Our Sponsor Dedicated (cFSP) team is growing and we are looking for aspiring CRAs of all levels to join us on our mission to drive healthcare forward!
What We Offer
* The chance to work on cutting-edge medicines at the forefront of new medicine development.
* IQVIA has access to significant data pools allowing better site selection and recruitment, driving performance of sites and making the CRA role more efficient.
* Genuine career development opportunities for those who want to grow as part of the organization.
* Investment in keeping our teams stable, ensuring consistent workload.
* As a CRA, you will receive an iPad and use key developments such as site visit apps that allow CRAs to perform their duties more efficiently.
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 plans 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) of 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 the development of project subject recruitment plans on a per-site basis.
* If applicable, may be accountable for site financial management according to executed clinical trial agreements and retrieve invoices according to local requirements.
Requirements
* Life science degree educated.
* Experience of independent on-site monitoring.
* Experience handling multiple protocols and sites across a variety of drug indications.
* Flexibility and ability to travel.
* Strong communication, written, and presentation skills.
This role is not eligible for UK visa sponsorship.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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