CRA2 - Multi-Sponsor Department
Core
Perform site monitoring visits (selection, initiation, monitoring, close-out) and manage clinical trial protocols across diverse investigative sites to ensure adherence to GCP and ICH guidelines.
Role type
Clinical Research Associate (Site Management)
Builds
Clinical trial data integrity and regulatory compliance for life sciences sponsors
Domain
Life sciences / Clinical research
Required skills
Independent on-site monitoring, multi-protocol management, GCP/ICH guidelines knowledge, site recruitment planning, regulatory submission tracking, TMF/ISF maintenance, data query resolution
Preferred skills
Life science degree, flexibility to travel
Technologies
Trial Master File (TMF), Investigator's Site File (ISF), Case Report Forms (CRF)
Responsibilities
Conduct site monitoring visits, drive subject recruitment plans, administer protocol training, evaluate site practice quality, track regulatory submissions and enrollment, maintain study documentation, collaborate with study teams
Seniority
Junior to Experienced
