Responsible for providing on-going support and education to the research community at McLaren and its subsidiary hospitals to ensure compliance with applicable institutional, FDA, OHRP, HIPAA, and GCP requirements and guidelines. In addition, this position provides administrative support in cases of alleged Research Misconduct and other research compliance matters. Position often requires extended hours and flexibility in work schedules immediately prior to and during audits, inspection, accreditation visits, and for special projects.
Essential Functions and Responsibilities:
Facilitate the execution of system wide training programs, workshops and conferences for investigators, IRB members and research staff:
Develops and presents monthly education sessions.
Coordinates and presents workshops on issues in the area of regulatory compliance and/or best practices.
Conducts annual conferences on human research protections.
Supports the research community through the development of a responsible conduct of research education program and by providing tools to aid in the appropriate conduct of research.
Responsible for developing and implementing a comprehensive clinical research compliance auditing plan.
Plans and conducts compliance review activities associated with clinical research studies that include but are not limited to the review of all research-related activities and documents to assess and evaluate the compliance of those activities to internal policies, standards operating procedures (SOP's), and relevant regulatory requirements.
Plans and conducts quality improvement reviews to verify that clinical data are generated, collected, handled, analyzed, and reported according to protocol, SOP's, Good Clinical Practices, and relevant regulatory requirement.
Qualifications:
Required:
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
Preferred:
Degree in nursing
Experience with AAHRPP Accreditation process.
Equal Opportunity Employer of Minorities/Females/Disabled/Veterans