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Job Title: Senior Regulatory Compliance Officer - Clinical Trials Office
Department: CCC | Clinical Trials Office
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.
Job 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.
Additional Information:
This position is primarily remote. New employees are required to attend in-person training sessions and orientation during onboarding. Following completion of onboarding, employees will be expected to attend occasional in-person activities such as in-person meetings, audits, monitoring visits, site initiation visits, etc.
Location: Optometry Clinic (1041)
Position Type: Regular
Scheduled Hours: 40
Shift: First Shift
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions.
The university is an equal opportunity employer, including veterans and disability.
Organization
About The Ohio State University
The Ohio State University, one of the biggest and most comprehensive universities in the country, creates experiences that bring together expertise, ideas and resources to improve communities locally and globally.
Ohio State is regularly honored as one of the nation's top 20 public universities. With campuses and research centers throughout the state, the institution's unrivaled depth and breadth advance innovation, health care and research within Ohio's communities. For more than 150 years, Ohio State has inspired the next generation of leaders, discovering groundbreaking medical breakthroughs and finding solutions to the problems the world is facing now.
Ohio State also has a top-rated academic medical center and a premier cancer hospital and research center.
Ohio State offers more than 200 majors and programs - plus 500 specializations - for undergraduates, in addition to more than 230 master's, doctoral and professional degree programs and an estimated 12,000 course offerings.
Join Ohio State's Community
At The Ohio State University, we connect people, ideas and resources to put knowledge into practice and create meaningful impact in people's lives. Buckeyes lead with purpose. We advance excellence and inspire people to join in and take action. Together, we'll create meaningful impact at a scale few others can match.
Explore our Extensive Benefits
Ohio State provides access to opportunities and resources for all employees. Starting your first day, Ohio State offers you a comprehensive benefits package.
- WORK-LIFE: Flexible and remote work arrangements where applicable, child care program, and access to educational, athletic and cultural events.
- RETIREMENT: State pension and alternative options with competitive employer contributions, as well as optional supplemental plans.
- HEALTH: Medical, dental, vision and prescription coverage, life insurance, flexible spending accounts and wellness programming.
- TIME OFF: Paid vacation and sick time, parental and medical leave plus 11 paid holidays. Short and long-term disability options also available.
- FINANCIAL: Tuition assistance for employees and their dependents, adoption assistance, and discounts with preferred vendors and university partners.
- WELLNESS: Lifestyle spending account, employee assistance program, health reimbursement account, and employee wellness program.
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