Sr. Clinical Research Associate
Core
Support pre-market clinical studies of investigational drugs for the Fluorescence Imaging group, ensuring regulatory compliance and data accuracy.
Role type
Senior Clinical Research Associate (IC)
Builds
Pre-market clinical studies for investigational drugs
Domain
Biopharmaceuticals / Clinical Trials
Deliverable
client delivery
Required skills
Clinical trial management, Good Clinical Practice (GCP), regulatory compliance, site qualification, source data verification, EDC systems, protocol development, audit preparation, budget negotiation
Preferred skills
Surgical trial experience, hospital environment experience, statistics knowledge
Technologies
EDC systems, CTMS, eTMF, Microsoft Office Suite
Responsibilities
Conduct co-monitoring visits (SIV, interim, close-out), verify source data, manage site start-up and activation, prepare for and assist in audits, support IRB submissions and amendments, manage study documentation
Seniority
Senior, hands-on IC
