Senior Clinical Research Associate
Core
Senior Clinical Research Associate leading site engagement, monitoring, and risk management for clinical trials to ensure data integrity, compliance, and patient safety.
Role type
Senior Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical trial execution and data integrity for investigational drug/device trials
Domain
Biopharmaceuticals / Clinical Research
Required skills
Site evaluation and selection, On-site and off-site monitoring, Risk-based monitoring, Protocol compliance, Patient recruitment and retention strategies, Regulatory knowledge (ICH/GCP), Mentorship of junior CRAs, Data quality assurance, Investigator relationship management
Preferred skills
Tertiary qualification in health-related disciplines (Medical, Scientific, Pharmacy, Nursing), 2+ years of independent clinical research monitoring experience, Therapeutic area expertise
Technologies
Clinical trial management tools, Site engagement tools, Risk assessment platforms
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 and protocols; Proactively assess risks and resolve site risk signals; Identify and recommend new potential investigators and sites; Ensure audit and regulatory inspection readiness; Mentor less experienced CRAs.
Seniority
Senior, hands-on IC with mentorship responsibilities