Site Director, Clinical Operations (CRA)

Site Director, Clinical Operations (CRA)

The Site Director, Clinical Operations is responsible for comprehensive clinical site management, including site identification, feasibility, pre-study evaluations, study start-up, site initiation, patient recruitment, monitoring, close-out activities, inspection readiness, and local regulatory and IRB/EC submissions for assigned clinical studies. This role ensures all activities align with study protocols, SOPs, ICH-GCP guidelines, and applicable regulatory requirements. Using available systems and tools, the Site Director will oversee site activities both onsite and remotely, ensuring patient rights, safety, and data integrity. The position is accountable for patient enrollment and timely delivery of high-quality patient data across designated sites and/or assigned regions.

Key Responsibilities:

• Lead start-up, monitoring, and execution of Phase I-IV studies at assigned sites.
• Conduct site management and monitoring per ICH-GCP, SOPs, local regulations, study protocols, and applicable guidelines.
• Act as the primary point of contact for sites throughout study phases.
• Ensure data entry timelines are met and monitor data accuracy through source data verification.
• Develop and maintain strong site relationships to ensure consistent engagement.
• Address protocol conduct issues, recruitment, deviations, inspection readiness, and performance concerns.
• Identify, escalate, and resolve site performance or quality issues promptly.
• Perform feasibility and site identification for new studies.
• Manage start-up and maintenance activities, including preparation and collection of essential documents for regulatory and IRB/EC submissions (initial and amendments).
• Facilitate communication with site staff for start-up and submissions.
• Support budget and contract negotiations for clinical trial agreements, collaborating with clinical program management and finance.
• Develop site-specific recruitment, retention, and follow-up plans.
• Support site audits and inspections as needed.
• Perform remote data reviews and resolve queries for assigned sites.
• Share best practices and participate in process improvement initiatives within the clinical operations team.
• Provide coaching and mentorship to colleagues.
• Contribute to reviews of internal systems and procedures.
• Participate in other study management and staff training activities as required.

Education & Experience Requirements:

• Bachelor’s degree in a Life Science discipline required; Bachelor’s in Nursing or RN preferred.
• Minimum 3 years of direct site monitoring experience.
• In-depth knowledge of clinical site monitoring and the overall drug development process.
• Comprehensive understanding of FDA, ICH, GCP guidelines, and relevant local regulations.
• Strong critical thinking skills, with the ability to interpret complex patient histories, medical terminology, and treatment landscapes.
• Proven ability to interpret study metrics and proactively identify and address study risks.
• Detail-oriented, organized, and committed to quality.
• Results-driven with experience managing multiple high-priority assignments to successful, timely completion.
• Excellent interpersonal skills and ability to work collaboratively in team environments.
• Flexibility to adapt to dynamic environments.
• Commitment to process improvement and adding value through efficient workflows.
• Exceptional written and verbal communication skills.
• Experience with CTMS and eTMF systems preferred.
• Willingness and ability to travel up to 50-65%.