Research Compliance Analyst/Specialist

2 months ago


Cincinnati, United States University of Cincinnati Full time

Job Overview

The HRPP department is seeking a Research Compliance Analyst to join their team. The successful candidate may be appointed to a Research Compliance Specialist based on qualifications, experience, and skills. This position will need someone who has experience with human subjects, Institutional Review Board (IRB), and knowledge of regulations and guidelines pertaining to human research (ICH, GCP, and HIPAA). They will need to possess the ability to work independently, prioritize, interpret both internal and external research regulatory documentation, and have computer skills and knowledge of word processing, spreadsheets, databases, and graphics.

Essential Functions

Serve as liaison for designated research protocols/studies; perform initial/ongoing research protocol reviews and provide advice to the Board/Committee; perform protocol audits as required; attend Board/Committee meetings to review and discuss studies to ensure compliance with federal state, local regulations, and University policies and procedures; act as a resource for Board/Committee members regarding regulations during research protocol review. Resolve all issues involving research protocols. Interpret, analyze and apply federal, state, and local regulations, along with University rules and regulations, to ensure ethical research practices are followed; report suspected or known instances of noncompliance with University or federal regulations. Coordinate information to meet protocol reporting requirements; resolve routine issues involving protocols including direct communication with investigators and research staff; interact with investigators, faculty, students and administration of all levels. Assist in the development and maintenance of daily operational policy and procedures. Perform related duties based on departmental need. This job description can be changed at any time.

Required Education

Bachelor’s Degree in a related field. Five (5) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Required Experience

One (1) year of experience in a compliance, basic science or clinical research environment.

Physical Requirements/Work Environment

Office environment/no specific unusual physical or environmental demands.

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