The CRA 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). He/she 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.
- To act as main point of communication between sponsor, site staff and any third party.
- To ensure that the study is conducted and documented in compliance with the approved protocol/amendment(s), with GCP and with all applicable regulatory requirements.
- To work according to the applicable quality management system (HarmonyCR or client).
- To perform submissions to Ethical Committees and Regulatory Authorities: initial submissions, notifications, 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 perform source data verification in compliance with the requirements as set out in the monitoring manual.
- To monitor the conduct and progress of the study.
- To collect, maintain 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 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 by HarmonyCR.
- To participate on department-wide tasks to contribute to the optimization of processes within the department.
- Any other task that may be requested as far as can reasonably be expected, including those tasks that are linked to the job description of the Clinical Trial Assistant (CTA).
Degree in life science, preferably higher vocational education or academic degree
Preferably at least 1 year experience in (international) clinical research
Fluent in English, Dutch and French; another European language is an asset
Microsoft Office (Outlook, Word, Excel, PowerPoint), internet; any experience with CTMS, eCRF systems is an advantage
Excellent knowledge of ICH-GCP and all applicable regulatory requirements
- Diplomatic and tactful
- Communicative: oral as well as in writing (one-on-one as well as in group)
- Team player
- Problem solver and analytical capabilities
- Accurate and well organized
- Detail oriented
- Working independently
- Stress resistant
- Willingness to travel frequently, also to other countries (mainly The Netherlands)