R
esponsible
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 Functionsand Responsibilities:
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 andconducts 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.
Qualifications:
Required:
Bachelor's degree in a scientific discipline or arelated field or equivalent combination of education and experience.
5 years of direct experience with HRPP, IRB, and/orresearch compliance.
Certification in Healthcare Research Compliance(CHRC) or able to obtain within 2 years of hire
Preferred:
Equal Opportunity Employer of Minorities/Females/Disabled/Veterans
