CRA II - RWE

IQVIA LLC; United Kingdom; Sur place; GBP 38 000 - 58 000; Plein temps

Avantages offerts par ce poste

Community

Development

Flexibility

Recognition

Well-being

Résumé du poste

IQVIA UK’s RWE team is seeking a Clinical Research Associate II to support Phase 3b and Phase 4 studies across therapy areas in the UK & Ireland. The CRA will perform site monitoring visits and work with sites to support recruitment planning, protocol training and study documentation.

A 1–2 year on-site monitoring background and strong knowledge of GCP/ICH are essential. Travel involves 6-7 site visits per month across the region, with collaboration across study teams to ensure quality and

Qualifications

• 1-2 years of on-site monitoring experience required.
• Good knowledge of GCP and ICH guidelines.
• Ability to establish and maintain effective working relationships with coworkers and clients.

Responsabilités

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and regulatory requirements.
• Drive and track subject recruitment to meet project needs.
• Administer protocol and study training to sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate issues.

Connaissances

Site monitoring

Regulatory knowledge

Communication skills

Project coordination

Formation

Degree in scientific discipline or health care or equivalent experience

Description du poste

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.

• 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.

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