The Regulatory Affairs Associate supports the Office of Clinical Research, and associate investigators and study teams by coordinating the regulatory and administrative requirements for conducting research. The role is expected to interface with other academic centers, NIH funded consortia, the US Food and Drug Administration (FDA), and industry sponsors on highly sensitive and confidential projects. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees, and ensuring successful navigation of approval processes for clinical research. This position requires expertise and understanding of multiple therapeutic indications and applicable regulations.Job Duties
- Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, and follow-up of submissions under review.
- Coordinates the planning, preparation, data collection, assembly, review and publication of regulatory submissions to the FDA and other government agencies.
- Reports and responds to agency inquiries or comments.
- Assists with and prepares for FDA meetings, inspections, and audits from regulatory agencies.
- Assists in preparation of research protocols for IRB submission, submitting protocol amendments, preparing renewals, preparing necessary regulatory documents for submission to study sponsors, submits adverse event reports, submits safety reports, and notifies IRB of study closures.
- Ensures timely communication between IRB, regulatory agencies, study team and PIs regarding status of regulatory and/or important safety related issues, to ensure that protocols are approved and that supplementary information is provided in a timely fashion as requested.
- Provides regulatory reports and routine updates to OCR management team and PIs, and coordinate data collection and reporting with other departments.
- Support PIs and study staff by assisting tin the data collection and notification required for reporting of Adverse Events, and facilitates communication with IRB related to Adverse Events.
- Maintains the required regulatory files for all assigned clinical trials to ensure regulatory compliance.
- Supports study monitoring, as needed and requested. Maintain archived documents on and off site.
- Maintains working knowledge of regulatory changes through guidelines, articles, writings and courses, and prepares updates on laws, regulations and guidelines for distribution to appropriate study personnel and investigators.
- Assists with regulatory affairs training.
- Assists PIs with providing registration and assurances support to ClinicalTrials.gov processes; administrative support for IND-IDE service requests; and interacting with FDA and other regulatory agencies.
- Assists with development and implementation of regulatory skillset trainings across the College.
- Participates in additional projects as directed by research management as a central office within the Office of Research.
- Provides cross-coverage across OCR clinical research study support as needed.
- Provides regulatory affairs support for clinical trial service requests received in the OCR for study support across the College.
- Assists in regulatory skillset trainings across the College.
- Bachelor's degree.
- Two years of relevant experience.
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
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