Job# 11659 Assistant Vice President for Research Regulatory Compliance
Job Description
Job# 11659 Assistant Vice President for Research Regulatory Compliance
POSITION OBJECTIVE
Provide leadership and contributes to strategic planning for research regulatory compliance for Case Western Reserve University. The
Assistant Vice President is the strategic leader for developing and maintaining compliant, efficient, and effective policies and processes
for research regulatory responsibilities to ensure that our regulatory committees and activities adhere to university and sponsor
regulations. The assistant vice president is responsible for developing and maintaining efficient and effective regulatory committees and
activities including the Institutional Review Board, the Institutional Animal Care and Use Committee, the Institutional Biosafety Committee,
the Institutional Review Entity for Dual Use Research of Concern, the Human Stem Cell Oversight Committee and Export Control. TheAssistant Vice President is responsible for developing and implementing a long-range strategic plan to enhance operations
of all research regulatory committees, so they adhere to all federal, state, and local regulations while supporting faculty to secure
approvals in a timely fashion. The assistant vice president plays an integral role within the university’s
Research Administration leadership team and will serve as an advisor to senior leadership on matters related to regulatory activities.
The assistant vice president will provide leadership and ensure good working relationships with the university’s affiliated hospitals,
which include University Hospitals Cleveland Medical Center, MetroHealth Medical Center, VA Northeast Ohio Healthcare System, and the
Cleveland Clinic Foundation. This position will supervise a regulatory compliance unit of 13 and directly supervise three executive
directors and two managers.
ESSENTIAL FUNCTIONS
- Serve as a pivotal member of the Research
Administration leadership team. Responsible for overseeing non-financial regulatory responsibilities of the university. Serve as a leader in
the development of strategic planning for regulatory compliance in collaboration with leadership in the Office of Research Administration.
Serve in an advisory role to the associate vice president for research and the senior vice president for research and technology management.
(20%) - Direct and oversee the Institutional Review Board, the Institutional Animal Care and Use Committee, the Institutional
Biosafety Committee, the Institutional Review Entity for Dual Use Research of Concern, the Human Stem Cell Oversight Committee and Export
Control such that these committees provide efficient and effective service to faculty and staff engaged in pursuing research requiring
regulatory approval. Facilitate long-range strategic planning, compliance oversight, and development and maintenance of policies and
procedures for the regulatory committees. Ensure that sponsoring agencies and university policies and procedures are followed. Stay current
on regulatory and legal issues relating to regulatory compliance. (15%) - Ensure that each regulatory committee provides faculty and
staff information and resources to ensure they are knowledgeable of regulatory requirements. Develop and implement polices for the
submission and review of protocols to all regulatory committees so that protocols are reviewed and approved as appropriate in a timely
fashion so as not to delay research progress. Develop and disseminate communications that occur with regulatory agencies on the implications
of current and proposed policies and procedures. Provide vision and university-wide leadership in establishing and maintaining effective
systems of for the management of university regulatory requirements. In collaboration with the Assistant Vice President for Research
Integrity and Training develop and continually update comprehensive training for users of all regulatory committees as well as standardized
formal training for regulatory committee staff members. (15%) - Serve as the University Research Compliance Officer. Analyze current
areas of risk to the university with respect to regulatory. Develop and implement a Regulatory Compliance Monitoring Program to
systematically monitor research programs to ensure that regulatory requirement is being followed. Work with executive directors to address
regulatory issues as they are discovered. Develop processes to ensure that all university investigators are compliance with Clinical
Trials.gov reporting requirements. Serve as member of the University Compliance Committee and various other university committees to
represent the university office for Research Administration and Technology Management. Develop and manage the Quality Improvement Review
Program for the HRPP. Provide oversight to the program administrator for the administrative, training and compliance and business processes
of the IRB Quality Improvement Review Program. Develop evolving policies and procedures for the audit and oversight of research conducted
under regulatory requirements. Provide oversight of the audits carried out by the manager. Oversee Quality Improvement Review Program goals
to meet national accreditation standards to facilitate and maintain the accreditation of the HRPP. Research and interpret trends and new
developments in the federal regulatory and compliance area pertaining to investigator conduct of research. Develop strategies to enable the
university to successfully adapt to changes. Regularly communicate and disseminate appropriate information. (15%) - This position
serves as the lead for the strengthening of our relationship with our affiliate hospitals regarding regulatory compliance to develop
processes to ensure that faculty are able to conduct research across institutions efficiently. Serve as the Administrator for the IAC and
acts on behalf of the IAC Chair in his/her absence. Provide strategic planning mechanisms to ensure utmost function of the IRB Advisory
Committee. Help to provide expertise in human subjects research and promote harmonization between the IRBs and their common processes.
Strategically plan working relationship with faculty members, staff and students in promoting their research and moving it forward in the
CWRU IRB SpartaIRB system and utilization of the Reliant Review Program. (15%) - Direct institutional efforts to meet compliance
needs. Serve as an expert for executive directors as they conduct investigations of allegation of regulatory non-compliance. Work with the
executive directors and investigators to report compliance matters to the appropriate agencies. Acts as a liaison between university and
regulatory agencies. Advise executive directors on various definitions for non-compliance. Notify the vice president and associate vice
president for research if a study is federally funded and the regulatory committees find events to be a matter of serious and/or continuing
non-compliance. Support the crafting of the letter to regulatory agencies. Directly report to appropriate Institutional and federal
government officials as required by federal regulations. Work with senior vice president and associate vice president for research as well
as the associate deans for research to establish good working relationships and advise them on compliance matters. Act as regulatory expert
regarding compliance matters and give advice regarding the federal regulations, state laws, and local policies. Serve as member of the
university Compliance Committee and various other university committees to represent the university office for Research Administration and
Technology Management. (15%) - Develop a national presence for CWRU in the research regulatory community. See roles in national
organizations and actively pursue opportunities for engagement with other university leaders. (5%)
NONESSENTIAL
FUNCTIONS
Perform other duties as assigned. (<1%)
CONTACTS
Department: Regular contact
with the associate vice president for research and will also have daily contact with executive directors of research compliance committees
to coordinate university’s response to ever-changing regulatory department.
University: Regular contact with university
faculty, staff and students, school research administration departments
External: Frequent contact with regulatory, accreditation,
and professional societies involved with human subjects research protections.
Students: Infrequent contact with students.
SUPERVISORY RESPONSIBILITY
Supervise three executive directors and two managers.
QUALIFICATIONS
Experience: 10 years of experience in academic/grant-based environment is required. Five years in
a managerial position is required. Oversight of regulatory committees required.
Education: Master’s degree in a health-related
or administrative field is required.
REQUIRED SKILLS
- Technical and administrative leadership skills to
analyze, evaluate, and communicate matters relating to areas of research compliance. - Demonstrated success directing staff and
delivering services to faculty. - Demonstrated success in management of people and delegation of tasks.
- In depth knowledge
of federal, state and city and other sponsor regulations governing grant and contract administration and research compliance. - Ability in conflict resolution.
- Ability to develop strategies to enable the University to anticipate and successfully adapt to
the changes in sponsor requirements and business practices. - Superior communication, writing, and personal skills with the
demonstrated ability to communicate with disparate constituencies and to bring together diverse agendas to achieve common goals. - Good understanding of information systems and their capacity to facilitate workflow and communication as it relates to the activities
within research-oriented enterprises. - Demonstrated skill in encouraging cooperation, strengthening the quality of the response to a
multiple and diverse research community, and achieving optimal use of resources. - Solid conceptual skills with excellent attention
to detail. - Creativity, vision, integrity, and exceptional energy.
- High degree of integrity essential. Ability to meet
consistent attendance. - Ability to interact with colleagues, supervisors, and customers face to face.
- Must be a highly
competent administrator and innovator who will enhance the office and its processes to make them more efficient and effective and who can
work as a team member to accomplish departmental and institutional goals.
WORKING CONDITIONS
No health
or safety hazards are present. There will be some pressures arising from large workload, deadlines, frequent disruptions, and changes in
priorities.
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