Site Director

Overview

• Lead operational performance for a clinical research site specializing in internal medicine trials.
• Ensure compliance with ICH guidelines, GCP, FDA regulations, and company policies.
• Collaborate with department leaders to achieve study milestones and deliver quality data.
• Oversee site management, staff performance, and resource allocation for clinical trials.
• Develop and implement corrective action plans to address emerging risks.
• Provide training on protocols, SOPs, and clinical guidelines to ensure compliance.
• Manage payroll, absence tracking, and employee orientation for site staff.
• Collaborate with investigators to ensure patient safety and meet project goals.
• Participate in management meetings and contribute to strategic decision-making.

Key Responsibilities & Duties

• Drive site performance, enhance efficiencies, and ensure regulatory compliance.
• Coordinate with business development, patient recruitment, and finance teams to meet study objectives.
• Monitor dashboards and systems to oversee site and patient activities.
• Allocate resources and manage study team performance to meet deliverables.
• Conduct training sessions on protocols, CRF completion, and SOPs.
• Ensure adherence to GCP, FDA regulations, and company policies.
• Assess compliance and develop corrective action plans for site operations.
• Manage staff activities, including hiring, performance reviews, and career coaching.
• Collaborate with investigators to ensure patient safety and project success.

Job Requirements

• Bachelor’s degree in a relevant field with 7+ years of clinical research experience.
• Minimum 2 years of management experience in clinical research site operations.
• Proficiency in Microsoft applications, electronic health records, and web applications.
• Strong organizational, time management, and problem-solving skills.
• Effective written and verbal communication skills for diverse interactions.
• Ability to handle sensitive information confidentially and professionally.
• Experience managing KPIs, performance, hiring, and employee reviews.
• Bilingual proficiency in English and Spanish is a plus.
• Willingness to relocate for the position.