Post-Approval Monitoring & Regulatory Support Specialist
The Ohio State University

Job Info

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Job Title:Post-Approval Monitoring & Regulatory Support SpecialistDepartment:ERIK | Office of Responsible Research Practices

The Post-Approval Monitoring and Regulatory Support Specialist reports to the Sr. Consultant, Post-Approval Monitoring and Regulatory Support and is responsible for activities that support institutional accreditation of the Human Research Protection Program (HRPP), efficient and compliant Institutional Review Board (IRB) and Office of Responsible Research Practices (ORRP) operations, and provides customer service to faculty, staff, and students conducting human subjects research. Facilitates the HRPP post-approval monitoring program, conducts educational post-approval monitoring visits as advised by the post approval monitoring plan; facilitates QI assessments of the IRBs and ORRP staff; works in collaboration with ORRP's quality improvement (QI) team to manage and support on-going activities and requirements related to the university's HRPP accreditation, including policy/guidance development and maintenance, and other program-related activities. Participates in activities to achieve the quality, efficiency, and compliance goals of the ORRP QI Team. Supports IRB investigations and reports findings of noncompliance with federal regulations and HRPP policies; works closely with ORRP staff related to noncompliance review and resolution; facilitates IRB operations as needed through receiving and screening non-exempt submissions.

MINIMUM REQUIRED QUALIFICATIONS
Bachelor's degree or equivalent combination of education and experience; minimum of 4 years of relevant work experience; knowledge of and experience in applying complex regulations governing human subjects research; knowledge of and experience in research administration/post-approval monitoring/auditing and research methodologies; Certified IRB Professional (CIP) credential preferred or will obtain within 2 years of hiring; strong problem solving and customer service experience; strong organizational, writing, and analytical skills; strong interpersonal communication skills with the ability to work well with multiple constituencies of varying educational backgrounds; proficient in the use of Microsoft Office applications; successful completion of a criminal background check. A drug screening or physical may be required during the post offer process.

Qualifications Desired

4-8 years of human subjects regulatory experience or relevant work experience; knowledge of and experience in research administration/post-approval monitoring/auditing and research methodologies. Clinical research or social sciences research experience preferred. Master's Degree in a health or social sciences related discipline

Additional Information:

Function : Research Administration

Subfunction : Research Quality Improvement

Career Level : S3

Office of Responsible Research Practices (ORRP) provides a collaborative, autonomous work environment with a strong emphasis on work/life balance. Employees are provided several flexible work schedule and location options, including an option for remote work aligned with U.S. Eastern Time Zone. All staff may be expected to attend certain periodic in-person work events during the year, regardless of work schedule and location. All employees are provided University-configured equipment and supportive technology tools. Employees will be required to provide reliable internet access and home office furnishings.

The Ohio State University offers competitive and comprehensive benefit options. Explore https://hr.osu.edu/careers/ for more information.

We strongly encourage that applicants submit both a resume and a cover letter.

Location:Mount Hall (0311)Position Type:RegularScheduled Hours:40Shift:First ShiftFinal candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.

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