WMU Homer Stryker M.D. School of Medicine

Director, Human Research Protection Program

US-MI-Kalamazoo
1 month ago(12/15/2017 8:50 AM)
Job ID
2017-1278
# of Openings
1
Category
Administrative/Clerical
Target Salary
NA

Overview

The Director of the Human Research Protection Program (HRPP) is responsible for ensuring that WMed’s Human Research Protection Program complies with all applicable laws, regulations and policies, including standards of excellence necessary for obtaining and maintaining accreditation. The Director, HRPP will oversee the development and implementation of best policies and processes in support of strategies for the regulatory portion of the HRPP with a focus on review and regulatory management of studies involving human subjects and the Institutional Review Board (IRB).

Responsibilities

  • Create and foster an environment of support for the research community.
  • Provides organization, direction, and integrative coordination in the planning, development, and implementation of the HRPP, under the direction of the associate dean for Research Compliance.
  • Establish short- and long-range goals and objectives, and develop strategic plans, policies, and operating procedures to increase clinical research that adheres to the highest ethical standards in the protection of human research participants.
  • Design, implement, and evaluate processes, organization, and staffing to effectively accomplish the goals and objectives of the HRPP.
  • Hire, train, and supervise staff to support the HRPP.
  • Manages the development, drafting and/or revision of the HRPP/IRB handbook as well as other policies and processes as required.
  • Direct the establishment and maintenance of essentials records and files related to human subjects research.
  • Monitor and evaluate operational effectiveness and implement changes required for improvement.
  • Establish and maintain effective communication and cooperative working relationships with medical school administrators, faculty, staff, and government and private agencies.
  • Serve as principal point of collaboration, leadership, and expertise for the HRPP to both internal constituencies (laboratory, pharmacy, medical records, conflict of interest and commitment compliance, IACUC, IBC, Radiation Safety) and external constituencies on professional and operational matters pertaining to the HRPP.
  • Act as liaison with the Director of Sponsored Programs Administration (SPA), IRB, Chief Compliance Officer (Associate Dean for Administration and Finance), and Compliance Committee, assuring compliance with regulations and national standards for human subjects research.
  • Develop and maintain positive relationships with federal and state agencies, collaborating organizations, investigators, and staff.
  • Maintain a current knowledge and interpret and apply federal and state laws, regulations, and guidelines governing human subjects research.
  • Work closely with medical school leadership, hospital leadership, and leadership at affiliated entities to ensure compliance with the ethical and regulatory requirements for human subjects research.
  • Implement and oversee meeting all standards to achieve and maintain HRPP accreditation.
  • Evaluate, and modify technical and administrative IRB and other review processes and internal research auditing policies, protocols, systems, and procedures in accordance with government and medical school requirements.
  • Prepare and present IRB, research and clinical study audit reports and summaries, including monthly and annual reports to the administration, researchers, and IRB.
  • Serves as the administrator for IRB software (IMedris). Incumbent is responsible for developing forms and templates within the software ensuring accurate input of information.
  • Serves as the administrator for the online human subjects protection educational program (CITI).
  • Oversee the development and delivery of targeted training programs and materials based on IRB reviews, research and clinical study audit results, as well as on changes to legislative, statutory, and medical school requirements.
  • Oversee the development of training materials and guides to assist faculty and staff in human subjects research.
  • Oversee the HRPP component of the website.
  • Assist with training lectures and events for new faculty, staff, and administrators in the medical school procedures for human subjects research.
  • Provide advice, guidance, and problem resolution to research investigators and staff in the application of relevant federal and state laws, regulations, and guidelines.
  • Assist with specific inquiries related to scientific misconduct and IRB-related non-compliance issues, as requested.
  • Observe all health and safety requirements.
  • Participate in educational and professional conferences and meetings.
  • Serve on appropriate medical school committees as required.
  • Availability to work occasional overtime on weekends or evenings to complete time sensitive projects.
  • Acquires knowledge for new technology and policy/procedure revisions.
  • Perform other duties as assigned.

Qualifications

  • Bachelor's degree plus at least five (5) years of progressive work experience supervising or conducting human research with increasing responsibility in a human subject’s protection program; OR
  • Master's degree plus at least three (3) years of progressive work experience supervising or conducting human research with increasing responsibility in a human subject’s protection program.
  • Strong knowledge of DHHS and FDA human subjects’ regulations and related guidance and ethical principles.
  • Familiarity with other regulations and standards (e.g. HIPPA, FERPA) that maybe applicable in some human subjects research.
  • Experience with scientific and medical concepts, terminology, and clinical care procedures and standards.
  • Knowledge of HIPAA regulations and state laws governing privacy.
  • Knowledge of Association for Accreditation of Human Research Protection Programs (AAHRPP) standards and accreditation requirements; experience in an AAHRPP-accredited institution preferred.
  • Research experience within both an academic and hospital setting, preferred.
  • Previous management/supervisory experience with demonstrated success in leading and managing people is required.
  • Strong leadership and team building skills and experience working collaboratively.
  • Certified IRB Professional (CIP) or other appropriate certification preferred.

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

 

As one of the newer US medical schools, WMed is an exciting environment to pursue an academic career. The medical school is a collaboration of Western Michigan University, which ranks among the 50 largest colleges and universities and among the top 100 national public doctoral universities in the US, and Kalamazoo's two teaching hospitals, Borgess Health 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. The program leading to the MD degree was accredited by the Liaison Committee on Medical Education in 2012, and the inaugural class began in 2014. The School of Medicine Clinics are housed in a modern 60,000 square foot clinical building on the Oakland Drive Campus and are accredited by The Joint Commission with recognition by National Committee for Quality Assurance (NCQA) as a Patient-Centered Medical Home. The 350,000 square foot educational building on the W.E. Upjohn M.D. Campus located in downtown Kalamazoo underwent a $68 million renovation and expansion project including a state-of-the-art Simulation Center. In 2016, an additional $10 million expansion created two floors supporting clinical and laboratory research, and the Innovation Center on the Parkview Campus became part of the medical school. There are more than 200 residents and fellows in eight residencies and two fellowships accredited by the Accreditation Council for Graduate Medical Education (ACGME). WMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) for continuing medical education.

 

Kalamazoo is a wonderful and vibrant city, located midway between Chicago and Detroit. It is a short distance from Lake Michigan, and home to two nationally ranked institutions of higher learning, Western Michigan University and Kalamazoo College. Kalamazoo is known for its community focus and emphasis on access to quality education at all levels. The Kalamazoo Promise is a nationally renowned program in which graduates of Kalamazoo Public Schools receive free tuition to attend public and private colleges in Michigan. At the other end of the educational continuum, the Kalamazoo Ready 4s program ensures that every 4-year-old in Kalamazoo County has the opportunity to attend a high-quality pre-kindergarten program, regardless of ability to pay. Kalamazoo and Michigan provide extensive entertainment and recreational activities, including opportunities to enjoy the outdoors, unique restaurants and shops, and a strong culture supporting the arts.

 

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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