Research Regulatory Coordinator

ThedaCare • Neenah, WI

1d • Onsite

About The Position

The Research Regulatory Coordinator manages compliance, documentation, and submissions for clinical trials and human subject’s research. This role acts as the primary liaison between clinical investigators, institutional review boards (IRBs), and study sponsors. The ideal candidate will ensure all research activities strictly adhere to federal, state, and institutional guidelines.

Requirements

• Bachelor’s degree in healthcare administration, life sciences, public health, or a related field.
• Minimum of 2 years of direct experience in clinical research, research regulatory affairs or IRB administration.
• Strong understanding of FDA regulations, HHS human subject protections (45 CFR 46), and ICH/GCP guidelines.

Nice To Haves

• One or more of the following preferred and/or able to obtain within 6 months of hire: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or Certified Institutional Review Board Professional (CIP).
• Proficiency with data management platforms for the submission of Case Report Forms, electronic IRB submission portals, and safety reporting.
• Direct experience preparing for and participating in successful FDA audits, sponsor inspections, post-approval monitoring or quality assurance audits and site visits.

Responsibilities

• Prepare, submit, and track initial protocols, amendments, continuing reviews, and safety reports to the IRB.
• Maintains organized records of all regulatory submission, approvals, and correspondence with regulatory bodies; maintains master regulatory binders (paper and electronic) ensuring audit-ready status at all times.
• Coordinate the collection, maintenance and storage of essential documents, including investigator CVs, medical licenses, financial disclosure forms, and organization required trainings.
• Maintain knowledge of current federal, state, and organizational regulations, guidelines, and industry standards related to research and ensures research activities comply with federal, state, and organizational regulations related to human subject research.
• Assist in the review of research protocols to ensure compliance with regulatory standards. Monitors study timelines as outlined with the sponsor and protocol.
• Acts as a resource for researchers, research office staff, learners and residents regarding regulatory process and documentation standards.
• Serves as the central point of contact for researchers, sponsors, contract research organizations (CROs), IRB, regulatory bodies and stakeholders.
• Assist with internal quality assurance audits, post approval monitoring and external inspections by federal agencies or sponsors.

Benefits

• Lifestyle Engagement e.g. health coaches, relaxation rooms, health focused apps (Wonder, Ripple), mental health support
• Access & Affordability e.g. minimal or zero copays, team member cost sharing premiums, daycare
• continued opportunities for learning and development
• accessible and transparent leadership
• a commitment to work/life balance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level