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Clinical Research Associate - Denmark

syneoshealth · DNK-Remote

New
Mid 🇬🇧 English
ICH-GCP Source document review Electronic data capture

Job description

About the role

Syneos Health is recruiting an experienced Clinical Research Associate (CRA) for its multi-sponsor business unit in Denmark. The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, and ensures regulatory, ICH-GCP and protocol compliance.

Key responsibilities

  • Evaluate site and site staff performance, escalate serious issues and develop action plans
  • 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 return
  • Review the Investigator Site File, reconcile it with the Trial Master File and document site activities
  • Support recruitment and retention, enter tracking data and manage site-level communication
  • Act as liaison with sites, prepare for and attend investigator meetings and sponsor meetings, and support audit readiness

Required profile

  • Bachelor's degree or RN in a related field, or equivalent education, training and experience
  • Previous monitoring experience
  • Fluency in Danish and English; Swedish and Norwegian preferred
  • Ability to travel regularly up to 75%, with possible cross-border monitoring in the Nordics

Required skills

  • Good computer skills and openness to new technologies
  • Knowledge of ICH-GCP and other regulatory requirements
  • Excellent communication, presentation and interpersonal skills

Questions fréquentes

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Source : ats:workday

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Published for 2 dage siden

Expires om 1 måned

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syneoshealth

DNK-Remote