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Clinical Research Associate (CRA II / Senior) – Oncology

syneoshealth · ROU-Bucharest-Hybrid

New
Hybrid Senior 🇬🇧 English
ICH guidelines Clinical monitoring

Job description

About the role

Syneos Health is seeking an experienced 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 standards and study protocols.

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, and document all monitoring activities.

Required profile

  • Bachelor’s degree or RN in a related field, or equivalent experience.
  • Strong knowledge of Good Clinical Practice (GCP) and ICH guidelines.
  • Excellent communication, presentation and interpersonal skills.
  • Willingness to travel up to 75% of the time.

Required skills

  • Good Clinical Practice (GCP) compliance
  • ICH guideline familiarity
  • Clinical monitoring and site management
  • Electronic data capture (EDC) systems
  • Investigational product handling

Questions fréquentes

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Source : ats:workday

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Published 9 ore în urmă

Expires peste 1 lună

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syneoshealth

ROU-Bucharest-Hybrid