CRA II, Oncology
Core
Conduct independent on-site monitoring visits for clinical trials to ensure protocol adherence and data integrity across diverse investigative sites.
Role type
Clinical Research Associate (Oncology)
Builds
Clinical trial data and regulatory compliance for life sciences sponsors
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Independent on-site monitoring, GCP and ICH guidelines knowledge, multi-protocol management, site recruitment tracking, regulatory submission management, TMF/ISF maintenance, data query resolution
Preferred skills
Oncology domain expertise
Technologies
Trial Master File (TMF), Investigator's Site File (ISF), Case Report Forms (CRF)
Responsibilities
Perform site monitoring visits (selection, initiation, monitoring, close-out), drive subject recruitment plans, administer protocol training, evaluate site practice quality, track regulatory submissions and enrollment, maintain site documentation, generate visit reports and action plans
Seniority
Mid-level, hands-on IC
