Clinical Regulatory Manager

Saint Louis University•St. Louis, MO

19h

About The Position

The Clinical Research Regulatory Manager oversees clinical research regulatory activities across all units supporting industry-sponsored, National Institutes of Health (NIH), and other grant-funded studies at Saint Louis University. The position promotes compliance with applicable federal and state regulations, institutional policies and procedures, and requirements governing human subjects research. The manager coordinates regulatory submissions and Institutional Review Board (IRB) review processes, monitors submission status and documentation requirements, and supports compliance with approved research protocols and applicable regulatory standards. The role also contributes to clinical trial oversight, coverage analysis development, clinical trial contract and budget coordination, regulatory policy and procedure development, and staff training. Working collaboratively with principal investigators, physicians, clinical research coordinators, university offices, sponsors, and external research partners, the Clinical Research Regulatory Manager facilitates efficient regulatory workflows, supports timely study activation and ongoing compliance, and promotes consistent regulatory practices across clinical research activities. The position requires a strong working knowledge of Food and Drug Administration (FDA) regulations and applicable human research protection and Good Clinical Practice (GCP) guidelines.

Requirements

Associate degree.
Five years of related experience, primarily in clinical research, including at least two years of regulatory compliance experience.
Prior experience preparing and submitting applications to an Institutional Review Board (IRB).
Strong working knowledge of applicable FDA regulations, Office for Human Research Protections (OHRP) requirements, International Council for Harmonization (ICH) guidelines, and Good Clinical Practice (GCP) standards relevant to clinical research.
Knowledge of clinical research regulatory requirements, human subjects protection, IRB submission processes, and institutional research policies and procedures.
Working knowledge of Medicare coverage and medical billing processes relevant to clinical trials.
Strong written and verbal communication skills, including the ability to explain regulatory requirements, communicate outstanding action items, and tailor information to audiences with varying levels of regulatory expertise.
Ability to build effective working relationships and collaborate with physicians, principal investigators, study coordinators, university departments, sponsors, and external research partners.
Strong analytical, organizational, planning, and time-management skills, with exceptional attention to detail and accuracy.
Ability to manage multiple studies, projects, deadlines, and competing priorities while maintaining accurate records and ensuring timely follow-up.
Ability to identify missing information, track outstanding requirements, resolve workflow issues, and support consistent regulatory practices.
Ability to learn new regulatory processes, systems, and institutional procedures efficiently.
High degree of integrity, professionalism, accountability, and ethical judgment when handling research documentation and confidential information.
Proficiency in Microsoft Office applications, particularly Word and Excel, and ability to use Adobe Acrobat and DocuSign for research documentation and related workflows.

Nice To Haves

Bachelor's degree.
Additional experience in clinical research, regulatory affairs, or clinical research compliance.
Current certification through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA), or active progress toward certification.
Completion of Good Clinical Practice (GCP) training.

Responsibilities

Coordinate preparation, completion, and submission of initial and continuing review applications and other required regulatory documentation to the Institutional Review Board (IRB). Monitor submission status, identify outstanding requirements, follow up with investigators and study coordinators, and communicate action items to facilitate timely review and ongoing compliance.
Support compliance with applicable federal and state regulations, FDA requirements, human subjects protection standards, institutional policies, and approved study protocols. Identify outstanding regulatory requirements and work with research teams to facilitate timely resolution.
Assist in developing and reviewing clinical trial coverage analyses in accordance with applicable federal Medicare coverage and billing guidelines, collaborating with stakeholders to support appropriate research-related billing practices.
Facilitate review and processing of clinical trial contracts and budgets in collaboration with principal investigators, sponsors, and appropriate internal and external university offices.
Serve as the university administrator responsible for compliance oversight of the applicable national clinical trials registry, supporting accurate, complete, and timely registration and reporting.
Contribute to developing, reviewing, implementing, and evaluating regulatory policies, procedures, and workflows. Promote consistent documentation practices and continuous improvement of regulatory processes across clinical research units.
Provide onboarding, guidance, and training support to clinical research regulatory coordinators, including newly assigned coordinators. Reinforce regulatory workflows, documentation standards, institutional procedures, and effective use of research systems.
Participate in clinical trial monitoring activities as appropriate and collaborate with investigators, physicians, study coordinators, and research partners to address regulatory documentation needs and support adherence to approved protocols and applicable requirements.
Communicate with internal and external stakeholders regarding regulatory submissions, outstanding documentation, deadlines, and required follow-up actions, and foster collaborative working relationships.
Participate in relevant training, educational programs, and in-service sessions to maintain current regulatory knowledge. Perform other duties as assigned.