WMU Homer Stryker MD School of Medicine (WMed) is seeking a Research Integrity Specialist. The position assists in the administration of three distinct but overlapping areas:  Institutional Animal Care and Use Committee (IACUC); Institutional Biosafety Committee (IBC); and the Controlled Substances program in Research. The Research Integrity Specialist manages the day-to-day operations of the committees, overseeing IACUC protocol submissions and IBC registrations, and facilitation of the IACUC/IBC meetings using WMed’s electronic submission software system (IRIS).

•  Institutional Biosafety Committee- The IBC is a compliance committee that ensures research is conducted safely and in compliance with the National Institute of Health’s (NIH) Guidelines for Research with Recombinant or Synthetic Nucleic Acid Molecules. The IBC is responsible for reviewing applications from faculty members for research with hazardous biological agents including recombinant DNA to assess whether the biosafety containment level proposed is adequate to protect workers, the public, and the environment from risks posed by the work. In conjunction with the Radiation Safety Officer (RSO), the IBC also oversees research projects with radioactive materials.
• Institutional Animal Care and Use Committee-The IACUC is a research compliance committee required by federal regulations for institutions that use animals in research, teaching and testing. The IACUC is responsible for review and approval of animal use activities with vertebrate animals and inspection of animal facilities. The animal care and use program is fully accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) and has an assurance with the NIH Office of Laboratory Animal Welfare (OLAW) to receive Public Health Service (PHS) funding. 
• Controlled substances program in research- WMed researchers who obtain, store and utilize controlled substances in their research must comply with all relevant state and Federal regulations. Responsibilities of the Research Integrity Specialist include training, monitoring and review of records to help identify any corrective actions needed to prevent problems in the event of an audit by the State of Michigan (SOM) Licensing and Regulations Affairs (MiLARA) or Drug Enforcement Agency (DEA). 

The Research Integrity Specialist accomplishes a wide variety of tasks with considerable independence and must exercise discretion in applying policies and procedures using professional judgement, demeanor, and in a manner that promotes a positive image of Research Compliance.

• Manages IACUC and IBC committee meetings by working with the Chairs to develop meeting agendas, attending meetings and preparing meeting minutes, and additional committee meeting functions as assigned.
• Conducting administrative reviews or pre-screening IACUC protocols and IBC registrations to bring them into compliance with minimum review standards and administering and verifying Conflict of Interest before protocols are distributed to the IACUC or IBC committees.
• Provides advice to investigators and research team members in preparation of applications or registrations for research proposals involving animals and biological materials
• Assists in the preparation of decision letters to investigators (on behalf of the IACUC/IBC Chairs) after meetings on the outcome of the research protocols and may independently follow-up on action items from the meetings.
• Assists with development of procedures and guidance for IBC and IACUC administration, including standard operating procedures and guidance materials for investigators, and research staff and the WMed research community.
• Develop, coordinate and track IACUC/IBC training documents for committee members.
• Perform congruence reviews between IBC registrations and IACUC protocols, and assist in reviewing Material Transfer Agreements (MTAs) for compliance.
• Assist in facilitation of the Quality Assurance Program and/or Post Approval Monitoring (PAM) program to strengthen a collaborative partnership between researchers and research compliance.
• Develops, coordinates and tracks IACUC/IBC training documents for committee members.
• Oversees WMed’s controlled substances program for research to ensure compliance with the State of Michigan MiLARA licensee and DEA registration requirements (e.g., acquisition, receipt, delivery, security, reporting (inventory), and disposal of controlled substances for nonhuman use).
• Assist in facilitation of the Quality Assurance Program and/or Post Approval Monitoring (PAM) program for IBC and IACUC protocols.
• Availability to work on weekends and evenings to complete time sensitive projects.
• Acquires knowledge for new technology and policy/procedure revisions
• Work on projects and initiatives related to IBC and IACUC and other areas of research compliance as assigned.
• All other duties as assigned.

EDUCATION AND/OR EXPERIENCE: 

• Bachelor’s degree in a related scientific discipline (e.g., biology, chemistry, biochemistry, microbiology or molecular biology).
• Four years of related experience.
• Experience working for or with an IBC, IACUC or another research compliance committee.
• Ability to understand biological, chemical and scientific terminology and procedures, and to accurately identify drugs, devices, procedures, recombinant technology, infectious agents and toxins in order to provide a through and accurate protocol review.
• Ability to read and comprehend complex scientific procedures in order to provide thorough, accurate and self-sufficient protocol review.
• Experience working as a productive and collaborative member of a team.

LICENSES, REGISTRATIONS, CERTIFICATIONS: 

• Have or obtain within 2 years of hire applicable or related certification such as CIP, CPIA, ABSA or SoCRA.

OTHER SKILLS AND ABILITIES: 

• Advanced knowledge in federal and state laws, regulations, policies and Standard Operating Procedures (SOPs) to ensure institutional compliance.
• Demonstrates the ability to recognize priorities in organization of work flow.
• Must be detail oriented and have the ability to multi-task and work cooperatively with others or independently when needed. Ability to deliver quality professional products in a timely manner.
• Demonstrated ability to communicate effectively in oral and written format.
• Advanced skills with Microsoft including data management skills in Excel.
• Demonstrated ability to organize and manage databases.
• Experience with an online application system for research compliance committee submissions.
• Ability to travel locally between WMed sites.
• Demonstrate 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. 

Western Michigan University Homer Stryker M.D. School of Medicine is an Equal Employment Opportunity/Affirmative Action employer of females, minorities, individuals with disabilities, and protected veterans, and actively strives to increase diversity within its community. We provide a drug- and tobacco-free workplace. 

EEO Minorities/Women/Disabled/Protected Veterans.