CRA II - RWE

IQVIA LLC; Sefton; On-site; GBP 32,000 - 48,000; Full time

Job summary

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.

You will monitor sites to ensure protocol compliance, manage regulatory submissions, and maintain TMF/ISF, reporting findings and maintaining strong site communications.

Qualifications

• 1–2 years on-site monitoring experience.
• Degree in scientific discipline or health care or equivalent.
• GCP and ICH guidelines knowledge.

Responsibilities

• Perform site monitoring visits per contracted scope and regulations.
• Drive subject recruitment plans to support project needs.
• Administer protocol training to sites and maintain communication.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Track regulatory submissions, enrollment, CRF completion, and data queries.
• Maintain TMF/ISF and ensure filing in accordance with regulations.
• Document site management, visit findings, and action plans.
• Collaborate with study team for project execution support.
• Minimum 1–2 years of on-site monitoring experience required.
• Can support start-up phase where needed.
• Note: visa sponsorship cannot be offered; right to work in UK & Ireland required.

Skills

On-site monitoring

GCP knowledge

ICH guidelines

Regulatory submissions

Data query resolution

Documentation

Communication

Education

Degree in scientific discipline or health care

Tools

TMF management

ISF maintenance

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.