Clinical Research Associate - IQVIA BIOTECH (homebased in Paris)
Core
Conduct site monitoring visits (selection, initiation, monitoring, close-out) for clinical trials to ensure adherence to GCP and ICH guidelines.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for biotech partners
Domain
Biotechnology / Clinical Research
Deliverable
client delivery
Required skills
Site monitoring, subject recruitment tracking, protocol administration, regulatory compliance (GCP/ICH), TMF/ISF management, data query resolution, site document management
Preferred skills
Life Science/Nursing/Pharmacy/Medical background, oncology therapy area experience, CRA training certification
Technologies
Trial Master File (TMF), Investigator's Site File (ISF), Case Report Forms (CRF)
Responsibilities
Perform site monitoring visits, drive subject recruitment plans, administer protocol training, evaluate site practice quality, manage study progress (submissions, enrollment, CRF completion), maintain site documentation, liaise with study teams, support financial management
Seniority
Entry-level to Mid-level, hands-on IC