Experienced Clinical Research Associate, Multi Sponsor
Core
Conduct clinical monitoring visits (qualification, initiation, monitoring, closeout) at research sites to ensure protocol compliance and data accuracy.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for biotechnology, pharmaceutical, and medical device clients
Domain
Clinical Research / Life Sciences
Deliverable
physical/clinical work
Required skills
Clinical trial monitoring, protocol deviation management, source data verification, adverse event reporting, site qualification, regulatory document review, patient recruitment assessment
Preferred skills
CRA certification (DMC 15/11/2011), Microsoft Office proficiency, strong communication and presentation skills
Technologies
Microsoft Office
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits at research sites; Verify investigator qualifications, training, and resources; Review medical records and source documentation against case report forms; Verify investigator enrollment of eligible subjects; Review regulatory documents; Ensure accountability of medical devices and investigational products; Verify and review adverse events and concomitant medications; Assess patient recruitment and retention success; Complete monitoring reports and follow-up letters
Seniority
Mid-level, experienced IC