Senior Clinical Research Associate - Oncology, CNS, Rare Disease - UK
Core
Ensuring clinical research programs are executed with quality and excellence by managing site visits, monitoring protocol adherence, and verifying data for oncology, CNS, and rare disease trials.
Role type
Senior Clinical Research Associate (Oncology, CNS, Rare Disease)
Builds
Clinical trial execution for pharmaceutical sponsors
Domain
Clinical Research / Oncology / CNS / Rare Disease
Deliverable
client delivery
Required skills
Site qualification, initiation, interim monitoring, site management, study close-out, source document verification, CRF review, data query resolution, TMF documentation, IP accountability, protocol adherence training
Preferred skills
Mentoring less experienced CRAs and site staff
Technologies
Electronic data capture systems
Responsibilities
Conduct site qualification, initiation, interim monitoring, site management, and study close-out visits; Document site visit findings via written reports; Assess, monitor, and train study site staff on protocol adherence; Review study subject safety information and informed consent; Conduct source document verification for compliance, patient safety, and data veracity; Review CRFs and assist sites with data query resolution; Provide updates for site-related documentation for the Trial Master File; Ensure site compliance with IP receipt, accountability, and return or destruction; Conduct accompanied site visits for assessment or training.
