Senior Clinical Research Regulatory Lead

slu; St. Louis (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Saint Louis University seeks a Clinical Research Regulatory Manager to oversee regulatory activities for industry-sponsored, NIH, and grant-funded studies. The role coordinates IRB submissions, maintains compliance with FDA regulations, and supports clinical trial oversight and budgeting.

The position collaborates with investigators, coordinators, and sponsors to ensure timely study activation and ongoing regulatory adherence, including policy development and staff training.

Qualifications

• Experience coordinating regulatory submissions and IRB reviews.
• Strong knowledge of FDA regulations and GCP guidelines.

Responsibilities

• Regulatory Submissions and IRB Coordination: Prepare and submit initial and continuing reviews to the IRB; monitor status and ensure timely actions.
• Regulatory Compliance and Oversight: Ensure compliance with federal/state regulations, FDA requirements, and study protocols.
• Clinical Trial Coverage Analysis: Assist in developing Medicare coverage analyses for billing practices.
• Clinical Trial Contracts and Budgets: Facilitate review and processing in collaboration with investigators and sponsors.
• Clinical Trial Registry Oversight: Administer compliance with national trial registries and reporting requirements.
• Policy and Procedure Development: Contribute to regulatory policy development and workflow improvements.
• Training and Staff Development: Provide onboarding and ongoing training to regulatory coordinators.
• Clinical Trial Monitoring and Coordination: Participate in monitoring activities and address documentation needs.
• Communication and Collaboration: Maintain stakeholder communications regarding submissions and deadlines.
• Professional Development and Other Duties: Engage in training and ongoing education to maintain regulatory knowledge.

Skills

FDA regulations knowledge

OHRP requirements

ICH guidelines

GCP familiarity

Regulatory submissions

Job description

Saint Louis University seeks a Clinical Research Regulatory Manager to oversee regulatory activities for industry-sponsored, NIH, and grant-funded studies. The role coordinates IRB submissions, maintains compliance with FDA regulations, and supports clinical trial oversight and budgeting.

The position collaborates with investigators, coordinators, and sponsors to ensure timely study activation and ongoing regulatory adherence, including policy development and staff training.