Job Description:
General Description:
The CRA executes clinical trial protocols at clinical trial sites and monitors clinical trials by ICH guidelines and GCP, local regulations, and applicable SOPs. The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Pharma clinical trials within the assigned region(country).Accountable for the study start-up timelines and delivery.Essential Functions of the job:
Conducts monitoring (pre-study, initiation, routine monitoring, and closeout visit), if requireConducts co-monitoring visits, if requiredAssists with investigator/site identificationAssists site to prepare Institutional Review Board/Ethics Committee (IRB/EC) submissionsFacilitates clinical trial site contract and budget negotiationManages site queries and communicationsAssists ...