Description
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.
Responsibilities
- Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive, and track subject recruitment plans 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.
- 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.
- Ensure copies/originals of 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 documentation regarding site management, monitoring visit findings, and action plans.
- Collaborate and liaise with study team members for project execution support as needed.
Requirements
- At least 1-2 years of on-site monitoring experience.
- Degree in a scientific discipline or healthcare, or equivalent industry experience.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, such as GCP and ICH guidelines.
- Ability to establish and maintain effective working relationships with coworkers and clients.
Benefits
- 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: be celebrated for your contributions and supported in reaching your goals.
- Well-being: benefit from country-specific programs that support your health and happiness.