Director, Human Research Protection Program

Director, Human Research Protection Program

EEO Statement  | Wright State University is an equal opportunity employer.
Faculty Rank or Job Title  | Director, Human Research Protection Program
Job Category:  | Administrative (exempt/non-exempt)
Department  | Research & Sponsored Programs
EEO number:  | 25P185
Position FTE  | 100%
Minimum Annual or Hourly Rate  | $70,000
Salary Band:  | UC S06

Job Summary/Basic Function:  | The purpose of the position is to direct and manage the operations of the Institutional Review Board (IRB) and the University’s human subjects protection program that also provides services to external affiliated research institutions and researchers. The role is essential to ensure federal, state, and local regulatory compliance for all research activities involving human subjects reviewed and conducted under the current WSU human subjects protection program.

Minimum Qualifications  | - Bachelor’s degree and a minimum of 7 years related experience
- 3 years of progressively responsible IRB administration work experience at a University or hospital system.
- Demonstrated expert-level working knowledge of external regulations, laws, statutes and policies regarding the protection of human subjects, including but not limited to, the Common Rule, HIPAA and FDA regulations.
- Must be able to independently conduct reviews and audits of IRB protocols that require post-approval monitoring.
- Must possess excellent written and oral communication skills.
- Must be able to write clear and concise policies, procedures and guidelines related to human subjects’ research and demonstrate the ability to implement and clearly articulate those policies and their underlying principles to a diverse group of internal and external stakeholders.
- Must be able to maintain confidentiality in office operational transactions.
- Demonstrated ability to make presentations to large and small groups.
- Must be able to work with and engage stakeholders independently and use sound judgment when referring issues to higher organizational levels for consideration.
- Excellent problem-solving skills and demonstrated ability to resolve conflicts.

Preferred Qualifications  | - Master’s degree
- 5 years of progressively responsible IRB administration work experience at a University of hospital system.
- Knowledge of electronic software solution for submission, review and approval of IRB protocols; e.g., Cayuse.

Essential Functions and percent of time:  | 40%: Provide daily leadership, support and guidance to the IRB staff (including RSP Compliance Coordinator in charge of IACUC and IBC protocols who provides 20% IRB support), and oversight of the work of the undergraduate student assistant assigned to the IRB. Manage the review and approval process for IRB submissions via the Cayuse Human Ethics module. This includes reviewing applications for completeness and compliance, making exemption determinations, assigning IRB member reviewers, and communicating required revisions and other concerns in written and oral communication to investigators. Responsible for coordinating efforts of the IRB Office staff to ensure thorough and timely reviews of all IRB submissions. Must also manage full board meeting process, which includes scheduling meetings and generating agendas and minutes using Cayuse.

20%: Serve as an expert campus resource for interpreting and applying federal research regulations, policies and procedures related to research protections and compliance. Develop and implement training courses for individual investigators and members of the IRB that include both in-person sessions and online resources for Web accessibility.

Essential Functions and percent of time (cont'd):  | 15%: Manage the institutional review and approval process for WSU’s reliance on external IRBs. Directly engages with external parties, including the Air Force Research Laboratory, Premier Health and other institutions of higher education, to review and process External Reliance Agreements submitted in Cayuse. These duties require that the individual exhibit independent thinking and decision making. The External Reliance Agreement process requires that the individual negotiate agreements with other organizations and educate WSU investigators on the institutional requirements for these arrangements.

15%: Develop, revise, implement and monitor WSU IRB policies and procedures to ensure compliance with federal regulations, state statutes, and WSU systemwide policies. This includes independent monitoring and updating submission forms and data fields in Cayuse, as needed.

10%: Maintain the official roster of IRB members, assist in the recruitment of new members, conduct and coordinate initial and continuing education of IRB members, maintain WSU’s Federal wide Assurance with the U.S. Department of Health and Human Services, coordinate non-compliance investigations and coordinate and oversee audits of the IRB; e.g., FDA, etc.

Non-Essential Functions and percent of time:  |
Working Conditions  | Standard office working conditions.

To preserve the safety and security of the campus community and to maintain the integrity of university operations, it is the policy of Wright State University before making an employment offer conduct various background checks, such as a criminal record, credit history when job related and/or education verifications. Additionally, an administrative review shall be conducted whenever the university learns that an employee is charged with or convicted of a crime (except for minor vehicle violations). Frequently asked questions related to background checks may be found on the Human resources website at http://www.wright.edu/human-resources.

Effective July 1, 2017, per Policy 7230 Wright State University is tobacco-free. Tobacco use, including the sale, advertising sampling and distribution of tobacco products and tobacco related items is prohibited in all university facilities, on all university owned or leased grounds, university owned or operated residence halls and apartments, and at all university sponsored events regardless of location. Tobacco use is also prohibited in all university vehicles or on any equipment owned, leased or operated by Wright State University. This policy applies to anyone on campus including students, faculty, staff, visitors, consultants, vendors, patients, volunteers, and contractor employees.

Special Instructions to Applicants  |
Posting Date  | 05/19/2025
First Consideration Date:  | 05/30/2025
Closing Date  |
Open Until Filled  | Yes

Supplemental Questions

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Required Documents