CRA II - RWE

IQVIA LLC; West of England; On-site; GBP 38,000 - 58,000; Full time

Benefits offered by this job

Community

Development

Flexibility

Recognition

Well-being

Job summary

IQVIA LLC is seeking a Clinical Research Associate II to support Phase 3b and Phase 4 studies across the UK & Ireland. The CRA will perform 6–7 site visits per month, ensure GCP/ICH compliance, and collaborate with study teams for successful trial execution.

The role requires 1–2 years of on-site monitoring experience, a degree in a scientific discipline or healthcare, and the ability to manage site communications and regulatory activities. Visa sponsorship is not offered.

Qualifications

• On-site monitoring experience for 1–2 years.
• Good knowledge of GCP/ICH guidelines.
• Degree in scientific discipline or health care.
• Ability to establish effective working relationships with sites.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out).
• Track site recruitment plans to improve predictability.
• Administer protocol training and maintain regular site communication.
• Assess site adherence to the protocol and regulations; escalate issues.
• Manage regulatory submissions, recruitment, CRF completion, data queries.
• Maintain TMF/ISF and related study documentation.
• Collaborate with study team for project execution.
• Support start-up activities as needed.
• Ensure right to work in UK & Ireland; no visa sponsorship.

Skills

On-site monitoring

GCP/ICH knowledge

Site management

Communication with sites

Education

Degree in scientific discipline or health care

Job description

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.

Requires at least 1-2 years of on-site monitoring experience.

Degree in scientific discipline or health care or equivalent industry experience.

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.

Ability to establish and maintain effective working relationships with coworkers and clients.

Please note this position cannot offer visa sponsorship, candidates must hold right to work in UK & Ireland.

Join IQVIA on our mission to accelerate innovation for a healthier world!

IQVIA UK's RWE team is seeking a Clinical Research Associate II to support Phase 3b and Phase 4 studies across a diverse range of therapeutic areas. The CRA will cover sites across UK & Ireland, with 6-7 site visits per month.

Why join IQVIA?

• Community - collaborate with diverse teams and contribute to meaningful work that improves lives.
• Development - access tailored learning and development to grow your skills and advance your career.
• Flexibility - enjoy a supportive environment that helps you balance work and life.
• Recognition - ee celebrated for your contributions and supported in reaching your goals.
• Well-being - benefit from country-specific programs that support your health and happiness., 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.