Regulatory Affairs Specialist

Cleveland VA Medical Research & Education Foundation

The Cleveland VA Medical Research and Education Foundation is home to a variety of investigational and educational professionals. Our program is comprised of research in biomedical, health services and rehabilitation, as well as clinical and cooperative studies.

The Cleveland VA is home to two VA-funded Rehabilitation Research and Development centers: The Advanced Platform Technology (APT) Center and the Functional Electrical Stimulation (FES) Center. The Medical Center has full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The Cleveland VA academic affiliates include Case Western Reserve University and Cleveland Clinic Foundation.

Overview
The Regulatory Affairs Specialist is responsible for managing regulatory submissions and compliance activities for clinical and research studies. This role independently supports Principal Investigators (PIs) by preparing IRB submissions, maintaining regulatory documentation, and ensuring adherence to VA, federal, sponsor, and institutional requirements. The position requires solid regulatory experience and the ability to manage tasks with minimal supervision.

Key Responsibilities

• Prepare and submit regulatory documents, including initial applications, amendments, continuing reviews, protocol deviations, and adverse event reports
• Manage regulatory oversight for assigned studies from start‑up through closeout
• Maintain accurate regulatory files and essential documents in accordance with sponsor and institutional guidelines
• Ensure all study documentation (CVs, licenses, training records, consent forms) is current and compliant
• Monitor study compliance and assist with audit preparation and sponsor monitoring visits
• Interpret and apply changes to regulations, policies, and IRB requirements
• Coordinate study start‑up processes, including scheduling site initiation visits and reviewing site qualifications
• Serve as liaison between PIs, sponsors, CROs, and IRBs to ensure clear and timely communication
• Support investigators in using IRB and institutional systems for regulatory submissions
• Train junior team members and provide guidance to research personnel on regulatory best practices

Qualifications

Required:

• Bachelor’s degree in a science, health, regulatory, or related discipline
• 2–5 years of experience in regulatory affairs, clinical research, IRB administration, or research compliance
• Strong working knowledge of human subjects research regulations and Good Clinical Practice
• Ability to work independently, manage multiple deadlines, and problem‑solve effectively
• Excellent written and verbal communication skills

Preferred:

• Experience with VA research processes and systems (VAIRRS, VA CIRB)
• Professional certification (CCRP, CIP, or related)
• Experience supporting multi‑site NIH, VA, or industry‑sponsored trials

Pay: $55,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $55,000 - $70,000