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Clinical Research Associate II - Sponsor-Dedicated, Remote (Slovakia)

syneoshealth · SVK-Remote

New Remote
Remote Mid 🇬🇧 English
ICH-GCP Source document review Chart abstraction

Job description

About the role

Syneos Health is hiring a CRA II for a sponsor-dedicated, remote position based in Slovakia. The role covers site qualification, initiation, interim monitoring, site management and close-out, ensuring regulatory, ICH-GCP and protocol compliance. For Real World Late Phase studies, the title used is Site Management Associate II.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, site management and close-out visits, on-site or remotely, and escalate serious issues to the project team
  • Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
  • Review source documents and CRFs, resolve queries and verify electronic data capture compliance
  • Check investigational product inventory, dispensing and administration, and ensure proper labelling, import and release
  • Review the Investigator Site File and reconcile it with the Trial Master File
  • Document activities, support recruitment and retention, and enter data into tracking systems
  • Act as liaison with sites, prepare for investigator meetings and support audit readiness
  • Support site support throughout the study lifecycle, chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons and local country staff

Required profile

  • Bachelor's degree or RN in a related field, or equivalent education, training and experience
  • Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements
  • Ability to manage travel of up to 75% regularly
  • Excellent communication, presentation and interpersonal skills

Required skills

  • Good computer skills and willingness to adopt new technologies
  • ICH-GCP knowledge

Questions fréquentes

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Source : ats:workday

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Published pred 6 hodinami

Expires o 1 mesiac

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syneoshealth

SVK-Remote