Clinical Research Associate II
Core
Partner with study teams, investigators, and site staff to ensure appropriate conduct of clinical trials, driving improvement in data integrity, compliance, and overall study performance.
Role type
Senior Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical trial execution and data integrity for AbbVie's investigational drug and device pipeline
Domain
Biopharmaceuticals / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Site evaluation and training, routine on-site and off-site monitoring, risk-based monitoring, patient recruitment and retention strategies, regulatory compliance (ICH/GCP), mentorship of junior CRAs, data quality assurance, investigator selection
Preferred skills
Tertiary qualification in health-related disciplines (Medical, Scientific, Pharmacy, Nursing), advanced therapeutic area knowledge, global/local task force participation
Technologies
Site engagement tools, monitoring software
Responsibilities
Conduct site evaluation, training, and closure monitoring activities; align and train site staff and principal investigators on trial goals and protocols; mentor and train less experienced CRAs; proactively assess risks and resolve site risk signals; identify and recommend new potential investigators and sites; ensure quality and timely submission of data from study sites
Seniority
Senior, hands-on IC with mentorship responsibilities