WMU Homer Stryker M.D. School of Medicine

Research Compliance Administrator

Job Locations US-MI-Kalamazoo
Posted Date 5 days ago(9/21/2021 9:35 AM)
Job ID
2021-1743
# of Openings
1
Category
Research
Target Salary
61,100-76,360

Overview

Western Michigan University Homer Stryker M.D. School of Medicine is seeking a Research Compliance Administrator.  Maintaining high ethical standards in research is vital to upholding the medical school’s mission, vision and values. Our compliance team supports the medical school’s continued compliance efforts by helping students, residents, faculty and staff understand their obligations under applicable governmental regulations and university policies.  The Research Compliance Administrator plays a key role in ensuring compliance with regulations governing research and other qualifying activities that involve human participants, animals, and/or biohazardous materials.

Responsibilities

  • Assists with the development of institutional policies, procedures, guidelines, and programs that enable the conduct of research while ensuring compliance with regulatory requirements.
  • Assistance or delivery of training and communications to facilitate regulatory compliance, foster a culture of research integrity, promote responsible conduct of research (RCR) initiatives, and provide regulatory expertise & guidance to support the WMed research community.
  • Conducts routine internal incident investigations and follow up including the development and monitoring of corrective actions.
  • Participates in investigation of matters related to compliance, including designing and coordinating internal investigations and any resulting corrective action.
  • Oversees and monitors the implementation of specific compliance program elements.
  • Maintains current knowledge of the application of federal and state laws, regulations and policies relevant to area of expertise such as, the Health Insurance Portability and Accountability Act (HIPAA), the Medicare Clinical Trial Policy, the Federal Policy for the Protection of Human Subjects (the Common Rule), the FDA regulations for the conduct of human subject research (Title 21 CFR), the PHS Policies on Research Misconduct, the PHS Policy on Humane Care and Use of Laboratory Animals and enhances professional growth and development by participating in educational programs relating to such topics.
  • Assists Research Integrity Officer with research misconduct inquiries and investigations.
  • Supports WMed with performance of other compliance-related duties as requested.
  • Provides guidance to staff, researchers, and other medical school departments related to complex research protocols.
  • Creates the content for and maintains the compliance and integrity section of the research services website.
  • Serves as a resource for researchers and staff; provides guidance and consultation in key compliance review processes and complex federal regulations in order to facilitate WMed research.
  • Availability to work on weekends and evenings to complete time sensitive projects.
  • All other duties as assigned.

Qualifications

  • Secondary degree (Masters, JD) in a field related to policy or research, or a bachelor’s degree plus at least 5 years of experience in research compliance working with IRB, IACUC and/or IBC, preferably in an academic setting.
  • Experience in working with IACUC and or animal care and use program.
  • Experience in an active research setting that included human subjects research with a working knowledge of the Common Rule, FDA regulations and ICH GCP.
  • Experience with Federal reporting criteria and submission systems.
  • Experience with SharePoint and maintaining a website.
  • Ability to assess existing medical school operations to determine the need for new or enhanced policies and procedures.
  • Ability to support and promote an effective, ongoing regulatory compliance program.
  • Thorough knowledge of compliance issues, laws and regulations relating to research compliance.
  • Ability to lead and manage projects.
  • Ability to work independently on multiple issues concurrently and to exercise independent judgment in establishing priorities.

LICENSES, REGISTRATIONS, CERTIFICATIONS: 

Current Certified IRB Professional (CIP) and Certified Professional IACUC Administrator (CPIA), or willingness to obtain certification within 2 years.

 

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

 

Western Michigan University Homer Stryker M.D. School of Medicine (WMed) is an exciting environment to pursue and academic career. 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 501(c)(3) nonprofit corporation supported by private gifts, clinical revenues, research activities, tuition, and endowment income. Building upon the $100 million foundational gift in 2011, WMed received a philanthropic commitment of $300 million to support the mission of the medical school in June 2021. WMed contributed to the creation of 1,600 new jobs and an economic impact of $353 million in Kalamazoo and Calhoun counties in 2020.

 

WMed is fully accredited by the Liaison Committee on Medical Education and the Higher Learning Commission. WMed offers a comprehensive, innovative four-year Doctor of Medicine degree program and two Master of Science degree programs in Biomedical Sciences and Medical Engineering. There are more than 200 residents and fellows in 10 residencies and five fellowships accredited by the Accreditation Council for Graduate Medical Education. To support its mission to educate and inspire lifelong learners, WMed has 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 Kalamazoo, Portage, and Battle Creek. The Department of Pathology faculty 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 faculty and administrative offices, student study and social spaces, team-based learning halls, 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 is building 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, WMed ForenTox, Research Histology Lab, Innovation Center, Division of Epidemiology and Biostatistics, 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.

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