Director, Office for the Protection of Human Subjects and Institutional Review Board

The Office of the Vice President for Research (OVPR) for is seeking a Director, Office for Human Subjects Protection and Institutional Review Boards (OHSP).

OHSP ensures compliance with applicable federal and local laws and regulations, as well as adherence to professional and ethical standards, institutional policies and procedures and observance of good practice quality guidelines (GxP) as they apply to research involving human subjects. The Director, OHSP reports directly to the Associate Vice President for Research Integrity and is responsible for managing all business of the OHSP.

Specific responsibilities include:

Oversight, administration and coordination of all human resources, administrative, and training activities of the OHSP and Institutional Review Boards (IRB) with the goals of improving the safe and efficient conduct of research, reduce the administrative burden by improving operational efficiency, accelerate protocol review and decision review and turnaround times by improving review practices.

The Director will develop policies and procedures and ensure stakeholders are trained in the policies and procedures and following them.

Monitor and analyze current and proposed federal and local regulations and policies and recommend changes in institutional policies and procedures to ensure compliance.

Facilitate the submission of the Association of Accreditation of Human Research Protection Programs (AAHRPP) accreditation application within one year of hire.

Monitor publications, reports and related information on new/revised regulations on human subject protections and maintains professional knowledge/skills by attending seminars, workshops and the review of published literature. Provides input into the IRBweb page as well as education and training materials.

Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

Minimum Qualifications:

Qualified candidates will hold a Bachelor’s degree in an appropriate area of specialization plus 8 years of relevant professional experience, or, a Master’s degree or higher in a relevant area of study plus 6 years of relevant professional experience. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.

Preferred Qualifications:

JD, or PhD strongly preferred

Certified IRB Professional (CIP) or Certified IRB Manager (CIM)

5 years management experience

8 years experience in human subjects research

Progressive relevant experience in a federally funded research organization overseeing regulatory committee operations included direct experience involving biomedical research and clinical trials.

Experience with AAHRPP accreditation process

Experience managing electronic regulatory committee submission and review systems

Proven ability to manage relationships with researchers, staff and regulatory agencies

Experience in balancing regulatory compliance requirements against practical needs and limitations

Ability to lead change

The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.