Job Title: Clinical Research Site Director

Work Location: Albemarle County, Virginia

Summary:

The Clinical Research Site Director is responsible for leading and managing all aspects of a clinical research site, ensuring operational excellence, regulatory compliance, and high-quality data delivery. This role oversees site staff, coordinates with various departments, and ensures the successful execution of clinical trials in accordance with industry standards and guidelines.

Responsibilities:

• Lead and manage overall site operations, focusing on performance, efficiency, patient safety, and compliance with protocols and regulatory standards.
• Coordinate with leaders in business development, patient recruitment, finance, contracts, and quality to achieve study milestones, budget targets, and deliver quality data.
• Monitor site and patient activities using performance dashboards and clinical trial systems to ensure timely and accurate execution of operational tasks.
• Oversee resource allocation, site assignments, and team performance, identifying and escalating risks to study timelines, quality, or budget as needed.
• Support and deliver initial and ongoing training for staff on study protocols, CRF completion, SOPs, and clinical guidelines.
• Ensure adherence to SOPs, GCP, FDA regulations, and internal policies, routinely assessing compliance and identifying emerging risks.
• Develop and implement corrective action plans at both site and study levels to address operational or compliance issues.
• Manage site staff, including recruitment, performance appraisals, training, and resolution of operational issues, while supporting successful site operations.

Qualifications:

• Bachelor’s degree and 5+ years of clinical research experience, or equivalent combination of education and experience.
• Minimum 2 years of management experience required.
• Experience in clinical research site management required.
• Bi-lingual proficiency in English and Spanish is a plus.
• Proficiency with Microsoft applications, email, electronic health records, web applications, and ability to type at least 40 wpm.
• Strong organizational, time management, problem-solving, and project management skills.
• Excellent written and verbal communication, interpersonal, and listening skills.
• Ability to work independently and collaboratively, handle multiple tasks, and adapt to changing priorities.
• Professionalism, integrity, dependability, and a strong work ethic.
• Ability to handle sensitive information confidentially and in compliance with HIPAA guidelines.

Published Category: Clinical Operations & Development