The Office of the Vice Provost for Research has a great opportunity for an Executive Director, HSRO at the University of Miami medical campus.
The Executive Director is responsible for the leadership, oversight and management of the University of Miami (UM) Human Subject Research Office (HSRO) and Institutional Review Boards (IRBs). The Executive Director reports to the Vice Provost for Research, who also serves as the Institutional Official. The Executive Director is responsible for providing leadership and vision for the HSRO/IRBs, oversees development and implementation of policies, procedures and programs in compliance with federal regulations, state laws and Institutional polices. Develops and maintains collaborative relationships with internal and external stakeholders, establishes a culture of respect for human research participants, ensures timely and thorough review and approval of research protocols; and assures that education and training programs for the HSRO, IRB, and research community are up to date and effective.
CORE JOB FUNCTIONS
Collaborates with UM Human Research Protection Program (HRPP) partners, establishes processes to ensure that the HRPP mission and goals are attained while facilitating a seamless approach to human subject protection and human subject research administration. Works with the Institutional Official continually to assess whether the HRPP is appropriately protecting research participants in light of new research models, and develop strategic plans to adapt to new environments. Serves as the lead contact for reviews and inquiries from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Assesses HRPP policies and practices for alignment with federal and state regulations, local laws, Institutional policies, AAHRPP accreditation standards and best ethical practices related to human subjects research. Ensures that Federal-Wide Assurances and Institutional Review Board (IRB) registrations are submitted appropriately. Evaluates external organizations or investigators for reliance upon the UM IRBs to review human research projects and ensure that appropriate agreements are enacted and maintained in accordance with requirements. Evaluates UM IRB and central IRB models for human subjects research. Ensures efficient and compliant processes for review, approval and oversight of human research performed by the UM IRBs. Provides consultation and advices UM IRB Chairs and members, including regulatory and ethical advice on the review of ethically and scientifically complex research. Oversees the management of inquiries, reports, IRB findings and responses regarding unanticipated problems involving risks to participants and others and serious or continuing non-compliance; assist in identifying corrective actions to ensure the protection of human subjects and compliance with institutional policy. Ensures the development and implementation of educational and training materials and activities for faculty, research staff, IRB members and HSRO staff to ensure an understanding of human research rights and obligations. Oversees, manages, and evaluates the day-to-day activities of the HSRO staff; defining administrative structure and staff responsibilities. Assesses existing and future program needs. Establishes strategic plans developing goals and objectives for the HSRO/IRB and metrics for their evaluation. Ensures that HSRO data management systems are effective and appropriately interfaced with other University systems and department applications. Develops and maintains administrative processes and systems that support the UM IRBs and research community. Ensures the periodic performance review of the IRB membership and composition to maintain a diverse spectrum of qualified individuals. Assists in recruiting prospective IRB chairs and members and make recommendations to Institutional Official. Assesses the number of IRB committees and frequency of IRB meetings to ensure growth in the research enterprise is met with timely IRB committee review and approval. Works with UM leadership to contribute to national policies related to protection of human research participants. Prepares and presents to the Institutional Official an annual report summarizing HSRO/IRB goals and accomplishments of the year, as well as goals for the upcoming year. Works with the Senior Manager of Finance and Director of Business Operations to prepare and oversee the HSRO’s annual budget. In conjunction with Research Information Technology, HSRO staff, and the Institutional Official, oversees the IRB protocol management system. Oversees training and support for all IRB system users. Works with the Institutional Official, the leadership of the Miller School of Medicine, and the office of Research Compliance and Quality Assurance to develop and maintain a clear set of policies and guidelines for the operations of the HSRO and the IRB.
Master’s Degree in in an appropriate scientific, legal or business discipline: e.g., J.D., M.S., M.B.A. or Ph.D.
Certification and Licensing:
Certified IRB Professional (CIP) preferred
- Minimum 7 years of relevant experience in IRB-related activities with four years in a supervisory capacity.
- Prior experience in HRPP administration. Expert knowledge in federal, relevant international and state human subject regulations.
- Proven experience working collaboratively with researchers, federal authorities and Board members.
- Experience with administering and overseeing human subjects electronic management systems strongly preferred.
- Preferred: HRPP and IRB experience in a university or academic medical center setting; research administration experience in a compliance and/or regulatory environment; experience with and thorough knowledge of Institutional policies regarding the protection of human subjects participating in research; experience in presenting professional seminars or lectures at the national conference level, experience with national organizations concerned with the protection of human subjects.
Knowledge, Skills and Attitudes:
- Demonstrated leadership, management, operations and problem-solving skills.
- Demonstrated oral and written communication skills.
- Demonstrated ability to work effectively with other Institutional entities within the HRPP.
- Open and candid individual with excellent diplomatic and negotiating skills
- Demonstrated commitment to the principles underlying UM’s cultural values and service standards
- Experience with standard office software applications.
The University of Miami is home to some of the brightest minds in the world. We are committed to educating and nurturing students, creating knowledge, and providing service to our community and beyond. The University of Miami offers competitive salaries and a comprehensive benefits package including medical and dental benefits, tuition remission, vacation, paid holidays and much more. The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information-https://www.hr.miami.edu/careers/employment-laws-eo/index.html]]>