CRA2 - Multi-Sponsor Department

IQVIA LLC; Broughton; On-site; GBP 35,000 - 60,000; Full time

Job summary

IQVIA LLC is seeking an on-site Clinical Site Monitor to oversee monitoring visits across sites in line with GCP and ICH guidelines. You will establish active communication with sites, implement recruitment plans, and ensure accurate documentation and regulatory compliance.

The role requires expertise in trial conduct, ability to travel, and collaboration with cross-functional teams to ensure smooth study execution and data integrity.

Qualifications

• Life science degree or equivalent industry experience.
• GCP and ICH guidelines knowledge and practical application.
• Ability to travel to clinical sites and work across regions.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) per GCP/ICH.
• Collaborate with sites to drive and track subject recruitment plans.
• Deliver protocol training and maintain regular site communication.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate issues.
• Track regulatory submissions, recruitment, CRF completion, data queries; support start-up phase.
• Maintain Trial Master File and Investigator Site File in compliance with GCP/regulations.
• Prepare visit reports, follow-up letters and site documentation.
• Coordinate with study team for project execution and issue resolution.
• Demonstrate independence in monitoring across multiple protocols and sites.
• Travel to sites as required to support study activities.

Skills

On-site monitoring

Travel flexibility

Regulatory communications

Education

Life science degree

Job description

• 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
• 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

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.