Senior Clinical Research Regulatory Manager

Saint Louis University; St. Louis (MO); On-site; USD 80,000 - 110,000; Full time

Job summary

Saint Louis University seeks a Clinical Research Regulatory Manager to oversee regulatory activities for industry-sponsored and NIH-funded studies. You will coordinate IRB submissions, ensure FDA/GCP compliance, and support budgeting, contracts, and registry oversight across multiple units.

The role requires strong knowledge of FDA regulations, human subjects protections, and Good Clinical Practice, with experience in regulatory workflows, training, and collaboration with investigators and

Qualifications

• Associate degree; five years of clinical research experience with regulatory compliance.
• IRB submission experience and familiarity with FDA/ICH/GCP standards.
• Knowledge of Medicare coverage and billing practices for trials.
• Preferred: Bachelor's degree and professional certification (ACRP or SOCRA) or active progress toward certification.
• Strong written and verbal communication skills and ability to coordinate with diverse stakeholders.

Responsibilities

• Coordinate initial and continuing regulatory submissions to the IRB and tracking of status.
• Support compliance with FDA, OHRP, and GCP requirements across studies.
• Assist with clinical trial coverage analyses and budget/contract coordination.
• Oversee registry registration and reporting for applicable clinical trials.
• Develop and implement regulatory policies, procedures, and training.
• Provide onboarding and ongoing training to regulatory coordinators.

Skills

FDA regulations

IRB submissions

GCP guidelines

Regulatory compliance

Medicare billing

Documentation

Communication

Regulatory affairs

Education

Associate degree

Bachelor's degree

Tools

DocuSign

Adobe Acrobat

Excel

Word

Job description

Saint Louis University seeks a Clinical Research Regulatory Manager to oversee regulatory activities for industry-sponsored and NIH-funded studies. You will coordinate IRB submissions, ensure FDA/GCP compliance, and support budgeting, contracts, and registry oversight across multiple units.

The role requires strong knowledge of FDA regulations, human subjects protections, and Good Clinical Practice, with experience in regulatory workflows, training, and collaboration with investigators and