Community Health Network is seeking a Research Compliance Coordinator to support the development and management of a sustainable research compliance program. Working under the oversight of the Research Compliance Manager, you will assist with planning, coordination, and continuous improvement to ensure adherence to internal and external rules and regulations.
What You'll Do
- Act as a key contributor to the development and monitoring of the safety and quality program.
- Develop and maintain quality and risk assessment tools and checklists.
- Work with leadership to provide feedback on audit deficiencies and trends to drive effective change.
- Plan, conduct, and manage audits of all research activity to evaluate compliance with federal regulations, international guidelines, SOPs, and other requirements.
- Conduct audit debriefs with project teams and leadership as required.
- Follow up to obtain audit responses and review them for appropriateness and completeness.
- Track and conduct periodic follow-up on all Corrective Action Preventative Action (CAPA) plans.
- Collaborate with research teams and principal investigators on responses to audit findings and CAPA plans.
- Assist research teams in planning and preparing for external audits.
- Partner with research compliance staff to foster a culture of compliance and implement action plans.
- Provide education to study teams regarding compliance and areas of deficiency.
- Ensure compliance with all training requirements.
- Evaluate and recommend compliance with standards for research ethics, integrity, safety, data security, privacy, and human subjects protection.
- Organize reports to internal stakeholders, including the Network Compliance department, about the research program.
What We're Looking For
- An Associate Degree or 2-year degree.
Nice to Have
- 3+ years of experience in clinical research compliance or auditing.
- A Bachelor's Degree or 4-year degree.
- Certified Clinical Research Associate (CCRA-ACRP) certification.
Team & Environment
You will work under the oversight of the Research Compliance Manager.
