CRA - Permanent - 3-5 years' experience
1 day left
- Experience Level
- Experienced (non-manager)
Upsilon Global have partnered with a forward thinking, growing Belgian CRO who are currently seeking to add a permanent CRA with 3-5 years of experience to their dynamic clinical operations team. It is a predominantly homebased position, but post COVID there will be a requirement for 1 day per week in the Ghent office, so it is essential you live within a reasonable distance of Ghent. Functionally, you will report to either an in-house or client based clinical project manager, and your line manager will the CROs clinical operations manager.
As a CRA within this small CRO you will oversee the progress of a clinical trial, and should ensure that it is conducted, recorded, and reported to a high quality in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). You must verify whether the rights, safety and well-being of the subjects are protected and whether the reported trial data are accurate, complete and credible.
You will act as the main point of communication between sponsor, site staff and any third party. You will ensure that the study is conducted and documented in compliance with the approved protocol/amendment(s), with GCP and with all applicable regulatory requirements, while working according to the applicable quality management system both in-house and external.
- To perform submissions to Ethical Committees and Regulatory Authorities: initial submissions, amendments and safety information amongst other.
- To prepare, conduct and report feasibility studies.
- To prepare, conduct and report site selection, initiation, monitoring and close-out visits.
- To build and maintain good collaboration with investigators and site personnel.
- To ensure that sites are prepared and ready to conduct the study in relation to training, study supplies, medication amongst other.
- To verify source data and CRF on completeness and correctness.
- To monitor the conduct and progress of the study.
- To collect, maintain and archive all required essential documents.
- To verify IP ordering, shipments, storage and accountability.
- To verify whether safety reporting requirements are met: SAE, SUSAR, line listings.
- To perform source data verification in compliance with the requirements as set out in the monitoring manual.
- To report adequately and timely to the appropriate person on the progress of the trial and on any item requiring follow-up.
- To coordinate communication between site staff and any other party.
- To participate in international study teams.
- To work, when possible, in a pro-active /anticipating manner to avoid problems from occurring.
- To work in accordance with the specified quality system for the study and to adhere to the study timelines.
- To coordinate audit and inspection preparation activities when required and ensure that corrective and preventive actions are implemented.
- Maintain personnel dossier (training records and CV) up to date as required.
- Any other task that may be requested as far as can reasonably be expected.
- 3-5 years of experience in clinical research as a CRA
- It is essential you are able to monitor confidently and independently
- Previous exposure to Oncology or Vaccines studies would be beneficial, but not essential
- Life Sciences degree is desired, but not essential
- Excellent command of Microsoft Office
- Fluent in English
- Basic level (or higher) of Dutch and French
Please contact Harry on email@example.com or +44 203 875 9966 for further information about this vacancy!
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