Clinical Research Associate (CRA II / Senior) – Oncology
syneoshealth · ROU-Bucharest-Hybrid
Job description
About the role
Syneos Health is seeking a Clinical Research Associate (CRA II / Senior) to support multi‑sponsor oncology studies. The role involves on‑site and remote monitoring activities across the study lifecycle, ensuring compliance with regulatory and protocol requirements.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, management and close‑out visits, both on‑site and remotely.
- Verify informed consent, protect patient confidentiality, and assess safety and data integrity issues.
- Conduct source document review, ensure accurate CRF entry, and drive query resolution.
- Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
- Maintain Investigator Site File accuracy, reconcile with Trial Master File, and support audit readiness.
- Support subject recruitment, retention, and awareness strategies; track observations and actions in study systems.
- Collaborate with study sites, central monitoring associates, and sponsor affiliates; attend investigator and sponsor meetings.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent experience.
- Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
- Excellent communication, presentation and interpersonal skills.
- Ability to travel up to 75% of the time.
Required skills
- Good computer proficiency and willingness to adopt new technologies.
- Understanding of regulatory requirements and company SOPs.
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syneoshealth
ROU-Bucharest-Hybrid
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