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.
For our sponsor dedicated department in the UK we are currently looking to further strengthen our team with CRAs / Senior CRAs to join us on a permanent contract to be dedicated to one client, a major pharmaceutical company well known in the market for over 60 years for their innovation within the specialty care area.
The role can be based anywhere in the United Kingdom (England, Wales and Scotland preferably) and would report to a DLM (Direct Line Manager) within IQVIA's amazing management team!
Essential Functions of a Clinical Research Associate
- 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) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH 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.
- Bachelor's Degree or Master's Degree, ideally in scientific discipline or healthcare
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
- Minimum of 9/12 months of independent on site monitoring experience, ideally in the UK
- Written and verbal communication skills including good command of English language
- Driving license valid in the UK
Why should you apply?
- You'd join a global team of 70.000+ brave minds
- In 2019 we completed almost 4.000 recruitment processes internally; once you join us, not even the sky is the limit
- We've been nominated a top 500 company every year since our inception in 2016
- FLEXJOBS awarded us the 9th spot in the top 100 Companies for Remote Jobs in 2021
The compensation package includes a competitive salary, car allowance, performance-based bonus, IT equipment, possibility of sign-on bonus (for senior candidates) and mileage reimbursement.
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