Clinical Research Site Director

Overview

• Lead operational performance and management for a clinical research site, ensuring adherence to regulatory guidelines and company policies.
• Collaborate with department leaders to meet study milestones, enhance efficiencies, and deliver quality data to sponsors.
• Oversee site and patient activities, ensuring timely execution of operational aspects and proper staff coverage.
• Manage resourcing allocations and study team performance to ensure study deliverables are on track.
• Provide training on protocols, SOPs, clinical plans, and guidelines to ensure compliance and quality.
• Ensure adherence to GCP, FDA regulations, and company policies, identifying risks and implementing corrective actions.
• Oversee people management activities, including hiring, performance appraisals, and career coaching.
• Collaborate with investigators to ensure patient safety and achieve client goals and timelines.
• Employ strategic thinking to propose and implement risk mitigations for site operations.

Key Responsibilities & Duties

• Drive site performance, focusing on patient safety, protocol compliance, and operational efficiency.
• Coordinate with various departments to meet study milestones and deliver quality data.
• Monitor site activities and ensure timely execution of operational aspects.
• Manage staff assignments and performance, identifying risks to study deliverables.
• Provide training on study-specific processes, compliance, and timelines.
• Ensure compliance with regulatory guidelines and company policies, addressing emerging risks.
• Oversee site staff management, including hiring, training, and performance evaluations.
• Collaborate with investigators to ensure patient safety and study success.
• Participate in management meetings and contribute to strategic planning.

Job Requirements

• Bachelor’s degree in Science or equivalent education and experience.
• Minimum 5 years of clinical research experience, with 2 years in site management.
• Proficiency in Microsoft applications, electronic health records, and web applications.
• Strong organizational, time management, and project management skills.
• Excellent written, verbal, and interpersonal communication abilities.
• Ability to handle sensitive information confidentially and professionally.
• Experience managing teams and resolving operational challenges.
• Knowledge of GCP, FDA regulations, and clinical research protocols.
• Bilingual proficiency (English/Spanish) is a plus.