CRA 2 - Single Sponsor Dedicated

IQVIA; Livingston; On-site; GBP 35,000 - 52,000; Full time

Job summary

IQVIA in the United Kingdom is seeking experienced Clinical Research Associates to monitor and manage sites, ensuring studies comply with the protocol, regulations, and sponsor requirements. You will perform site visits, support recruitment plans, and maintain study documentation across multiple trials.

The role requires on-site monitoring experience, strong knowledge of GCP/ICH guidelines, and excellent communication, time management, and collaboration skills.

Qualifications

• On-site monitoring experience required or equivalent.
• Knowledge of GCP/ICH guidelines.
• Strong written and verbal English communication.
• Good organizational and problem-solving skills.
• Ability to manage time and finances effectively.
• Ability to collaborate with study teams and clients.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in line with scope of work and Good Clinical Practice.
• Work with sites to drive subject recruitment plans to meet project needs.
• Administer protocol and study training to sites and maintain regular communication.
• Evaluate site practices for protocol compliance and regulatory adherence; escalate issues.
• Track regulatory submissions, recruitment, CRFs, data queries, and study progress; support start-up as needed.
• Maintain TMF and ISF documentation; ensure site documents are filed.
• Collaborate with study team members for project execution support.

Skills

On-site monitoring

GCP/ICH knowledge

English communication

Time management

Team collaboration

Education

Bachelor's degree in science/healthcare

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Laptop/Apple devices

Job description

Join Us on Our Mission to Drive Healthcare Forward

IQVIA cFSP (sponsor-dedicated) are seeking experienced Clinical Research Associates in the UK.

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• 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.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 1 of 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.
• i.e., 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 use of 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 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 https://jobs.iqvia.com

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.