CRA - Single Sponsor Dedicated

Overview

Join Us on Our Mission to Drive Healthcare Forward IQVIA cFSP (sponsor-dedicated) are seeking experienced Clinical Research Associates in the UK.

• Perform monitoring visits (selection, initiation, monitoring and close-out) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plans 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, CRF completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies of 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 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 with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plans on a per-site basis.
• If applicable, may be accountable for site financial management according to the executed clinical trial agreement and retrieve invoices according to local requirements.

• Bachelor’s Degree in a scientific discipline or health care preferred. Req
• At least 1 year of on-site monitoring experience. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
• Good knowledge of and skill in applying applicable clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of the English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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.