Clinical Monitoring Associate

IQVIA LLC; Folly Gate; In loco; GBP 42.000 - 62.000; Tempo pieno

Descrizione del lavoro

IQVIA LLC is seeking a site monitor to perform on-site visits across interventional studies, ensuring adherence to GCP/ICH guidelines. You will drive subject recruitment plans and administer protocol training to sites, maintaining clear communication on project expectations.

The role supports TMF/ISF maintenance and CSF data handling, with ongoing collaboration across the study team. The ideal candidate has 2+ years of independent on-site monitoring experience, knowledge of regulatory

Competenze

• Requires at least 2 years independent on-site monitoring experience of interventional studies.
• Experience across start-up, enrolment, maintenance, close-out.
• Digital literacy, including confidence using AI tools in a professional setting.
• Good knowledge of GCP and ICH guidelines.
• Ability to establish and maintain effective working relationships with coworkers and clients.
• Full UK right to work; visa sponsorship not available.

Mansioni

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with contract scope and GCP/ICH guidelines.
• Collaborate with sites to adapt and track subject recruitment plans to enhance predictability.
• Administer protocol training to sites and maintain regular communication on project expectations.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate issues when needed.
• Track regulatory submissions, recruitment, CRF completion, data queries; may support start-up.
• Maintain TMF filing and ISF in compliance with GCP and local regs.
• Document site management, visit findings, and action plans; circulate reports and follow-ups.
• Collaborate with study team for project execution support.

Conoscenze

Site monitoring

GCP/ICH knowledge

AI tools literacy

Relationship building

Communication

Formazione

Degree in science/healthcare or equivalent

Descrizione del lavoro

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

Requirements

• Requires at least 2 years independent on-site monitoring experience of interventional studies
• Experience across start-up, enrolment, maintenance, close-out
• Digital literacy, including confidence using AI tools in a professional setting
• Degree in scientific discipline / 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

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

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.