Senior Director, Research Compliance

Overview

Western Michigan University Homer Stryker M.D. School of Medicine is recruiting for a Senior Director, Research Compliance. The Senior Director for Research Compliance provides coordination for the administration, support, and monitoring of regulatory committees and activities including the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC) and the Institutional Biosafety Committee (IBC). The Senior Director for Research Compliance has the responsibility to oversee the administration of policies and regulations mandated by federal and state law in the areas of human subject’s protection, animal welfare regulations, radiation safety, biosafety, research conflict of interest and controlled substances in research.  The position oversees the overall operations of Sponsored Programs Administration which includes proposal development, budget creation, grant management and compliance.

The Senior Director for Research Compliance demonstrates the highest level of personal and professional commitment, enthusiasm, integrity, and support of the medical school and its mission, vision, and values; aligns with and supports all aspects of the medical school; and strives to achieve excellence in all aspects of operations.

Responsibilities

• Directs and oversees the administration of research compliance services and programs, including human research protections, conflict of interest, Institutional Review Board (IRB), Institutional Animal Use and Care Committee (IACUC), Institutional Biosafety Committee, Radiation Safety, Export Control and other committees as identified.
• Serves as signing official for research agreements including grant submissions, grant agreements and material transfer agreements as delegated by senior leadership.
• Build and preserve a culture of research compliance at WMed.
• Maintain the continuous quality improvement and post monitoring activities within the department of research compliance.
• Oversees the management of research compliance staff in their efforts to secure and maintain Association for the Accreditation of Human Research Protection Program (AAHRPP) and Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).
• Serves as the primary point of contact for internal and external groups and organizations related to research compliance.
• Acts as the Clinical Laboratory Improvement Amendments (CLIA) for sponsored research at WMed.
• Provide strong leadership in identifying, developing relations with, and securing extramural support from appropriate governmental agencies, private foundations, and business and industry in support of WMed research programs.
• Coordinate the dissemination of information related to federal, state, and private sector support and opportunities for grant funding.
• Assist IT staff in the development and deployment of effective electronic research administration systems. Promote the effective and efficient utilization of electronic systems for grant proposal submission.
• Foster internal and external communication regarding the research activities of the institution and promote the medical school to its various public and private constituencies in research and scholarly activities.
• Oversee the implementation of policies regarding patents, copyrights, and intellectual property rights in research agreements with private sponsors, as well as in faculty/staff interests related to these matters.
• Availability to work occasional overtime on weekends or evenings to complete time sensitive projects.
• Acquires knowledge for new technology and policy/procedure revisions.
• All other duties as assigned.

Qualifications

EDUCATION AND/OR EXPERIENCE:

• Master’s degree in a relevant field from an accredited institution.  Terminal degree preferred.  
• Minimum of 10 years’ experience with progressively responsible experience in a leadership position in sponsored research administration in a university or medical center required.
• Proven success in directing the work of a large staff and providing effective management of external funding.
• Experience in grant proposal development and post award management.
• Knowledge and practical application of regulations related to USDA, FDA, Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) and other relevant guidelines.

LICENSES, REGISTRATIONS, CERTIFICATIONS:

• Current NIH or Citi training.

OTHER SKILLS AND ABILITIES:

• Strong critical thinking skills and the ability to analyze summarize and effectively present data.
• Exceptional interpersonal skills and the ability to interact effectively with academic leadership, faculty, community leadership, and funding agencies.
• Strategic planning skills.
• Knowledge of organizational structure, workflow, and operating procedures.
• Ability to foster a cooperative work environment.
• Employment development and performance management skills.
• Knowledge and understanding of institutional policies and procedures and the regulatory environment within which they operate.
• Ability to perform complex tasks and to prioritize multiple projects.
• Demonstrated leadership, organizational and management skills.
• Ability to supervise and train assigned staff including organizing, prioritizing and scheduling work assignments.
• 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-centered care, innovative research, and community partnerships within a welcoming, supportive, and engaging culture. 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, with an estimated annual 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 as well as a Master of Science degree program in Biomedical Sciences. We train physicians in 10 residencies and four 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.