Senior Clinical Research Associate - Remote- North Carolina
Core
Ensures appropriate conduct of clinical trials at investigative sites, driving data integrity, compliance, and patient safety while managing site engagement and recruitment strategies.
Role type
Senior Clinical Research Associate (Site Management)
Builds
Clinical trial execution and site partnerships for AbbVie's pipeline
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
Site evaluation and training, routine on-site and off-site monitoring, site closure monitoring, risk assessment, investigator identification, data quality assurance, regulatory inspection readiness, investigator payment management, patient recruitment and retention planning, mentorship of junior CRAs
Preferred skills
Tertiary qualification in health-related disciplines (Medical, Scientific, Pharmacy, Nursing), 3+ years of clinically related experience (2+ in independent monitoring), familiarity with risk-based monitoring, knowledge of therapeutic area indications, understanding of ICH/GCP Guidelines and local regulatory requirements
Technologies
Site engagement tools, monitoring software
Responsibilities
Conduct site evaluation, training, and closure monitoring; align and train site staff and principal investigators on trial goals; proactively assess risks and resolve site risk signals; identify and recommend new investigators/sites; ensure quality of data submission and safety event reporting; manage investigator payments; support onboarding of junior CRAs
Seniority
Senior, hands-on IC with mentorship responsibilities
