Top 1 Licensing specialist Jobs in Lapeer, Mi

Research Compliance Quality Improvement Education Specialist - HYBRID - Part Time
McLaren Health Care —Grand Blanc, MI
- Extended hours
- Nursing
- Surgery
- 5 years

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Research Compliance Quality Improvement Education Specialist - HYBRID - Part Time

McLaren Health Care -
Grand Blanc, MI

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Job Details

Part-time

Qualifications

Nursing
Process audits
Research ethical considerations
Clinical research audit management
5 years
Program development
HIPAA
Healthcare documentation compliance audits
Implementing healthcare compliance training programs
Clinical staff training
Bachelor's degree
Research safety & compliance
Staff training
Quality improvement
Quality inspection
Regulatory readiness in healthcare
Clinical trial standard operating procedures
Research administration
Educational program planning
Clinical quality assurance standards
Senior level
Standard operating procedures (SOPs)
Professional development training

Full 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.

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

Additional Information

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

About Us

McLaren Health Care, headquartered in Grand Blanc, Michigan, is a $7.3 billion, fully integrated health care delivery system committed to quality, evidence-based patient care and cost efficiency. The McLaren system includes 12 hospitals in Michigan, ambulatory surgery centers, imaging centers, a 640-member employed primary and specialty care physician network, commercial and Medicaid HMOs covering more than 732,838 lives in Michigan and Indiana, home health, infusion and hospice providers, pharmacy services, a clinical laboratory network and a wholly owned medical malpractice insurance company. McLaren operates Michigan’s largest network of cancer centers and providers, anchored by the Karmanos Cancer Institute, a National Cancer Institute-designated comprehensive cancer centers. McLaren has 20,000 full-, part-time and contracted employees and more than 113,000 network providers throughout Michigan, Indiana and Ohio.

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Research Compliance Quality Improvement Education Specialist - HYBRID - Part Time

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