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

syneoshealth · LVA-Remote

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

Job description

About the role

Syneos Health is hiring a remote, sponsor-dedicated Clinical Research Associate II (CRA II) for Latvia. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and ensures 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, evaluating site performance and escalating serious issues
  • 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, labelling and release, and reconcile the Investigator Site File with the Trial Master File
  • Support recruitment and retention, enter tracking data, and prepare sites for audits
  • Attend investigator and sponsor meetings, clinical training and global project meetings
  • For Real World Late Phase: site support throughout the study lifecycle, chart abstraction, data collection and collaboration 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
  • Good computer skills and willingness to adopt new technologies
  • Excellent communication, presentation and interpersonal skills
  • Ability to travel regularly up to 75%

Required skills

  • Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
  • Working knowledge of ICH/GCP guidelines, regulations and company SOPs

Questions fréquentes

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Source : ats:workday

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syneoshealth

LVA-Remote