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Senior Clinical Research Associate (CRA III)

syneoshealth · NOR-Client

New
Senior 🇬🇧 English
Good Clinical Practice ICH guidelines Good Pharmacoepidemiology Practice electronic data capture

Job description

About the role

The Senior Clinical Research Associate (CRA III) will support site qualification, initiation, monitoring and close‑out activities for real‑world late‑phase studies, ensuring compliance with ICH‑GCP, Good Pharmacoepidemiology Practice and protocol requirements.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, and close‑out visits, both on‑site and remotely.
  • Review source documents, verify CRF data accuracy, and resolve queries within agreed timelines.
  • Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
  • Maintain Investigator Site File and ensure alignment with the Trial Master File.
  • Document activities through trip reports, confirmation letters and other required project documents.
  • Support subject recruitment, retention strategies and assist with audit readiness.

Required profile

  • Bachelor’s degree or RN in a related field, or equivalent experience.
  • Knowledge of Good Clinical Practice, ICH guidelines and applicable regulatory requirements.
  • Ability to travel up to 75% of the time.
  • Strong communication, presentation and interpersonal skills.

Required skills

  • Good Clinical Practice (GCP) and ICH guideline compliance.
  • Good Pharmacoepidemiology Practice (GPP) knowledge.
  • Electronic data capture systems and case report form (CRF) review.
  • Investigational product handling and inventory management.

Questions fréquentes

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Source : ats:workday

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Published 2 timer siden

Expires om 1 måned

2 views · 0 interested

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syneoshealth

NOR-Client