Clinical Research Associate, South West England
Core
Conduct site monitoring visits (selection, initiation, monitoring, close-out) to ensure study adherence to protocols and regulatory guidelines.
Role type
Clinical Research Associate (IC)
Builds
Clinical trials for life sciences and healthcare industries
Domain
Clinical research / Healthcare
Required skills
Site monitoring, subject recruitment management, protocol administration, regulatory compliance (GCP/ICH), TMF/ISF management, data query resolution, study progress tracking
Preferred skills
AI tool proficiency, start-up phase support
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; Collaborate with study team members
Seniority
Mid-level, hands-on IC