Northern California HERC

Under the direction of the Senior Director, Research Strategy and Operations, the Controlled Substances Program Officer (CSPO) serves as the subject matter expert (SME) and program co-lead for the College of Medicine Office of Research Controlled Substances Program (COM CSP). The CSPO implements and evaluates regulatory 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 CSP requirements. The CSPO implements and oversees COM CSP development and enterprise-wide projects including the rollout and optimization of technology platforms such as CampusOptics, internal standard works, process documents, web page maintenance, researcher guidance, and high-impact metrics and reporting. The CSPO co-leads DEA and BOP research laboratory inspections and develops internal inspection and monitoring strategies to proactively identify and mitigate regulatory risks. Provides strategic consultation to researchers and collaborates with university partners including the Office of Legal Affairs, EHS, Office of Research Compliance, Investigational Drug Service, The James Inpatient Pharmacy, and internal and external suppliers. Serves as a primary regulatory liaison and advisor to the Senior Director, Research Strategy and Operations and the COM Responsible Person, in collaboration with COMOR-C. Advises on policy and training programs; ensures continuous improvement in COM CSP scalability. May mentor and train junior team members.

Minimum Education Required

Bachelors degree or equivalent experience.

Minimum Required Qualifications

Bachelors degree or equivalent experience. 4 years experience (4-8 preferred) in a regulatory affairs capacity within 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 processes and implementing regulatory systems.

Additional Education Desired

Advanced degree in pharmacy, or related field.

Required Qualifications

Experience with DEA/BOP inspections, federal and state licensing processes, and vendor management. Expertise in research laboratory inspection programs and internal inspection methods. Knowledge of federal and sponsor regulatory frameworks. Experience developing and overseeing operational 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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