Lead Regulatory Research Coordinator, Gene Therapy Trials

Nationwide Children's Hospital Inc; United States; On-site; USD 90,000 - 140,000; Full time

Job summary

Nationwide Children’s Hospital is seeking an experienced clinical research professional to oversee orientation, day-to-day supervision, and ongoing development of team members involved in clinical trials. The role ensures trials are conducted safely, efficiently, and in strict adherence to protocol and regulatory requirements.

You will guide staff through study coordination activities, ensure data quality, support IRB processes, and manage study portfolios while onboarding new hires and

Qualifications

• Bachelor’s degree required; work experience may substitute for degree.
• 2+ years of experience managing clinical research projects.
• Certified Clinical Research Professional (SOCRA/ACRP) or eligible within six months of hire.
• In-depth knowledge of FDA and IRB regulations.
• Excellent verbal and written communication skills.

Responsibilities

• Coordinate all elements of research studies to meet enrollment targets and ensure data quality.
• Provide guidance and oversight to staff in study coordination and patient safety.
• Monitor and ensure start-up, enrollment, documentation, and protocol adherence.
• Support regulatory/IRB issues for the team post-study initiation.
• Onboard and train new hires and assist with performance management.

Skills

Leadership abilities

Verbal and written communication

Data quality oversight

Analytical skills

Attention to detail

Regulatory knowledge (FDA/IRB)

Study coordination

Problem solving

Team guidance

Education

Bachelor’s degree

Tools

Microsoft Office Suite

Job description

Nationwide Children’s Hospital is seeking an experienced clinical research professional to oversee orientation, day-to-day supervision, and ongoing development of team members involved in clinical trials. The role ensures trials are conducted safely, efficiently, and in strict adherence to protocol and regulatory requirements.

You will guide staff through study coordination activities, ensure data quality, support IRB processes, and manage study portfolios while onboarding new hires and