Clinical Research Associate

1 day ago

Reading, Reading, United Kingdom IQVIA, Inc. Full time
Senior Clinical Research Associate (SR CRA II) Job Description

IQVIA UK is seeking a highly skilled Senior Clinical Research Associate (SR CRA II) to join our cFSP team. As a key member of our team, you will be responsible for performing site monitoring visits, working with sites to adapt and drive subject recruitment plans, and ensuring the quality and integrity of study site practices.

Key Responsibilities:
  • Site Monitoring: Perform site monitoring visits to ensure compliance with contracted scope of work and regulatory requirements.
  • Subject Recruitment: Work with sites to adapt and drive subject recruitment plans to enhance predictability.
  • Protocol Training: Administer protocol and related study training to assigned sites and establish regular lines of communication.
  • Quality Assurance: Evaluate the quality and integrity of study site practices and escalate quality issues as appropriate.
  • Study Progress: Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, and data query generation and resolution.
  • Documentation: Ensure copies/originals of 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.
  • Collaboration: Collaborate and liaise with study team members for project execution support as appropriate.
Requirements:
  • Experience: Experience of independent on-site monitoring in the UK.
  • Therapeutic Area: Monitoring experience of Oncology, Cardiovascular, Respiratory, Diabetic, Immunology, or Renal therapeutic areas.
  • Education: Life science degree educated or equivalent industry experience.
  • Travel: UK driving license and access to vehicle (excluding London travel zones 1 & 2) 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 help improve patient outcomes and population health worldwide.

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