Manages and oversees regulatory activities supporting clinical research studies across the Center for Research Advancement (CRA). Provides leadership and direction to regulatory staff, ensuring timely and compliant submission of regulatory documents to institutional, federal, and sponsor entities. Serves as a subject matter expert, interpreting complex regulatory requirements and advising investigators and research teams. Operates with a high degree of autonomy and professional judgment to ensure regulatory compliance, audit readiness, and successful study execution across a diverse clinical portfolio. Supports CRA Regulatory operations across a large and complex clinical research portfolio. Works in close coordination with Clinical Trial Finance, QA/QC, and Research Administration to ensure alignment between regulatory compliance, study activation, and downstream financial processes. Partners with the Protocol Development/IND team as needed to ensure appropriate delineation of responsibilities.
Position is a hybrid role typically working two days a week in office after initial training and onboarding is completed. Office hours are 8-5pm (+/-1hr) to align with clinical operations.
Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.
Job DutiesRegulatory Oversight and Study Lifecycle Management (25%)
- Manages regulatory activities across the full clinical trial lifecycle, including study start-up, maintenance, amendments, and close-out.
- Oversees preparation, review, and submission of IRB and sponsor documentation, including amendments, continuing reviews, and safety reporting. Ensures all studies meet regulatory requirements and internal timelines, supporting a portfolio of complex, multi-site clinical trials.
Staff Supervision, Leadership, and Work Allocation (20%)
- Directly supervises Regulatory Affairs Associates and Senior Associates, including assigning and prioritizing workload, monitoring performance, and ensuring equitable distribution of study portfolios.
- Provides day-to-day leadership, coaching, and mentorship to staff operating with varying levels of autonomy.
- Supports hiring, onboarding, and professional development while maintaining appropriate span of control for a high-complexity regulatory environment.
Regulatory Compliance and Risk Management (15%)
- Maintains institutional compliance with applicable federal regulations (FDA, ICH-GCP), sponsor requirements, and BCM/TCH policies.
- Proactively identifies compliance risks, escalates issues as appropriate, and implements corrective actions.
- Ensures audit readiness and supports internal and external audits/inspections.
Protocol Support and Regulatory Coordination (10%)
- Provides regulatory support for clinical protocols by coordinating submissions, reviewing regulatory content for completeness and compliance, and ensuring alignment with institutional requirements.
- Collaborates with protocol development and cross-functional teams to support study activation and amendment processes.
Regulatory Strategy, Interpretation, and Stakeholder Guidance (10%)
- Serves as a regulatory subject matter expert, interpreting evolving regulations and providing strategic guidance to investigators, study teams, and leadership.
- Interfaces with institutional partners and sponsors as needed to facilitate study approvals and ongoing compliance.
SOP Development, Training, and Continuous Improvement (10%)
- Develops, updates, and enforces standard operating procedures (SOPs) to standardize regulatory processes.
- Trains regulatory and cross-functional staff on SOPs, regulatory requirements, and best practices.
- Identifies process gaps and drives continuous improvement initiatives.
Systems, Reporting, and Documentation Management (10%)
- Oversees maintenance of regulatory systems, databases, and document repositories.
- Ensures accurate and timely updates to electronic regulatory records and supports reporting and tracking of key regulatory metrics and submission timelines.
- Performs other job-related duties as assigned.
- Bachelor's degree.
- Four years of relevant experience.
- At least four years of regulatory or clinical research experience
- Demonstrated experience managing regulatory submissions, multi-study/site portfolios, and staff supervision
- Master's degree
- Certification as a Clinical Research Professional (CRP) or Clinical Research Coordinator (CRC) (SoCRA or ACRP)
Work Authorization Requirement:
This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.