Senior Research Compliance Specialist

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Posted: Unknown

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Summary:

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Posted: 23-Apr-25

Type: Full-time

Categories:

Financial
Staff/Administrative

Internal Number: R125776

The Senior Research Compliance Specialist position serves as a subject matter expert in human subject and clinical research and can critically evaluate research compliance matters to ensure the research communitys compliance with federal, state, and local laws and regulations as well as institutional policies. The successful candidate will understand complex and dynamic federal regulations, requirements and policies related to the responsible conduct of research and must be able to exercise authority through influencing others and rely on their strong interpersonal, leadership, management, and communication skills to effectively engage and interact with all stakeholders. The position will help the researcher community to navigate regulatory processes and requirements.

The Senior Research Compliance Specialist position supports efforts to strengthen human subject, animal and laboratory research compliance by working through key components of program assessments and outlining short- and long-term plans to address concerns and gaps. This will include working with key stakeholders to collaboratively develop, implement and communicate new standard operating processes and procedures; identifying, implementing and tracking compliance controls across units and teams; generating and collecting reportable metrics from multiple stakeholders to be included in annual assessments.

The Senior Research Compliance Specialist position will engage in activities to proactively identify potential situations of non-compliance and support research related internal independent reviews and investigations to ensure compliance with university policies and state and federal laws and regulations. The position will help ensure research-related complaints are consistently assessed and resulting investigations are planned and conducted in a timely manner. The position may help facilitate post-compliance review/investigation corrective actions.

The position will work with institutional partners with identifying opportunities to develop training and educational resources within key areas impacting compliance within the human subject, animal and laboratory research space.

The Senior Research Compliance Specialist will provide cross research compliance support, as necessary, to the Office of Research Compliance and Office of Secure Research.

The successful candidate for this position will have a high level of comfort in challenging and dynamic situations. The ideal candidate will have superior communication, organizational, interpersonal and problem-solving skills, be detail-oriented; the ability to efficiently and accurately analyze and interpret complex data; and flexibility to work with a wide variety of stakeholders on conveying difficult, complex and sensitive information, and work successfully in both a team-integrated and independent fashion.

Required Qualifications:

• Bachelor's degree in biological sciences, health sciences or medical field or equivalent experience.

• Minimum of 6 years of relevant of human subject research/clinical trials research experience within a large organization.

• Working experience in higher education, compliance, or research.

• Ability to provide a high level of professional interaction with all levels of diverse stakeholders throughout the university.

• Superior organizational and interpersonal skills; experience facilitating effective teamwork; detail-oriented; ability to efficiently and accurately analyze and report complex information.

• Experience writing clear and well-documented processes and reports.

• Experience with development of educational and training resources.

• Candidate must be proficient in all Microsoft Office software.

Desired Qualifications:

• Advanced degree such as Masters degree, Doctoral degree or JD.

• 8-12 years of relevant experience preferred.

• Considerable experience and knowledge of human subject research including compliance requirements with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations.

• Clinical research certification from an accredited certifying agency (SOCRA or ACRP)

• Familiar with clinical research audits and quality assurance

• Considerable experience and knowledge of grants, research administration, higher education, and/or compliance.

• Knowledge of state and federal laws and regulations governing human subject and animal research

It is strongly desired that applicants submit both a resume and a cover letter.

The pay range for this job profile is $74,900 $98,500. The offer for this position will fall within this range based on multiple factors including internal equity, units available budget, and the candidates qualifications.

Join the Office of Research Integrity and Investigations in the Enterprise for Research, Innovation and Knowledge (ERIK) at The Ohio State University and become a part of a dynamic, forward-thinking team dedicated to pushing the boundaries of discovery and innovation. ERIK positions Ohio State to expand curiosity-driven research and creative expression, further develop our research community of faculty, staff, and students, and grow the innovation ecosystem to address big challenges and improve communities locally and globally. We are seeking passionate individuals who are committed to making a meaningful impact through collaboration, innovation, and excellence. To learn more about our mission and work, please visit https://erik.osu.edu/ .

Function: Research Administration

Subfunction: Research Compliance

Career Level: S4

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About The Ohio State University
The Ohio State University is a dynamic community of diverse resources, where opportunity thrives and where individuals transform themselves and the world. Founded in 1870, Ohio State is a world-class public research university and the leading comprehensive teaching and research institution in the state of Ohio. With more than 63,000 students (including 57,000 in Columbus), the Wexner Medical Center, 14 colleges, 80 centers and 175 majors, the university offers its students tremendous breadth and depth of opportunity in the liberal arts, the sciences and the professions.
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