Clinical Research Associate II
Core
Partner with investigators and site staff to ensure appropriate conduct of clinical trials, driving data integrity, compliance, and study performance.
Role type
Senior Clinical Research Associate (II)
Builds
Clinical trial execution and site monitoring
Domain
Biopharmaceuticals / Clinical Research
Required skills
Site evaluation and monitoring, Protocol compliance, Risk-based monitoring, Patient recruitment and retention, Regulatory knowledge (ICH/GCP), Data quality assurance, Investigator management, Therapeutic area knowledge
Preferred skills
Tertiary qualification in health-related disciplines, Knowledge of specific therapeutic area indications, Mentorship of less experienced CRAs
Technologies
CRM tools
Responsibilities
Conduct site evaluation, training, routine, and closure monitoring; Align and train site staff and principal investigators on trial goals; Ensure audit and regulatory inspection readiness; Manage investigator payments; Identify and evaluate potential investigators/sites; Monitor study performance and patient safety issues; Ensure timely data submission and safety event reporting.
Seniority
Senior, hands-on IC