Overview
In this role you support the execution of interventional studies as a Clinical Research Associate within IQVIA’s sponsor-dedicated team. You will conduct on-site monitoring and ensure compliance with GCP/ICH while collaborating with sites to optimize recruitment and study conduct. You translate regulatory requirements into practical site management and maintain TMF/ISF documentation. The position offers growth within a global health-focused organization and opportunities to work with cross-functional teams on high-impact trials. You will contribute to delivering high-quality data and patient outcomes in a fast-paced environment.
Pay / Benefits
- Flexible working
- Well-being support
- Career development opportunities
- Mentorship opportunities
- Internal talent marketplace (Career Connections)
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with scope and GCP/ICH guidelines
- Collaborate with sites to drive recruitment to meet project needs
- Administer protocol training and maintain regular communication with sites
- Evaluate site practices for protocol conduct and regulatory compliance, escalating quality issues
- Track regulatory submissions, recruitment, CRF completion, data queries; support start-up as needed
- Maintain TMF/ISF documentation and ensure file readiness
- Create site management documentation, visit reports, and follow-up letters
- Collaborate with study team members for project execution
Key requirements
- At least 6 months independent on-site monitoring experience of interventional studies
- Experience across start-up, enrolment, maintenance, close-out
- Digital literacy with confidence using AI tools in a professional setting
- Degree in scientific discipline / health care or equivalent industry experience
- Knowledge of GCP and ICH guidelines
- Ability to build effective working relationships with coworkers and clients
- Full UK right to work (no visa sponsorship)
- strong communication and interpersonal skills
- ability to collaborate with cross-functional teams
- problem-solving and proactive issue escalation
- GCP and ICH regulatory knowledge
- on-site monitoring and trial management
- documentation and TMF/ISF upkeep
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