Senior Regulatory Compliance Officer - Clinical Trials Office at Ohio State University - Columbus in Columbus Campus

Job description

• The Senior Regulatory Compliance Officer (RCO) for Investigator-Initiated Trials 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 and will be responsible for regulatory affairs for investigator-initiated oncology clinical trials during study start-up.

Responsibilities

• 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 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;
• Reviews, evaluates, and compiles files and reports for submissions for initial investigational new drug applications (INDs), investigational device exemptions (IDEs), protocol submissions, and annual reports;
• Collaborates with investigators during study development to facilitate and confirm that appropriate regulatory safeguards have been included;
• Conducts detailed reviews of assigned protocols and informed consent forms prior to FDA/IRB review;
• Communicates with all research projects’ sponsors (academic, federal, industry) to ensure compliance;
• Interfaces with various internal and external entities to coordinate and effectively compile all appropriate data relevant to the conduct of trials;
• Develops FDA submission packets for protocols, submission of standard forms, and drafting of informed consent forms;
• Reviews technical and clinical protocol documentation and recommends changes in clinical protocol for regulatory compliance;
• Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registrations.

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.

Skills

Required

• Regulatory compliance
• Clinical research regulations
• Knowledge of FDA regulations
• Knowledge of IRB processes
• Protocol review
• Informed consent drafting
• Technical writing
• Attention to detail
• Communication skills
• Organizational skills

Preferred

• Protocol development experience