Manager-Human Research Protection Program - York Hospital

York, PA | Professional | Tracking Code: 54605

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General Summary:

Under the supervision of the Corporate Director-Emig Research Center, manages the System’s comprehensive Human Research Protection Program (HRPP), including the WellSpan Health Institutional Review Board (WSH IRB). Promotes the protection of human research participants through the management of a system-wide program that fosters a culture of respect for human research participants, including timely and thorough review of research protocols, meaningful education of the research community and proactive monitoring of the conduct of human subjects research. Manages the administration of the HRPP in compliance with relevant federal regulations, state laws, sponsor requirements and System policies and procedures. Responsible for continued accreditation by and compliance with the standards of the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Provides consultation and technical support to the Institutional Review Board (IRB), investigators, and research support staff. Manages the Quality Assessment program for research activities.

Duties and Responsibilities:

  1. Manages the System’s comprehensive Human Research Protection Program (HRPP), including the WellSpan Health Institutional Review Board (WSH IRB) and research compliance activities. 
  2. Promotes the protection of human research participants through the management of a system-wide program that fosters a culture of respect for human research participants, including timely and thorough review of research protocols, meaningful education of the research community and proactive monitoring of the conduct of human subjects research.
  3. Addresses inquiries and responses regarding allegations of noncompliance by investigators and/or the IRB and reports of adverse events. Assists in identifying corrective actions to ensure the protections of human subjects compliance with institutional policy.
  4. Serves as the lead contact for inquiries regarding inquiries from Department of Health and Human Services, Food and Drug Administration, National Institute of Health, National Cancer Institute and the Association for the Accreditation of Human Research Protection Programs, Inc. Ensures thorough and timely responses in collaboration with the Corporate Director – Emig Research Center, Federal Wide Signatory Authority, and when necessary, Corporate Compliance and Risk Management.
  5. Provides oversight and management of personnel and daily operations of the HRPP including the hiring and performance management of HRPP staff.
  6. Develops, maintains and enforces standard operating procedures (SOPs)for all HRPP business, processing and record keeping consistent with the WellSpan Manual of Administrative Policy (MAP), multiple Institutional policies and government regulations regarding research regulations.
  7. Conducts regulatory review of investigator-initiated research and participates on the WSH IRB as assigned by the IRB Executive Committee. Serves as HIPAA Privacy Rule Reviewer for research as assigned.
  8. Maintains AAHRPP, Inc. accreditation by meeting established standards, submitting required status reports and participating in re-accreditation process.
  9. Provide oversight for the HRPP Quality Assurance program for research and patriciates as an auditor as required
  10. Provides regulatory consultation and technical support to investigators and research support staff.
  11. Provides oversight and manages IRBNet, a web-based electronic IRB submission and review program and CITI Program, a web-based human research protection training program.
  12. Ensures the periodic performance review of the IRB membership and composition to maintain a diverse, qualified, membership. Assists in recruiting prospective IRB members and make recommendations to the IRB Executive Committee.
  13. Development and administration of educational material in regard to research record keeping, research compliance, and WellSpan Health Policy and Procedures for Research, Federal Regulations for Research and Good Clinical Practices.
  14. Securely maintains all IRB records with restricted access as appropriate including agendas, minutes, policies, regulations,          reference materials and individual protocol files. Ensures only authorized personnel have access to confidential data/records/information. Reports any security breach immediately.
  15. Prepares reports of protocol status and other reports as requested by the IRB Executive Committee, System Administration or regulatory agencies. 
  16. Keeps abreast of changing requirements of certification by organizations that assure the quality of WellSpan’s HRRP.

 

 

Required Skills

Minimum Education:        Bachelor’s Degree

Preferred Education:        Master's Degree

Required Certification:     

Clinical Research Regulations, Regulatory Compliance, Medical Terminology

Certified IRB Professional (CIP) certification through PRIM&R within three years of hire

Required Experience

2 - 3 years in clinical research

Understanding of HIPAA Privacy Rule.

Clinical Research Regulations, Regulatory Compliance, Medical Terminology


Quality of Life

WellSpan Health is an integrated health system that serves the communities of central Pennsylvania and northern Maryland. The organization is comprised of a multispecialty medical group of more than 1,200 physicians and advanced practice clinicians, a regional behavioral health organization, a home care organization, six respected hospitals, more than 15,000 employees, and 140 patient care locations. WellSpan is a charitable, mission-driven organization, committed to exceptional care for all, lifelong wellness and healthy communities. We are committed to transforming the health of the communities we serve and to educating the next generation of clinicians, staff and leaders.

Quality of Life
Quality of Life

Founded in 1741, the city of York is considered by many as the first capital of the United States. The Articles of Confederation were signed by the Second Continental Congress here in 1777. Its beautifully restored historic district is an architectural treasure. While York retains its farming and manufacturing heritage, at its heart York is a thriving cultural community that has attracted creative talent and innovative entrepreneurial investors from across the nation.

Life in York County offers affordable housing, options for higher education, a thriving arts and cultural community, historical attractions, parks and recreational resources, semi-professional baseball team, fine dining and more — within an easy drive of major East Coast cities.

York County residents can find local employment in healthcare, manufacturing, technology, agricultural and service sectors. (Patient population: 445,000)

Equal Opportunity Employment

WellSpan Health is an equal opportunity employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color or any other protected class. WellSpan Health does, however, have a tobacco-free/nicotine-free hiring policy.

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