Research Regulatory Coordinator

Position Purpose The Research Regulatory Coordinator provides operational regulatory and IRB support for clinical research studies conducted at the site, including investigatorinitiated, industrysponsored, cooperative group, and federally funded studies. This role is responsible for daytoday regulatory operations, including IRB submissions and maintenance, regulatory document management, audit readiness activities, SOP implementation, research system maintenance, and coordination with investigators, study teams, sponsors, and IRBs. This position supports research execution, not institutional compliance enforcement, and focuses on enabling highquality, efficient, and auditready clinical research operations study portfolios. Nature and Scope The Research Regulatory Coordinator works closely with investigators, clinical research coordinators, research leadership, and external stakeholders (e.g., sponsors, CROs, cooperative groups, and IRBs) to ensure regulatory requirements are operationalized consistently across studies. The role supports both local and central IRB workflows, maintains regulatory systems and files, and contributes to internal quality activities that support inspection readiness. This position does not provide patient care Disclaimer The foregoing description is not intended to be, and should not be construed as, an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be an accurate reflection of the general nature and level of the job. Minimum Qualifications Requirements - Required and/or

Preferred Name Description Education:

Ability to read, write, speak, and understand English sufficiently to perform job duties safely and effectively. A Bachelor's degree is required as well as expert working knowledge of regulatory requirements for research trials involving human subjects. 4 years of experience in clinical research regulatory support, IRB coordination, and/or clinical research operations may substitute for degree requirement.

Experience:

Demonstrated experience with IRB submissions and regulatory document management across multiple studies. Working knowledge of human subject's research regulations as applied to operational study conduct. Experience working with both industries, investigator initiated, and federally sponsored studies preferred. License(s): None Certification(s): Clinical research certification (e.g., CCRC, CCRP, ACRP) preferred. Computer /

Typing:

Must be proficient with Microsoft Office Suite, including Outlook, PowerPoint, Excel, Teams, and Word and have the ability to use the computer to complete online learning requirements for job-specific competencies, access online forms and policies, complete online benefits enrollment, etc.

Location:

Renown Health • 250701

Administration Schedule:

Full Time - Eligible for Benefits, Day, 8:00 am-5:00 pm