Clinical Research Site Director

Overview

• Lead and oversee operations at a clinical research site, ensuring compliance with industry standards and regulations.
• Drive site performance, enhance operational efficiencies, and ensure patient safety and protocol adherence.
• Collaborate with department leaders to meet study milestones, budgets, and deliver high-quality data.
• Manage site staff, including hiring, training, performance appraisals, and career development.
• Ensure adherence to standard operating procedures, GCP, FDA regulations, and company policies.
• Monitor site activities and implement corrective actions to mitigate risks and ensure compliance.
• Provide strategic oversight and problem-solving to address operational challenges effectively.
• Participate in management meetings and contribute to organizational strategies and goals.

Key Responsibilities & Duties

• Oversee site management and leadership to ensure operational excellence and regulatory compliance.
• Coordinate with department leaders to achieve study milestones and deliver quality data.
• Monitor performance dashboards and clinical trial systems for timely execution of operational aspects.
• Manage resource allocations, site assignments, and study team performance to meet objectives.
• Provide training on protocols, SOPs, and clinical plans to ensure team readiness.
• Develop and execute corrective action plans to address compliance and operational risks.
• Supervise site staff, including payroll, absence tracking, and orientation processes.
• Collaborate with investigators to ensure patient safety and achieve client goals.

Job Requirements

• Bachelor’s degree in Science or equivalent combination of education and experience.
• Minimum of 5 years of clinical research experience; 8 years preferred.
• At least 2 years of experience in clinical research site management.
• Proficiency in Microsoft applications, electronic health records, and web applications.
• Strong organizational, time management, and project management skills.
• Excellent written and verbal communication skills; bilingual proficiency in English and Spanish is a plus.
• Ability to handle sensitive information confidentially and professionally.
• Experience managing medium to large clinical research sites is essential.