Research Compliance Quality Improvement Education Specialist - HYBRID

McLaren Health Care; Lansing (MI); On-site; USD 70,000 - 90,000; Part time

Job summary

A leading healthcare organization in Michigan seeks a part-time Compliance Educator to provide ongoing support and education for the research community. You will facilitate training programs and ensure compliance with federal and institutional regulations. The ideal candidate has a Bachelor’s degree in a scientific discipline and at least 5 years of relevant experience. This role offers flexibility in work schedules, especially during audits, and focuses on promoting responsible research conduct.

Qualifications

• 5 years of direct experience with HRPP, IRB, and/or research compliance.
• Ability to develop and present educational sessions.
• Experience in conducting compliance reviews and audits.

Responsibilities

• Facilitate system-wide training and workshops for research staff.
• Develop comprehensive clinical research compliance audits.
• Conduct quality improvement reviews to ensure compliance with protocols.
• Develop and implement a comprehensive clinical research compliance auditing plan.
• Plan and conduct compliance reviews of research activities against SOPs and regulations.
• Perform quality improvement reviews to ensure data handling per protocol and GCP.

Skills

Regulatory compliance

Education and training

Auditing

Quality improvement

Human Research Protection Program (HRPP)

Education

Bachelor’s degree in a scientific discipline or related field

Certification in Healthcare Research Compliance (CHRC)

Job description

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.

Required Qualifications

• 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 Qualifications

• Degree in nursing.
• Experience with AAHRPP Accreditation process.

Equal Opportunity Employer of Minorities/Females/Disabled/Veterans

The firm is an equal opportunity employer and welcomes applications from individuals of all backgrounds.

Additional Information

• Schedule: Part‑time
• Requisition ID: 26001619
• Daily Work Times: Standard Business Hours
• Hours Per Pay Period: 40
• On Call: No
• Weekends: No