CRA II / Sr CRA – Sponsor Dedicated (Athens)
syneoshealth · GRC-Athens
Περιγραφή θέσης
About the role
Syneos Health is seeking a CRA II / Sr CRA to support sponsor‑dedicated studies in Athens. The role involves on‑site and remote monitoring activities across the full study lifecycle, ensuring compliance with regulatory and protocol requirements.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, management and close‑out visits, either on‑site or remotely.
- Verify informed consent, protect patient confidentiality, and assess safety and data integrity issues.
- Conduct source document review, ensure accurate CRF entry, and resolve queries within agreed timelines.
- 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, and track observations in study systems.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent education and experience.
- Knowledge of Good Clinical Practice (GCP) and ICH guidelines, and applicable regulatory requirements.
- Ability to travel up to 75% of the time.
- Excellent communication, presentation and interpersonal skills.
Required skills
- Good Clinical Practice (GCP) / ICH‑GCP knowledge.
- Electronic Data Capture (EDC) systems proficiency.
- Source document review and CRF data entry.
- Investigational product handling and inventory management.
- Query resolution techniques.
- Computer literacy and ability to adopt new technologies.
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syneoshealth
GRC-Athens
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