The Regulatory Affairs Associate works to support the Office of Clinical Research, and associated investigators and study teams. The Regulatory Affairs Associate is responsible for coordinating the regulatory and administrative requirements for conducting research, and will primarily be assigned to assist in regulatory management of multi-faceted, complex investigator-initiated treatment protocols. The role is expected to interface with other academic centers, NIH funded consortia, the Federal Drug Administration (FDA), and industry sponsors on highly sensitive and confidential projects. This position supports all aspects of regulatory compliance for a specified portfolio of clinical trials. 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.
This role is located at the McNair Campus.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 agencies inquiries or comments
- Communicates with central and local IRBs, CROs, sponsors and PI's related to new protocols and protocol amendments
- Compiles and maintains regulatory documentation electronically and in investigator site files
- Maintains OCR regulatory database
- Assists with and prepares for FDA meetings, inspections, and audits from regulatory agencies
- Prepares regulatory reports and coordinate data collection and reporting with other departments
- Tracks changes in regulatory guidelines as they may occur
- Prepares updates on laws, regulations and guidelines for distribution to appropriate study personnel and investigators
- Maintains working knowledge of regulatory changes through guidelines, articles, writings and courses
- Supports PIs and study staff by assisting in the data collection and notification required for reporting of Adverse Events
- Facilitates communication with IRB related to Adverse Events
- Supports study monitoring, as needed and requested
- Assists with regulatory affairs training
- Assists Investigators with assurance with ClinicalTrials.gov and funding entity requirements
- 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.