Research Regulatory Coordinator
About this role
Why ThedaCare?
Living A Life Inspired!
Our new vision at ThedaCare is bold, ambitious, and ignited by a shared passion to provide outstanding care. We are inspired to reinvent health care by becoming a proactive partner in health, enriching the lives of all and creating value in everything we do. Each of us are called to take action in delivering higher standards of care, lower costs and a healthier future for our patients, our families, our communities and our world.
At ThedaCare, our team members are empowered to be the catalyst of change through our values of compassion, excellence, leadership, innovation, and agility. A career means much more than excellent compensation and benefits. Our team members are supported by continued opportunities for learning and development, accessible and transparent leadership, and a commitment to work/life balance. If you’re interested in joining a health care system that is changing the face of care and well-being in our community, we encourage you to explore a future with ThedaCare.
Benefits, with a whole-person approach to wellness –
- 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
Summary :
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.Job Description:
Essential Duties and Responsibilities
- IRB Submissions: Prepare, submit, and track initial protocols, amendments, continuing reviews, and safety reports to the IRB.
- Regulatory Documentation: 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.
- Study Startup: Coordinate the collection, maintenance and storage of essential documents, including investigator CVs, medical licenses, financial disclosure forms, and organization required trainings.
- Compliance Monitoring: 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.
- Protocol Review & Study Tracking: Assist in the review of research protocols to ensure compliance with regulatory standards. Monitors study timelines as outlined with the sponsor and protocol.
- Trains & Supports: Acts as a resource for researchers, research office staff, learners and residents regarding regulatory process and documentation standards.
- Communicates & Works Collaboratively: Serves as the central point of contact for researchers, sponsors, contract research organizations (CROs), IRB, regulatory bodies and stakeholders.
- Audit & Monitor Visit Preparation: Assist with internal quality assurance audits, post approval monitoring and external inspections by federal agencies or sponsors.
Required Qualifications
- Education: Bachelor’s degree in healthcare administration, life sciences, public health, or a related field.
- Experience: Minimum of 2 years of direct experience in clinical research, research regulatory affairs or IRB administration.
- Knowledge: Strong understanding of FDA regulations, HHS human subject protections (45 CFR 46), and ICH/GCP guidelines.
Preferred Qualifications
- 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).
- Technology: Proficiency with data management platforms for the submission of Case Report Forms, electronic IRB submission portals, and safety reporting.
- Audit Readiness and Post Approval Monitoring: Direct experience preparing for and participating in successful FDA audits, sponsor inspections, post-approval monitoring or quality assurance audits and site visits.