Unblinded Clinical Research Associate I
Core
Conduct site monitoring and management for unblinded clinical studies, ensuring protocol adherence, data integrity, and patient safety across clinical trial sites.
Role type
Junior Clinical Research Associate (Unblinded Monitoring)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/medical device studies
Domain
Clinical Research / Pharmaceutical / Medical Devices
Required skills
Clinical trial monitoring, Source document review, Case Report Form (CRF) review, Serious Adverse Event (SAE) reporting, Regulatory guideline knowledge, Site management, Travel logistics, Vendor liaison, Data query resolution, Study file maintenance
Preferred skills
Clinical trial management system (CTMS) experience, ICH GCP/ISO 14155 knowledge, Medical/clinical research terminology, Physiology/pharmacology basics, Local office language fluency, Microsoft Office proficiency
Technologies
Fortrea, Client data management systems, Microsoft Office, CTMS
Responsibilities
Perform routine and closeout monitoring visits, verify informed consent and protocol adherence, review source documents and CRFs for data accuracy, track and report Serious Adverse Events, manage clinical trial supplies and vendors, prepare trip reports, assist with investigator recruitment and EC submissions, mentor new employees, coordinate local project activities.
Seniority
Entry-level, supervised IC
