Onsite Clinical Research Associate - GCP/ICH Expert

Iqvia Uk's Cfsp; England; On-site; GBP 34,000 - 52,000; Full time

Benefits offered by this job

Career development opportunities

Flexible working

Well-being support

Job summary

IQVIA UK's cFSP (sponsor-dedicated) team is growing, seeking experienced Clinical Research Associates to monitor interventional studies in the UK. You will perform site visits, support recruitment strategies, train site staff, and ensure regulatory compliance across TMF/ISF documentation.

We value strong communication, collaboration with study teams, and a minimum of 2 years on-site monitoring experience. The role requires full UK right to work and offers a dynamic, career-forward path with

Qualifications

• Minimum 2 years on-site monitoring experience in interventional studies.
• Good knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Excellent communication and relationship-building with study sites and cross-functional teams.
• Full UK right to work; visa sponsorship not offered.

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 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

Skills

On-site monitoring experience

Regulatory knowledge

Communication skills

Team collaboration

UK right to work

Education

Degree in scientific discipline or health care

Job description

IQVIA UK's cFSP (sponsor-dedicated) team is growing, seeking experienced Clinical Research Associates to monitor interventional studies in the UK. You will perform site visits, support recruitment strategies, train site staff, and ensure regulatory compliance across TMF/ISF documentation.

We value strong communication, collaboration with study teams, and a minimum of 2 years on-site monitoring experience. The role requires full UK right to work and offers a dynamic, career-forward path with