Clinical Monitoring Associate

IQVIA LLC; England; Sur place; GBP 52 000 - 76 000; Plein temps

Résumé du poste

IQVIA cFSP is seeking experienced Clinical Research Associates in the UK to perform on-site monitoring visits and support trial management. The role requires independent monitoring experience, site training, and strong GCP/ICH knowledge.

Travel to diverse investigative sites is expected as part of the role, with access to IQVIA’s training and development resources to advance your clinical research career.

Qualifications

• 18+ months of independent on-site monitoring
• Experience across multiple clinical trial protocols
• Strong knowledge of GCP and ICH guidelines
• Life science degree or equivalent industry experience
• Willingness and ability to travel to sites as required

Responsabilités

• Perform on-site monitoring visits (selection, initiation, monitoring, close-out) per contract scope and GCP/ICH guidelines.
• Coordinate with sites to drive recruitment plans and track subject enrollment.
• Administer protocol training to sites and maintain regular communication to manage expectations and issues.
• Assess site conduct and data quality, escalate issues as needed.
• Track regulatory submissions, enrollments, CRF completion, data queries, and support start-up activities.
• Maintain TMF/ISF documentation and ensure regulatory filings meet GCP and local requirements.
• Prepare visit reports, follow-up letters, and other study documentation.
• Collaborate with study team members to support project execution.

Connaissances

Independent on-site monitoring

Multi-site trial management

GCP/ICH knowledge

Travel flexibility

Formation

Life science degree

Description du poste

• 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

• A minimum of 18 months 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

IQVIA cFSP (sponsor-dedicated) are seeking experienced Clinical Research Associates in the UK.

With access to world-class training and professional development, we'll give you the tools you need to create the career you want.

Why IQVIA?

IQVIA is recognized as #1 in its category on the 2026 Fortune World's Most Admired Companies list for the fifth 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! 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.

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IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.