IQVIA
Clinical Research Associate
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Clinical Research Associate – Oncology (Site Management, Multi-Sponsor) at IQVIA
IQVIA's Site Management (multi-sponsor) team are seeking a Clinical Research Associate to join us in helping create a healthier world. The Clinical Research Associate will specialise in supporting Oncology studies and cover sites across the UK.
Apply today and forge a career with greater purpose, make an impact and never stop learning!
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice (GCP).
- Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites, and establish regular lines of communication to manage expectations and address issues.
- Evaluate the quality and integrity of study site practices, ensuring compliance with regulations and protocol adherence. Escalate quality issues as appropriate.
- Manage study progress by tracking:
- Regulatory submissions and approvals
- Recruitment and enrollment
- Case report form (CRF) completion and submission
- Data query generation and resolution
- May support the start-up phase of studies.
- 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) complies with GCP and local regulatory requirements.
- Create and maintain study documentation, including:
- Regular visit reports
- Follow-up letters
- Other required study materials
- Collaborate with study team members to support project execution as needed.
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Requirements
- Proven experience in independent on-site monitoring of Oncology studies (unblinded studies preferred).
- In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Life sciences degree (or equivalent industry experience).
- Willingness to travel to sites as required.
- Please note: This role is not eligible for visa sponsorship.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. Our mission is to accelerate the development and commercialisation of innovative treatments to improve patient outcomes and global population health.
Learn more about opportunities at IQVIA: https://jobs.iqvia.com
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