Clinical Research Associate - Reading, Berkshire, United Kingdom - IQVIA Argentina

Description

Our Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forward
The chance to work on cutting edge medicines at the forefront of new medicines development
IQVIA has access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. We offer genuine career development opportunities for those who want to grow as part of the organization
We can offer flexibility regarding site locations to minimize travel.

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e.

, 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.

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
You should be life science degree educated
You have experience of independent on-site monitoring experience
Flexibility and ability to travel
Best AI-based Solution for Healthcare" Award in 2023 Artificial Intelligence Breakthrough Awards
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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.