Sr. CRA 1, IQVIA
Core
Perform site monitoring and management to ensure clinical studies are conducted per protocol and regulations, managing recruitment and data integrity.
Role type
Senior Clinical Research Associate (monitoring)
Builds
Clinical trial data and regulatory compliance
Domain
Life sciences / Clinical research
Required skills
Site monitoring, GCP compliance, Protocol adherence, Subject recruitment management, Regulatory submissions, TMF/ISF management, Data query resolution, Therapeutic area knowledge
Preferred skills
Bachelor's in scientific discipline or healthcare, 2+ years on-site monitoring experience, Knowledge of oncology, cardiovascular, renal, metabolic, CNS, Obesity, diabetes, GI, MASH/NASH, dermatology, or respiratory
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 to sites, Evaluate site quality and adherence to GCP, Track regulatory submissions and enrollment, Maintain TMF and ISF documentation, Generate visit reports and action plans
Seniority
Mid-level, hands-on IC