Join us in our exciting journey!! We currently looking for experienced Clinical Research Associates to join our rapidly growing Site Management division team in Belgium.
As an experienced Clinical Research Associate, you could be looking to broaden your therapeutic, geographic or study exposure. Or perhaps you are looking a future beyond monitoring with our development opportunities. At IQVIA, you’ll have training and development to plan and progress your career in the direction you choose; we do not believe in a ‘career ceiling.’
This role is working in our core Clinical Site Management function. The team works with multiple sponsors across a multitude of therapy areas and phases, giving you the opportunity to improve and develop your experience. With strategic site relationship managers supporting you throughout your role, this is a fantastic opportunity for you to embed yourself in the wider clinical operations team and work on ground-breaking new medicine development. Our clients are pharmaceutical companies who are dedicated and passionate about improving the lives of patients across several therapeutic areas.
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
• 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.
• Master's Degree in scientific or healthcare discipline.
• Requires at least 2 year of on-site monitoring experience.
• Good knowledge and skilled in the implementation of applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English, Dutch and French language