Human Research Protections Program (HRPP) Specialist

Overview

Western Michigan University Homer Stryker, MD, School of Medicine is hiring for a Human Research Protections Program (HRPP) Specialist. The Western Michigan University Homer Stryker M.D. School of Medicine (WMed) Human Research Protection Program (HRPP) and Institutional Review Board (IRB) operates under the authority of the medical school. The HRPP/IRB oversees the ethical conduct of research for the entire WMed research community and affiliated hospital systems and clinics including all student-led research, collaborative international research, and Food & Drug Administration (FDA)-regulated clinical research.  The HRPP Specialist serves as an expert consultant to the WMed Institutional Review Board (IRB), the Chair and its members. The HRPP Specialist facilitates the review and approval process of research proposals using independent judgment in interpreting and applying relevant federal and state laws, regulations, policies and guidelines; evaluates protocol submissions to determine if proposed research is ethically acceptable and compliant with relevant regulations; instructs the IRB Chair, members and researchers on the regulations and ethical principles essential to the review process, and provides training and advice as needed.

- Flexible work solutions available. 

Candidates must have a cover letter as part of the submission process. 

Responsibilities

• Coordination, evaluation, and processing of submissions to the WMed IRB.
  • Conducts non-human research, exempt, and non-engagement determinations.
  • Conducts pre-review of submissions (initial, continuing review, modifications, unanticipated problems, deviations, etc.) to ensure compliance with Federal regulations and WMed’s policies and procedures and those submissions are complete and accurate prior to assigning for review.
• Coordination with external IRBs.
  • Conducts pre-review of requests to submit to an external IRB to ensure all requirements have been fulfilled and that necessary approvals and agreements are in place prior to submission to the external IRB.
  • Coordinates with other committees and offices to ensure that internal requirements are fulfilled and that information is shared with appropriate parties (e.g., COI, IBC, Sponsored Programs, affiliates, and local context review for when External IRB’s are used).
  • Evaluate ongoing reports and correspondence related to research under the oversight of external IRBs to identify and items that might require internal action or follow up.
• Partner and maintain necessary documentation to support regulatory guidance for HRPP and IRB.
• May serve as a voting member of the convened IRB and a designated Expedited Reviewer to review and approve non-exempt minimal risk research using expedited review procedures as well as not human subjects, research, and exempt determinations.
• Utilize subject matter expertise to serve as a resource to IRB members, researchers and others on IRB topics.
• Partner with other members of the HRPP and IRB in the development and refinement of SOPs, guidance documents, forms and checklists.
• Assists with the compliance monitoring and audit program by organizing and performing random, for-cause, and IRB requested audits of clinical research projects, reviews research and medical records and processes to assess compliance with protocols and all Federal, State and WMed requirements and guidelines. Analyzes data and prepares and presents audit reports and summaries; provides feedback to researchers and the IRB as appropriate.
• Availability to work on weekends or evenings to complete time sensitive projects.
• Acquires knowledge for new technology and policy/procedure revisions.
• Assists with identifying educational needs of researchers based on audits and other information. Designs, develops, presents, and evaluates targeted training programs and materials based on audit results and regulatory updates.
• Supports the maintenance of the electronic submission software system and assigns and tracks protocols through the review process, prepares and sends notification and documents related to the review and approval process, and communicates with the IRB.
• Assists with specific inquiries related to scientific misconduct and/or IRB related non-compliance issues, as requested.
• All other duties as assigned.

Qualifications

EDUCATION AND/OR EXPERIENCE: 

• Bachelors of Arts or Bachelors of Science; Masters or advanced degree preferred.
• A minimum of 5 years’ experience in IRB administration is preferred. Experience in IRB administration in a clinical environment is strongly preferred.
• Experience with making non-human research, exempt, and non-engagement determinations strongly preferred
• Good working knowledge of Federal regulations, guidance, and practice standards for human research (21 CFR 50, 56, 213, 812; and 45 CFR 46) and other regulations (e.g., HIPAA) that impact the conduct and IRB review of research, with the ability to apply this knowledge across a diverse portfolio of research.
• Demonstrated ability to utilize common software such as Word, Excel, PowerPoint, SharePoint; ability to learn new software as required and remain proficient in all programs necessary to perform duties of this position.
• Experience with electronic IRB submission system preferred.

LICENSES, REGISTRATIONS, CERTIFICATIONS: 

• Certified IRB Professional (CIP) required within 1 year of eligibility

OTHER SKILLS AND ABILITIES: 

• Establishes and maintains a culture of excellence, inclusion, and superior customer service by providing guidance on best practices.
• Requires strong analytic skills and the ability to manage multiple, complex activities while maintaining close attention to detail.
• Applicants must have strong organizational abilities and demonstrated success in meeting multiple deadlines.
• Applicants must demonstrate sound professional judgment, excellent problem-solving, organizational, interpersonal, and time management skills
• Ability to communicate effectively both verbally and in writing with investigators, research teams and colleagues.
• Demonstrates the ability to recognize priorities in organization of work flow.
• Able to perform duties independently, with a minimal need for direct supervision.

About Western Michigan University Homer Stryker M.D. School of Medicine (WMed)

We are committed to excellence and health equity through transformative medical education, high-quality, patient- and family-entered care, innovative research, and community partnerships within a just culture of diversity, equity, inclusion, and belonging. Our vision is health equity for all in Southwest Michigan through innovation in the practice and study of medicine.

The medical school is a collaboration of Western Michigan University and Kalamazoo's two teaching health systems, Ascension Borgess and Bronson Healthcare. The medical school is a private nonprofit corporation supported by private gifts, clinical revenues, research activities, tuition, and endowment income. WMed is the recipient of a $100 million foundational gift and the Empowering Futures Gift, a philanthropic commitment of $300 million to support the mission of the medical school. WMed contributes to the economic vitality of Southwest Michigan through the services we provide as well as the creation of 1,600 new jobs and an annual estimated economic impact of $353 million in Kalamazoo and Calhoun counties.

WMed is fully accredited by the Liaison Committee on Medical Education and the Higher Learning Commission. The medical school offers a comprehensive, innovative four-year Doctor of Medicine degree program and a Master of Science degree program in Biomedical Sciences. We train physicians in 10 residencies and five fellowships accredited by the Accreditation Council for Graduate Medical Education. To support our educational mission, we have Joint Accreditation for interprofessional continuing education, which incorporates accreditation by the Accreditation Council for Continuing Medical Education.

WMed Health is the clinical practice of the medical school with more than 300 providers offering comprehensive primary care and specialty services in several locations throughout the Kalamazoo and Battle Creek areas. Faculty in the Department of Pathology serve as the Office of the Medical Examiner for counties throughout Michigan and northern Indiana.

The W.E. Upjohn M.D. Campus located in downtown Kalamazoo serves as the primary educational facility with student study and social spaces, team-based learning halls, faculty and administrative offices, a state-of-the-art Simulation Center accredited by the Society for Simulation in Healthcare, basic science research labs, as well as toxicology and forensic pathology labs.

WMed builds upon Kalamazoo’s century-long foundation of drug discovery and medical device development with a strategic investment in clinical, laboratory, community, and educational research. The Center for Immunobiology, Center for Clinical Research, Research Histology Lab, Innovation Center, and Human Research Protection Program contribute to the medical school’s advancement of knowledge through innovation and discovery. 

Equal Employment Opportunity Employer in compliance with applicable State and Federal law.