Clinical Research Associate II

IQVIA
Berkshire
4 months ago
Applications closed

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Join Us on Our Mission to Drive Healthcare Forward

As a Clinical Research Associate at IQVIA, you’ll play a vital role in advancing clinical research and improving patient outcomes. We’re expanding our Site Management team and looking for passionate CRAs who are ready to make a difference. This role offers a mix of on-site and remote monitoring, supporting work-life balance while contributing to cutting-edge clinical trials.

Why IQVIA?

IQVIA is recognized as #1 in its category on the 2025 Fortune® World’s Most Admired Companies™ list for the FOURTH consecutive year! We offer genuine career development opportunities for those who want to grow as part of the organization. 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. Next generation clinical development!

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

Profile

Over 2 years of independent on-site monitoring experience, ensuring compliance with GCP, protocol requirements, and regulatory guidelines. You have successfully managed multiple clinical trial protocols across diverse investigative sites. Hands-on experience in the Oncology therapeutic area. Flexibility and commitment to nationwide travel

** This role is not eligible for UK Visa Sponsorship**

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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

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