Senior Regulatory Compliance Officer – Clinical Trials Office

Role Overview

• Provides regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the OSUCCC Clinical Trials Office.
• Assists the Regulatory Manager with the oversight and monitoring of the regulatory research compliance function across all disease teams managed by the clinical trials office (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 provides technical support to junior members on the team.
• Provides coverage/back up as needed for Regulatory manager and/or team members.
• Manages complex submissions and assists 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 onboarding and educational training programs, tools and materials for CTO staff, and investigators.
• Provides regulatory guidance, direction and support to all members of the research team.
• Stays current on legislation, rules, regulations, procedures, and development; educates physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients.
• Works with CTO Managers and coordinators as needed to ensure understanding of study protocols.

Requirements

• Bachelor’s degree in relevant field required or equivalent combination of education and experience; Master’s degree in a relevant field desired;
• 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;
• 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.

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.