CRA2 - Multi-Sponsor Department

Job Title: CRA2 - Multi-Sponsor Department
Job Location: London, Greater London, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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
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.

This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Originally posted on Himalayas