Clinical Research Associate (CRA2) - Multi-Sponsor Department
iqvia · Manchester
Job description
About the role
IQVIA UK's Site Management (multi-sponsor) team is growing and is looking for both junior and experienced Clinical Research Associates. The role covers site monitoring visits and the day-to-day management of assigned studies, working with sites to meet project needs.
Key responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close-out) according to the contracted scope of work and regulatory requirements such as GCP and ICH guidelines.
- Work with sites to adapt, drive and track the subject recruitment plan so it matches project needs.
- Deliver protocol and study training to assigned sites and keep regular contact to manage ongoing expectations and issues.
- Evaluate the quality and integrity of site practices, escalate quality issues as appropriate and manage study progress through regulatory submissions, recruitment, CRF completion and data queries.
- Support the start-up phase where required, ensure site documents are available for the Trial Master File and that the Investigator's Site File is kept in line with GCP and local regulations.
- Create and maintain documentation on site management and monitoring visits, including visit reports, follow-up letters and other study documents.
- Liaise with study team members to support project execution.
Required profile
- Experience of independent on-site monitoring and having managed multiple clinical trial protocols across diverse sites.
- Life science degree or equivalent industry experience.
- Flexibility to travel to sites.
- The role is not eligible for UK visa sponsorship.
Required skills
- In-depth knowledge of Good Clinical Practice (GCP) and ICH guidelines.
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Published 7 hours ago
Expires 1 month from now
4 views · 0 interested
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iqvia
Manchester