CRA2 – Multi-Sponsor Department
IQVIA UK’s Site Management (multi-sponsor) team is growing and seeking junior and experienced Clinical Research Associates.
Apply today and forge a career with greater purpose, make an impact, and never stop learning!
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 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
Requirements
- 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
Please note - this role is not eligible for UK visa sponsorship
About Us
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
Clinical Research Associate II in Manchester employer: Meeveem Limited
Meeveem Limited is an exceptional employer that values its employees by fostering a collaborative and innovative work culture in the heart of Yorkshire. With a strong focus on professional development, employees are encouraged to grow their skills and advance their careers while enjoying competitive benefits and a supportive environment that prioritises work-life balance. Joining Meeveem means being part of a dynamic team dedicated to making a meaningful impact in the cardiovascular and endovascular sectors.
