Job Information
IQVIA Experienced Clinical Research Associate in Reading, United Kingdom
Our Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forward!
Why IQVIA?
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
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
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
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement
Requirements
You should be life science degree educated
You have experience of independent on-site monitoring experience
You've handled multiple protocols and sites across a variety of drug indications
Flexibility and ability to travel
Strong communication, written and presentation skills
#LI-remote #LI-AdamThompson
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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 https://jobs.iqvia.com
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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