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- Growth potential - clear pathways to success for those who want to grow with us
- Professional development - resources that promote your career growth and programs to help you build knowledge and gain skills
- Work-life balance - leaders that support flexible work schedules
- Variety - dynamic work environments that expose you to new experiences
- Collaboration - teams that work together to achieve common goals
- 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
- Ensure copies/originals (as required) 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
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Collaborate and liaise with study team members for project execution support as appropriate
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
- Experience of independent on-site monitoring on UK Phase 1 studies
- You've handled multiple protocols and sites across a variety of drug indications
- You should be life science degree educated or equivalent industry experience
- Flexible to travel to sites as required
Senior CRA - Reading, United Kingdom - IQVIA
Description
Our cFSP (sponsor dedicated) team are growing; join us on our mission to drive healthcare forward
We are recruiting for a Senior Clinical Research Associate to assist our sponsor's Early Development team (phase 1).
This is a fully remote position (open to candidates anywhere in the UK) with travel to sites.
Why IQVIA?
Responsibilities
Requirements
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at