Clinical Research Associate (CRA)
Core
Field-based Clinical Research Associate ensuring quality, integrity, and compliance of clinical trial sites across all phases.
Role type
Field-based Clinical Research Associate (CRA)
Builds
Clinical trials for innovative medicines
Domain
Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Site qualification and monitoring, data verification, regulatory compliance (ICH GCP), risk assessment, site selection, study drug oversight, audit support, remote monitoring
Preferred skills
Prior Pharma/Biotech Sponsor experience, clinical study coordination, drug discovery/development process knowledge
Technologies
CTMS, eDC, eTMF, RBM tools (Veeva, Medidata, CluePoints), Microsoft Suite
Responsibilities
Conduct site qualification, initiation, routine monitoring, and close-out visits; verify data integrity in electronic and paper systems; monitor adherence to ICH GCP and local regulations; cultivate relationships with sites and stakeholders; motivate sites to meet enrollment and retention goals; prepare monitoring and administrative reports; assess potential investigators and sites; support regulatory compliance audits and inspections; manage study drug/IMP reconciliation; coordinate database locks and site closure activities.
Seniority
Mid-level, independent contributor
