Regulatory Affairs Associate

Summary

The Department of Surgery Core at Baylor College of Medicine, Houston, Texas, is seeking a Regulatory Affairs Associate to support the Office of Surgical Research, associated investigators, and study teams. The Regulatory Affairs Associate is responsible for coordinating the regulatory and administrative requirements for conducting research and assisting in the management of multi-faceted, complex investigator-initiated treatment protocols and industry-sponsored protocols. This position supports all aspects of regulatory compliance for a specified portfolio of clinical trials. This support includes reviewing protocols and protocol-related documents, submitting protocols to regulatory agencies and review committees, ensuring successful navigation of the approval processes for clinical research, and other regulatory-related activities.

Job Duties

• Manages clinical study regulatory work for multiple research studies and/or clinical trials.
• May assist with regulatory affairs training.
• May assist with IND/IDE submission and reporting to the FDA and other government agencies.
• Communicates with IRBs and PIs related to submissions, renewals, and adverse events.
• Creates regulatory reports as needed/requested.
• Serves as main contact for investigators, sponsors, government agencies, and the IRB.
• Responsible for regulatory oversight and compliance of the project to include drafting reports to the FDA and other regulatory bodies.
• Communicates with the IRB related to submissions, renewals, and adverse events.
• Responsible for operational oversight of the project to include creating and monitoring timelines and keeping the project compliant and on track.
• May assist with research coordination as needed.

Minimum Qualifications

• Education Required: Bachelor's degree.
• Experience Required: Two years of relevant experience.
• Certification/Licenses/Registration: None Required.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

5067

CA; CH