Senior Clinical Research Associate
Core
Senior Clinical Research Associate supporting 2–3 clinical trials with site monitoring, study start-up, and data quality assurance for pharmaceutical, biotechnology, and medical device clients.
Role type
Senior IC Clinical Research Associate (Site Monitoring)
Builds
Clinical trial data integrity and regulatory compliance for drug/device development
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Site monitoring, study start-up, source data verification, safety reporting (AE/SAE/SUSAR), investigational product management, GCP/ICH guidelines knowledge, CRA coaching
Preferred skills
Feasibility assessment, contract negotiation support, CRF design, broad therapeutic area experience
Technologies
Microsoft Office (Word, Excel, Outlook), Trial Master File (TMF), Case Report Forms (CRF)
Responsibilities
Conduct on-site and remote monitoring visits including initiation, periodic, and close-out visits; verify source data and resolve queries; manage investigational products and trial materials; train site staff and supervise junior CRAs; report safety issues and ensure timely handling; support study start-up and submission processes.
Seniority
Senior, hands-on IC with mentorship responsibilities