At a Glance
- Tasks: Monitor clinical sites, ensuring compliance and supporting Oncology studies across the UK.
- Company: Join IQVIA, a leader in clinical research and healthcare intelligence.
- Benefits: Gain valuable experience, make a real impact, and enjoy continuous learning opportunities.
- Other info: Flexibility to travel and a commitment to integrity in the hiring process.
- Why this job: Be part of a mission to create a healthier world while advancing your career.
- Qualifications: Experience in Oncology monitoring and knowledge of GCP and ICH guidelines required.
The predicted salary is between 35000 - 45000 £ per year.
IQVIA's Site Management (multi-sponsor) team are seeking a Clinical Research Associate to join us on our mission to help create a healthier world. The Clinical Research Associate will support Oncology studies and cover sites across the UK. Apply today and forge a career with greater purpose, make an impact and never stop learning!
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- 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
- Experience of independent on-site monitoring of Oncology therapeutic area for unblinded studies.
- In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Life science degree educated or equivalent industry experience.
- Flexibility to travel to sites as required.
*Please note - this role is not eligible for visa sponsorship*
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.
Clinical Monitoring Associate in Hampshire employer: IQVIA
At IQVIA, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and continuous learning. As a Clinical Monitoring Associate, you will have the opportunity to make a meaningful impact in the field of Oncology while benefiting from comprehensive training and career development programmes. Our commitment to employee growth, coupled with our mission to improve global health outcomes, makes IQVIA a rewarding place to advance your career.
