Senior Regulatory Compliance Officer - CCC | Clinical Trials Office

The Ohio State University

1d • Remote

About The Position

The Senior Regulatory Compliance Officer provides regulatory expertise to ensure research protocols comply with university, state, and federal regulations across research groups managed by the OSUCCC Clinical Trials Office (CTO). This role involves oversight, monitoring, and serving as a subject matter expert for regulatory compliance officers, managing complex submissions, and contributing to the development of Standard Operating Procedures (SOPs) and training programs. The position also involves providing regulatory guidance and staying current with all relevant legislation and regulations impacting clinical research.

Requirements

• Bachelor’s degree in relevant field required or equivalent combination of education and experience.
• Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) required.
• 3 – 5 yrs. of experience in a clinical research or administrative capacity working on clinical research projects required.
• Considerable knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required.

Nice To Haves

• Master’s degree in a relevant field desired.
• Experience and knowledge of federal & industry research sponsor requirements preferred.
• Experience in a regulatory affairs capacity in a medical research setting desired.
• Experience in protocol development desired.

Responsibilities

• Assists the Regulatory Manager with the oversight and monitoring of the regulatory research compliance function across all disease teams managed by the CTO.
• Serves as the subject matter expert for all regulatory compliance officers within the departments.
• Reviews regulatory documents prior to submission to sponsors, IRB, FDA to ensure compliance.
• Answers questions and provide technical support to junior members on the team.
• Provides coverage/back up as needed for Regulatory manager and/or team members.
• Manages complex submission and assisting junior team members with the process.
• Participates in the development of SOPs and Processes for the regulatory team to stay current with the changing regulatory requirements and training.
• Participates in the creation and delivery of on boarding and educational training programs, tools and materials for CTO staff, and investigators.
• Provides regulatory guidance, direction and support to all members of research team.
• Stays current on legislation, rules, regulations, procedures, and development; educate physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients.
• Work with CTO Managers and coordinators as needed to ensure understanding of study protocols.

Benefits

• Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost.
• Paid time off, including sick and vacation time and 11 holidays.
• State retirement plan or an alternative retirement plan, both with generous employer contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior