Clinical Research Associate
Core
Primary face of clinical studies at assigned sites, ensuring excellence from start-up through close-out by training site teams, monitoring data integrity, and managing drug supplies.
Role type
Senior Clinical Research Associate (Field-based)
Builds
Clinical trials for life-changing medicines
Domain
Biopharmaceuticals / Cell and Gene Therapies
Deliverable
client delivery
Required skills
ICH-GCP knowledge, late-phase trial monitoring (2-4), study drug handling, source data verification, risk-based quality management, regulatory submission support, site network building
Preferred skills
Cell and gene therapy experience, remote monitoring familiarity, change management, analytical problem-solving
Technologies
CTMS, eTMF
Responsibilities
Lead start-up and regulatory maintenance including Site Qualification Visits and EC/IRB submissions; Train and advise Investigators on study requirements and Risk Based Quality Management; Initiate, monitor, and close study sites via remote and onsite visits; Perform Source Data Review and Case Report Form review; Ensure accurate reporting of Serious Adverse Events; Manage study and drug supplies at sites; Prepare monitoring visit reports and finalize eTMF documentation; Collaborate during audits and regulatory inspections.
Seniority
Mid-to-Senior, hands-on IC