Clinical Monitoring Associate

IQVIA LLC; Pill; On-site; GBP 32,000 - 52,000; Full time

Benefits offered by this job

Flexible working

Career development opportunities

Mentorship opportunities

AI-powered career advancement

Well-being support

Job summary

IQVIA UK’s cFSP team is expanding and seeks experienced Clinical Research Associates in the South West England to perform site monitoring visits in line with GCP/ICH guidelines and sponsor requirements. You will coordinate with sites, manage expectations, and support regulatory submissions throughout trials.

Join IQVIA for a mission to accelerate innovation for healthier outcomes, with flexible working, mentorship, and clear career development opportunities offered.

Qualifications

• Minimum 2 years independent on-site monitoring experience of interventional studies.
• Experience across start-up, enrolment, maintenance, close-out.
• Good knowledge of GCP/ICH guidelines and regulatory requirements.

Responsibilities

• Perform site monitoring visits in accordance with contracted scope and regulatory requirements.
• Coordinate site communications to manage project expectations and issues.
• Track regulatory submissions, recruitment, CRF completion, and data queries.
• Ensure ISF and TMF filing are up to date and compliant.
• Collaborate with study team for project execution support.

Skills

GCP/ICH knowledge

On-site monitoring

Digital literacy

Communication skills

Team collaboration

UK work eligibility

Education

Degree in scientific discipline/healthcare

Tools

AI tools familiarity

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

• 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

Join IQVIA on our mission to accelerate innovation for a healthier world!

IQVIA UK's cFSP (sponsor-dedicated) team is growing and seeking experienced Clinical Research Associates in South West England.

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

Brandon Hall Excellence Award for Learning & 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. 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.