Clinical Research Associate II
Core
Proactively solves study-related clinical site issues to ensure successful protocol execution for Phase 1-4 clinical studies.
Role type
Mid-level Clinical Research Associate (monitoring)
Builds
Clinical study deliverables (start-up, execution, close-out)
Domain
Biopharmaceuticals / Clinical Research (via careerplan.io/jobs/3743990015818206-clinical-research-associate-ii-at-abbvie)
Required skills
On-site monitoring of investigational drug/device trials, Regulatory compliance (ICH/GCP), Site qualification and initiation, Safety event reporting, Investigator payment management, Site selection and networking
Preferred skills
Experience in therapeutic indications, Planning and organizational skills, Analytical capabilities
Technologies
None stated
Responsibilities
Monitor clinical investigative sites for protocol adherence and regulatory compliance; Conduct site qualification, initiation, interim monitoring, and closeout visits; Ensure quality and timely submission of data and safety event reports; Train study site personnel on protocol and regulations; Manage investigator payments and negotiate agreements; Identify and evaluate potential investigators/sites.
Seniority
Junior to Mid-level, hands-on IC