Research Compliance Quality Improvement Education Specialist - HYBRID - Part Time

Responsiblefor providing on-going support and education to the research community at McLarenand its subsidiary hospitals to ensure compliance with applicableinstitutional, FDA, OHRP, HIPAA, and GCP requirements and guidelines. In addition, this position provides administrative support in cases ofalleged Research Misconduct and other research compliance matters. Position often requires extended hours andflexibility in work schedules immediately prior to and during audits,inspection, accreditation visits, and for special projects.

• Facilitatethe execution of system wide training programs, workshops and conferences for investigators,IRB members and research staff:
• Develops and presentsmonthly education sessions.
• Coordinates and presentsworkshops on issues in the area of regulatory compliance and/or best practices.
• Conducts annualconferences on human research protections.
• Supports theresearch community through the development of a responsible conduct of researcheducation program and by providing tools to aid in the appropriate conduct ofresearch.
• Responsible for developing and implementing a comprehensiveclinical research compliance auditing plan.
• Plans and conducts compliance review activities associated with clinicalresearch studies that include but are not limited to the review of allresearch-related activities and documents to assess and evaluate the complianceof those activities to internal policies, standards operating procedures(SOP's), and relevant regulatory requirements.
• Plans and conductsquality improvement reviews to verify that clinical data are generated,collected, handled, analyzed, and reported according to protocol, SOP's, GoodClinical Practices, and relevant regulatory requirement.

• Bachelor's degree in a scientific discipline or a related field or equivalent combination of education and experience.
• 5 years of direct experience with HRPP, IRB, and/or research compliance.
• Certification in Healthcare Research Compliance (CHRC) or able to obtain within 2 years of hire

• Degree in nursing
• Experience with AAHRPP Accreditation process.