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Clinical Research Associate II (Remote)

icon · Bucharest

New Remote
Remote Mid 🇬🇧 English
ICH-GCP Site Initiation Visits Site Qualification Visits Clinical trial monitoring

Job description

About the role

ICON Strategic Solutions is hiring a Clinical Research Associate (CRA I or CRA II) for a single client dedicated role with one of its top 5 pharmaceutical clients. The position is remote and involves delivering clinical trial monitoring work to a high standard within a sponsor-dedicated model, supported by ICON's global expertise.

Key responsibilities

  • Coordinate all activities for setting up and monitoring a study, complete accurate study status reports and maintain study documentation
  • Run monitoring activities and run sponsor-generated queries efficiently
  • Take responsibility for study cost efficiency
  • Participate in preparing and reviewing study documentation and feasibility studies for new proposals
  • Build strong relationships with stakeholders, clinical investigators and site staff
  • Ensure patient safety by complying with ICON's procedures, protocols and regulatory requirements

Required profile

  • University degree in medicine, science or equivalent
  • Clinical research associate experience
  • Experience conducting independent on-site monitoring visits and Site Initiation Visits (SIVs)
  • Experience with Site Qualification Visits (SQVs) is preferred but not mandatory
  • Willingness to travel approximately 60% of the time
  • Legal right to work in the country where the role is based

Required skills

  • Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
  • Excellent written and verbal English
  • Good social skills for handling queries promptly

What we offer

  • Competitive base salary and performance-related incentives
  • Health and wellbeing programmes, including medical, dental and vision coverage where applicable
  • Retirement and pension plans, life assurance and disability coverage
  • Employee assistance programmes and learning and development opportunities

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Source : ats:workday

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