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Clinical Research Associate

2 months ago

Reading, Reading, United Kingdom IQVIA, Inc. Full time
Job Title: Clinical Research Associate

IQVIA UK is seeking a Clinical Research Associate to strengthen our cFSP (sponsor dedicated) business unit.

Responsibilities:
  1. Perform site monitoring visits to ensure compliance with contracted scope of work and regulatory requirements.
  2. Work with sites to adapt and track subject recruitment plans to enhance predictability.
  3. Administer protocol and related study training to assigned sites and establish regular communication to manage ongoing project expectations and issues.
  4. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  5. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.
  6. Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
  7. Create and maintain documentation regarding site management, monitoring visit findings, and action plans.
  8. Collaborate with study team members for project execution support as appropriate.
Requirements:
  1. Experience of independent on-site monitoring in the UK.
  2. Monitoring experience of Oncology, Cardiovascular, Respiratory, Diabetic, Immunology, or Renal therapeutic areas.
  3. Life science degree educated or equivalent industry experience.
  4. UK driving license and flexibility to travel to sites as required.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide. Learn more at IQVIA Careers.