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Senior Clinical Research Associate

3 weeks ago

Reading, Reading, United Kingdom IQVIA Argentina Full time

IQVIA are seeking a Senior Clinical Research Associate to join our sponsor-dedicated team and support sites across Ireland and Northern Ireland.

Excellent opportunity for CRAs local to Ireland or Northern Ireland who would value:

  • Supportive leadership and collaborative teams
  • A variety of career opportunities to allow you to grow as we grow
  • Technology-enabled resources that make doing your job more efficient

Responsibilities

  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase

Requirements

  • 2-3 years minimum experience of independent on-site monitoring
  • In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Life science degree educated or equivalent industry experience
  • Flexibility to travel to sites across Ireland and Northern Ireland

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