Senior Clinical Research Associate
Core
Senior Clinical Research Associate leading site management, monitoring, and investigator engagement to ensure trial compliance, data integrity, and patient safety for AbbVie's clinical pipeline.
Role type
Senior Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical trials for investigational drugs/devices
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
Site evaluation and selection, On-site and off-site monitoring, Protocol compliance, Risk-based monitoring, 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 monitoring experience, Therapeutic area expertise
Technologies
Clinical trial management tools, Site engagement platforms
Responsibilities
Conduct routine on-site and off-site monitoring to ensure protocol compliance and data integrity; Develop and execute site engagement strategies to optimize recruitment and retention; Mentor and train junior CRAs and site staff; Identify and evaluate potential investigators and sites; Manage investigator payments and ensure audit readiness; Proactively assess and mitigate site risks to protect patient safety.
Seniority
Senior, hands-on IC with mentorship responsibilities