Clinical Research Associate 2 - IQVIA Biotech
Core
Conduct site monitoring visits (selection, initiation, monitoring, close-out) for clinical trials in biotech and emerging biopharma companies to ensure protocol adherence and data integrity.
Role type
Clinical Research Associate (Site Monitoring)
Builds
Clinical trial data and regulatory compliance for biotech and emerging biopharma clients
Domain
Life Sciences / Clinical Research
Deliverable
physical/clinical work
Required skills
Site monitoring, GCP/ICH guidelines knowledge, subject recruitment tracking, protocol administration, regulatory submission tracking, CRF management, TMF/ISF maintenance, site financial management
Preferred skills
Oncology, Hematology, or Cardiovascular therapeutic area experience
Technologies
Trial Master File (TMF), Investigator's Site File (ISF), Case Report Forms (CRF)
Responsibilities
Perform site monitoring visits in accordance with GCP and ICH guidelines; Drive and track subject recruitment plans; Administer protocol training to sites; Evaluate quality and integrity of site practices; Manage study progress including regulatory submissions and data queries; Maintain site documentation and visit reports; Support site financial management and invoice retrieval.
Seniority
Mid-level, hands-on IC