Experience Requirements: Three to five years experience in a regulatory research setting. Proficient working knowledge of Microsoft Word. Must possess strong organizational skills and a sense of timeliness in completing projects, be detail-oriented, and have good spelling, composition and proofreading skills. Able to complete tasks with minimal supervision, understand instructions, compose reports and correspondence.
FLSA : Non-Exempt
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