Research Compliance Senior Analyst - College of Medicine Office of Research

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Under the direction of the Senior Director, Research Compliance and Operations, and in partnership with the Senior Director, Research Strategy and Operations, COM DEA license holder(s), and Associate Dean for Research Operations Compliance, the Research Compliance Senior Analyst serves as the subject matter expert (SME) and program lead for the College of Medicine Controlled Substances Program (COM CSP). This position designs, implements, and evaluates research compliance frameworks to ensure the COM CSP meets U.S. Department of Justice Drug Enforcement Administration (DEA), State of Ohio Board of Pharmacy (BOP), University and COM requirements. The Research Compliance Senior Analyst leads program development and enterprise-wide projects including the rollout and optimization of technology platforms such as Vestigo Pre-Clinical, and Environmental Health and Safety (EHS) Assist, development of standard works, process documents, web page development, researcher guidance, and development of high-impact metrics and reporting. The Research Compliance Senior Analyst leads DEA and BOP research laboratory inspections and develops internal inspection and monitoring strategies to proactively identify and mitigate regulatory compliance risks. Provides strategic consultation to investigators and research teams and collaborates with institutional partners including Office of Legal Affairs, EHS, Office of Research Compliance, Investigational Drug Service, The James Inpatient Pharmacy, internal and external suppliers. Serves as the primary regulatory liaison and compliance advisor for COM CSP operations. Advises the University on policy and training programs; ensures continuous improvement in research compliance and program scalability. May mentor and train junior COMOR-C team members.

Minimum Education Required
Bachelor's Degree or equivalent experience
 

Required Qualifications

Bachelor’s degree or equivalent experience. 4 years’ experience (4-8 preferred) in a regulatory compliance, auditing, or regulatory affairs capacity in a research, government, or healthcare setting. Demonstrated expertise in controlled substances regulations, narcotics/pharmaceutical management, and research compliance. Proven experience leading cross-functional initiatives, developing protocols and SOPs, and implementing compliance systems.

Preferred Qualifications

Advanced degree in regulatory affairs, compliance, public health, pharmacy, or related field. Experience with DEA/BOP inspections, federal and state licensing processes, and vendor management. Expertise in laboratory inspection programs and internal auditing methods. Knowledge of federal and sponsor research compliance frameworks. Experience developing and leading compliance programs. Active certification(s) preferred: CPhT, RPhT, CPIA, or equivalent.

Function: Research Administration

Sub-Function: Research Compliance

Career Level: S3

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Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.

The university is an equal opportunity employer, including veterans and disability.