Site Director

About the role

Wake Research is a leading clinical research organization dedicated to advancing medical innovation through rigorous, high-quality clinical trials. The Clinical Research Site Director oversees all site operations to ensure the timely and compliant execution of assigned studies while maintaining the highest standards of quality and regulatory compliance. In this role, the Site Director advances that mission by leading day-to-day site operations and staff performance to consistently meet enrollment, quality, and compliance targets.

Responsibilities

• Lead all aspects of clinical trial site operations—from pre-study assessments and site initiation through subject recruitment, retention, and protocol compliance to study close-out
• Hire, train, and develop site staff; conduct performance reviews and establish KPIs to ensure consistent operational excellence
• Manage site enrollment and subject retention targets; implement strategies to reduce no-shows and meet protocol timelines
• Oversee regulatory compliance, FDA/ICH-GCP adherence, and sponsor/CRO audit readiness; prepare site for monitoring and inspection visits
• Serve as primary liaison between the site, sponsors, CROs, and corporate teams; manage budgets, revenue targets, and financial performance
• Schedule site operations and staff coverage to meet subject visit needs; coordinate with Central Service teams (Source, CTMS, Regulatory, Quality, Marketing)
• Ensure staff maintain current FDA and ICH-GCP training; monitor protocol adherence and source documentation quality
• Evaluate trial viability and site capacity; work with business development to assess new trial opportunities and staffing requirements

Qualifications

• Bachelor’s degree or equivalent and relevant formal academic experience
• Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), or equivalent certification, preferred
• Previous experience as a Clinical Research Site Manager or Site Director required
• 5+ years of clinical research experience preferred
• 3–5 years of people management experience strongly preferred
• Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP), and ISOs
• Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills
• Strong written and verbal communication skills; ability to consume, absorb, and analyze large amounts of information
• Ability to multi-task, work under time constraints, and work independently and cooperatively with interdisciplinary teams

Benefits

• 401(k) with matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance