Director of Office of Human Subjects
Job ID: 42470
Full/Part Time: Full-Time
Apply On Or Before: 01/01/9999
The Office of Research at Florida State University seeks to fill the position of Director of the Office of Human Subjects.
The Office of Human Subjects is responsible for the operational management and administration of the Institutional Review Board (IRB). The IRB is a committee of scientists and laypersons who review all proposed FSU human subjects research to ensure that the safety and welfare of subjects are protected. This position is responsible for facilitating the use of the IRB and administering FSU’s compliance with the applicable rules and regulations regarding human subjects. Reports to the Vice President for Research and provides leadership for university relationships with other institutions, compliance offices, and their staff.
The Director of the Office of Human Subject’s primary responsibility is to manage the administrative operations of the IRB, including supervising staff and managing the operating budget. Additional responsibilities include:
- Ensuring fully documented compliance with all IRB directives, rules, and regulations.
- Working with the IRB Chair to develop and maintain IRB procedures.
- Preparing materials for Federal Wide Assurance document and documents that are required by OHRP and the FDA for review by the Vice President for Research.
- Serving as the initial contact for auditors and informing the appropriate university officials of such visits/audits.
- Ensuring compliance with the sunshine and open record laws while protecting the confidentiality of research proprietary information.
- Working with Legal Counsel and the Director of Compliance regarding regulatory issues, policies, noncompliance, and subject complaints.
- Informing the Vice President for Research of regulatory risk, issues, and noncompliance. If necessary, implementing institutional corrective action.
- Developing, planning, and implementing programs to inform investigators, including new faculty and IRB members, of the required procedures and formats for research proposals that involve human subjects, as well as providing resources and continuing education offerings.
- Working with Legal Counsel, the Director of Compliance, and the VP for Research to address international research and entering into IRB authorization agreements with other institutions.
- Analyzing opportunities to improve services and implement enhancements in order to facilitate research and provide superior customer service.
Master’s degree and six years of experience related to a senior Institutional Review Board/Human Subjects management position. (Note: higher education can substitute for experience at the equivalent rate.)
Knowledge of Federal laws, regulations and policies pertaining to human subjects research.
Ability to adhere to ethical business practices and promote ethical behavior.
Knowledge of and the ability to apply the principles and practices to strategically align tasks and people with organizational goals and objectives.
Ability to communicate effectively verbally and in writing.
Ability to establish and maintain effective working relationships.
Ability to represent the University in appointed area as required.
Ability to strategically plan and serve as a catalyst for organizational change, cultivate a shared vision with others, and motivate others to transfer vision into action.
Knowledge of the concepts, principles, and practices of management.
JD, MD, or PhD degree in an appropriate medical or biomedical field.
Demonstrated understanding of the FDA regulations, ICH CGP guidelines, and experience with multi-center clinical trials.
Knowledge of AAHRPP accreditation standards related to the protection of human subjects in research.
Knowledge of State laws, regulations, and policies pertaining to human subjects research.
Jontae McClure via email at email@example.com or by phone at 850-644-8660.
This is an A&P (Administrative and Professional) position.
Criminal Background Check
This position requires successful completion of a criminal history background check.
This position requires annual Financial Disclosure based on Florida Statutes 112.3144 and 112.3145. Additional information regarding Financial Disclosure requirements can be found on the Florida Commission of Ethics site at: http://www.ethics.state.fl.us/FinancialDisclosure/Index.aspx
How To Apply
If qualified and interested in a specific job opening as advertised, apply to Florida State University at https://jobs.fsu.edu. If you are a current FSU employee, apply via myFSU > Self Service.
Applicants are required to complete the online application with all applicable information. Applications must include all work history up to ten years, and education details even if attaching a resume.
Open until filled
This position is being advertised as open until filled.
Tobacco Free Campus
Effective January 1, 2014, tobacco use, including simulated tobacco use, is prohibited on property, interior and exterior, owned or managed by Florida State University. This policy applies to all Florida State University students, employees, consultants, contractors, visitors, and external individuals.
Equal Employment Opportunity
An Equal Opportunity/Access/Affirmative Action/Pro Disabled & Veteran Employer.
FSU's Equal Opportunity Statement can be viewed at: http://www.hr.fsu.edu/PDF/Publications/diversity/EEO_Statement.pdf