Manager, Regulatory Affairs
Apply NowCompany: Baylor College of Medicine
Location: Houston, TX 77084
Description:
Job Title: Manager, Regulatory Affairs
Division: Pediatrics
Work Arrangement: Hybrid
Location: Hybrid within Greater Houston, TX
Salary Range: $111,000 - $130,000
FLSA Status: Exempt
Work Schedule: Monday - Friday, 8 a.m. - 5 p.m.
Summary
Manages and oversees research activities for a research study or clinical trial. Develops and maintains complex clinical research protocols and corresponds/submits documents to regulatory agencies on behalf of investigators. Maintains current knowledge of regulations and provides guidance to investigators and staff.
The position is eligible for a hybrid work schedule.
Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) are eligible for certification pay.
Job Duties
Minimum Qualifications
Preferred Qualifications
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Requisition ID: 22117
Division: Pediatrics
Work Arrangement: Hybrid
Location: Hybrid within Greater Houston, TX
Salary Range: $111,000 - $130,000
FLSA Status: Exempt
Work Schedule: Monday - Friday, 8 a.m. - 5 p.m.
Summary
Manages and oversees research activities for a research study or clinical trial. Develops and maintains complex clinical research protocols and corresponds/submits documents to regulatory agencies on behalf of investigators. Maintains current knowledge of regulations and provides guidance to investigators and staff.
The position is eligible for a hybrid work schedule.
Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) are eligible for certification pay.
Job Duties
- Manages research activities for a research study or clinical trial.
- Processes and maintains INDs/IDEs for investigator initiated studies.
- Develops clinical trial protocols for investigator initiated protocols.
- Interacts with government agencies such as FDA as need for specific projects and regulatory requirements as needed.
- Maintains current knowledge of regulations and provides guidance to investigators and staff.
- Trains other regulatory team members on their applicable SOPs.
- Maintains regulatory and institutional compliance for RRO projects.
- Develops and maintains SOPs.
- Updates electronic databases and external records for studies as needed.
- Supervises other regulatory team members as assigned.
- Responsible for directing and providing work assignments to Regulatory Affairs staff.
- Performs other job-related duties as assigned.
Minimum Qualifications
- Bachelor's degree.
- Four years of relevant experience.
Preferred Qualifications
- Master's degree a plus.
- Certification as either a Clinical Research Professional (CRP), or Clinical Research Coordinator (CRC) from the Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) is strongly preferred for this role.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Requisition ID: 22117