Reading, United Kingdom | Full time | Field-based | R1521358
Join IQVIA on our mission to accelerate innovation for a healthier world!
Why IQVIA?
* Career development opportunities to grow as we grow
* AI‑powered career advancement through our internal talent marketplace, Career Connections
* Mentorship opportunities across the organisation via Employee Resource Groups
* Flexible working to assist work–life balance and professional success
* Well‑being support covering your physical, mental, and financial health
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 Investigators 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
* Requires at least 2 years on-site monitoring experience of interventional studies
* Degree in scientific discipline or health care or equivalent industry experience
* 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
* Ability to establish and maintain effective working relationships with coworkers and clients
* Full UK right to work required, this position is not eligible for visa sponsorship
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