Clinical Research Associate/Senior Clinical Research Associate- FSP
Core
Managing clinical trial sites to ensure study conduct compliance with ICH-GCP and local regulations, overseeing site initiation, monitoring, and closure for oncology and cell therapy studies.
Role type
Senior Clinical Research Associate (Oncology/Cell Therapy)
Builds
Clinical trials for oncology and cell therapy products
Domain
Life Sciences / Clinical Research / Oncology
Deliverable
client delivery
Required skills
Site management, ICH-GCP compliance, Source Data Verification (SDV), Case Report Form (CRF) review, Serious Adverse Event reporting, Risk Based Quality Management (RbQM), drug accountability, investigator training, regulatory submission support
Preferred skills
Remote monitoring, risk-based monitoring approach, change management, process improvement, analytical problem-solving, multi-tasking
Technologies
CTMS, eTMF
Responsibilities
Conduct remote and onsite monitoring visits, perform source data reviews and data checks, manage study supplies and drug accountability, ensure site inspection readiness, resolve data queries, report Serious Adverse Events, prepare monitoring visit reports, support regulatory submissions and audits
Seniority
Senior, hands-on IC