Amsterdam
1 day ago
Temporary CRA II position - Sponsor dedicated - Based in Netherlands
Syneos Health
Amsterdam
1 day ago
Temporary CRA II position - Sponsor dedicated - Based in Netherlands
Temporary CRA II position for a sponsor-dedicated role based in the Netherlands. The role involves site management, monitoring, and ensuring regulatory compliance for clinical trials. Requires a Bachelor's degree or RN and knowledge of GCP/ICH guidelines.
RemoteFull-timeEntry LevelGood Clinical PracticeICH Guidelines
Temporary CRA II position - Sponsor dedicated - Based in Netherlands
Temporary CRA II position for a sponsor-dedicated role based in the Netherlands. The role involves site management, monitoring, and ensuring regulatory compliance for clinical trials. Requires a Bachelor's degree or RN and knowledge of GCP/ICH guidelines.
RemoteFull-timeEntry LevelGood Clinical Practice
Salary
Not specified
Core Qualifications
Technical (Must-have)
Good Clinical PracticeICH GuidelinesRegulatory ComplianceSite ManagementClinical MonitoringSource Document ReviewQuery ResolutionElectronic Data CaptureInvestigational Product ManagementTrial Master FileCommunicationPresentationInterpersonal Skills
Soft Skills
CommunicationPresentationInterpersonal SkillsAdaptabilityProblem Solving
Key Responsibilities
- Performs site qualification, initiation, interim monitoring, site management and close-out visits.
- Verifies informed consent process and subject confidentiality.
- Conducts Source Document Review and verifies CRF data accuracy.
- Applies query resolution techniques and drives closure.
- Performs IP inventory, reconciliation, and reviews storage and security.
- Reviews Investigator Site File and reconciles with TMF.
- Documents activities via letters, reports, and logs.
- Supports subject recruitment and retention strategies.
- Manages site-level activities to meet project objectives.
- Acts as primary liaison with study site personnel.
- Prepares for and attends Investigator Meetings.
- Provides guidance for audit readiness.
- Maintains working knowledge of ICH/GCP and regulations.
CRAClinical ResearchClinical MonitoringTemporaryNetherlandsRemoteSyneos HealthBiotechnologyGCPICH