Senior Clinical Research Associate
Core
Senior Clinical Research Associate acting as the primary sponsor point of contact for investigative sites, leading site engagement, training, and monitoring to ensure protocol compliance and patient safety.
Role type
Senior Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical trial execution at investigative sites
Domain
Clinical Research / Pharmaceutical
Required skills
Site evaluation and training, Risk-based monitoring, Protocol compliance, Patient recruitment and retention strategies, Regulatory knowledge (ICH/GCP), Mentorship of junior CRAs, Data quality assurance, Investigator identification
Preferred skills
Tertiary qualification in health-related disciplines (Medical, Scientific, Pharmacy, Nursing), 2+ years of independent clinical research monitoring experience
Technologies
Site engagement tools, Risk assessment tools
Responsibilities
Conduct site evaluation, training, routine on-site and off-site monitoring, and site closure activities; Align and train site staff and principal investigators on trial goals; Mentor and train less experienced CRAs; Proactively assess risks and drive corrective actions; Identify and evaluate new potential investigators/sites; Ensure quality of data submission and audit readiness.
Seniority
Senior, hands-on IC with mentorship responsibilities