Clinical Research Associate
Core
Executes clinical monitoring activities at trial sites to ensure data quality and regulatory compliance for oncology/hematology clinical trials.
Role type
Clinical Research Associate (CRA)
Builds
Oncology/hematology clinical trials
Domain
Life Sciences / Clinical Research
Required skills
Clinical trial monitoring, ICH-GCP guidelines, Site selection and evaluation, Protocol training, Data query resolution, Regulatory submission tracking, CAPA proposal, Inspection readiness
Preferred skills
Oncology/hematology trial experience, SSU experience
Technologies
Microsoft Word, Excel, MS Project, MS PowerPoint, Outlook
Responsibilities
Perform feasibility, site identification, selection, and evaluation; Conduct pre-study, initiation, routine, and closeout monitoring visits; Manage site performance by tracking recruitment and CRF completion; Ensure inspection readiness and facilitate study oversight visits; Propose corrective and preventative actions for quality gaps.
Seniority
Mid-level, hands-on IC
