Clinical Research Associate Ii

2 weeks ago

Reading, United Kingdom IQVIA Full time

Join IQVIA on Our Mission to Drive Healthcare Forward

IQVIA's Real World Evidence team are seeking a Clinical Research Associate II. The position is UK based and offers remote working with travel to sites across the UK and Ireland.

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.

**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
- 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

**Requirements**:

- Experience of independent on-site monitoring.
- You have successfully managed multiple clinical trial protocols across diverse investigative sites.
- In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Life science degree educated or equivalent industry experience
- Flexibility to travel to sites.

LI-ADAMTHOMPSON

*Please note - this role is not eligible for UK visa sponsorship*

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