CRA II - RWE

IQVIA Inc; Dublin; On-site; EUR 48,000 - 72,000; 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 perform site monitoring visits in line with GCP/ICH, manage recruitment plans, training, and ensure TMF/ISF compliance. This role requires 1–2 years on-site monitoring experience and a degree in a scientific discipline or healthcare.

Qualifications

• 1–2 years on-site monitoring experience.
• Degree in scientific discipline or health care or equivalent.
• Good knowledge of GCP and ICH guidelines.
• Ability to establish and maintain effective working relationships with coworkers and clients.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in accordance with GCP/ICH and contract scope.
• Drive and track subject recruitment plans to support project needs.
• Administer protocol training to sites and maintain regular communication about project expectations and issues.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate quality issues as needed.
• Track regulatory submissions, recruitment, CRF completion, data queries, and support start-up activities.
• Ensure site documents are filed in TMF and ISF maintained per regulatory requirements.
• Create and maintain site management documentation and visit reports; issue follow-up letters as required.
• Collaborate with study team for project execution.

Skills

Site monitoring

GCP/ICH knowledge

Communication

Relationship building

Education

Science/Healthcare degree

Job description

Reading, Berkshire, United Kingdom

Dublin, Ireland

Bath, United Kingdom

Manchester, United Kingdom

Livingston, West Lothian, United Kingdom

Full time

R1577400

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.

Responsibilities

• 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.

Requirements

• 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.

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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