Clinical Research Associate II
Core
Proactively solves study-related clinical site issues and ensures successful protocol execution for Phase 1-4 clinical studies.
Role type
Clinical Research Associate II (IC)
Builds
Clinical studies (start-up, execution, close-out) for AbbVie R&D
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
On-site monitoring of investigational drug/device trials, Site qualification and initiation, Study closeout, Regulatory compliance (GCP/ICH), Data quality assurance, Safety event reporting, Investigator payment management, Site identification and evaluation
Preferred skills
Therapeutic area knowledge, Networking for site placement
Technologies
None stated
Responsibilities
Monitor clinical investigative sites for protocol adherence, Conduct site qualification/initiation/interim monitoring/closeout visits, Ensure regulatory inspection readiness, Train study site personnel on protocols, Manage investigator payments and agreements, Identify and evaluate new potential investigators/sites
Seniority
Mid-level, hands-on IC