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Clinical Research Associate - IQVIA Biotech

IQVIA -
Reading

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Job details

Full-time
13 days ago

Qualifications

Clinical research
Stakeholder liaison
Filing
Recruiting
Clinical compliance monitoring
Good Clinical Practice (GCP)
Good Clinical Practice (ICH-GCP) guidelines
Research participant recruitment coordination
Project progress tracking

Full job description

Reading, United Kingdom | Full time | Field-based | R1521406

At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise, and a biotech tailored delivery model, we accelerate clinical development from early phase through global registrational studies.

Responsibilities

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.

Requirements

Experience of independent on-site monitoring of Oncology therapeutic area for unblinded studies.
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 as required

*Please note - this role is not eligible for 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.

Where you'll work

Field-based

You’ll work where the action is — out in the field, directly engaging with our customers, sites or partners. Field-based roles offer the opportunity to build relationships face-to-face, gain real-world insights and make a tangible impact.

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.

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