Institut Jules Bordet - Assistant(e) administratif/ve à l’Implémentation des études en Recherche Clinique (Start Up Specialist Assistant) Temps plein Clinical Trials Conduct Unit (CTCU)

Détails de la société

L’Hôpital Universitaire de Bruxelles (H.U.B.) regroupe l’Hôpital Erasme, l’Institut Jules Bordet et l’Hôpital Universitaire des Enfants Reine Fabiola (HUDERF). Créé en 2021 à l’initiative de la Ville de Bruxelles et de l’Université Libre de Bruxelles (ULB), ce grand pôle hospitalier universitaire garantit à la fois des soins de santé de haute qualité et accessibles à tous ainsi que l’excellence dans la formation et la recherche. Le HUB compte 1.420 lits d’hospitalisation et plus de 6.000 membres du personnel, dont 841 ETP médecins et 3.975 ETP non médicaux. Le HUB a pour ambition d’offrir à l’ensemble de ses équipes un cadre de travail épanouissant et attractif, avec des possibilités de formation et d’évolution professionnelle, tout en garantissant la pérennité et donc la viabilité financière de l’ensemble.

L’Institut Jules Bordet est un hôpital public à vocation académique, monospécialisé dans la prise en charge de patients adultes atteints de cancer. Il est le seul centre intégré autonome de lutte contre le cancer reconnu en Belgique et poursuit une triple mission de soins, d’enseignement et de recherche. L’Institut Bordet fait partie de l’Hôpital Universitaire de Bruxelles, qui regroupe également l’Hôpital Erasme et l’Hôpital Universitaire des Enfants Reine Fabiola.

Fonction

The Clinical Trials Support Unit (CTSU) is a department of the Institut Jules Bordet. The Institut Jules Bordet is an integrated multi-disciplinary centre, unique in Belgium and with an international reputation. The hospital is an academic non-profit organisation devoted entirely to patients affected by cancer.

The whole CTSU team fight cancer through the design, set-up and conduct of innovative clinical studies that matters for patients.

With an experience of more than 20 years, we propose a wide range of services in clinical study management, from scientific support to operational activities. We promote an academic research while encouraging collaboration with other academic partners and pharmaceutical companies.

Within the project management team, the IJB CTSU is seeking motivated Clinical Trial Assistants.

Position

The Clinical Trial Assistant (CTA) supports the study team and completes the tasks required to enable the team to achieve the deliverables in the prescribed study timelines all throughout the clinical trial process. The CTA administers and maintains various logistical aspects of clinical trials in accordance with standard procedures and guidelines. The CTA is playing a key role to ensure transversal approach within the project management team by working on multiples studies with different Project Managers (PM).

A CTA who gained experience can evolve towards the position of Project Manager.

Duties and Responsibilities:

• Organise study set-up activities in close collaboration with the PMs
• Contribute to the preparation of study protocol and informed consent forms and write any other clinical research related documents
• Assist with Ethics Committees and/or Competent Authorities submissions and filing necessary supportive documentation
• Assist with the sites selection (writing and collection of feasibility questionnaires, essential documents collection, …)
• Track site contracts approvals, invoices and payments (sites, vendors, grant providers, …)
• Participate in the coordination of Investigational Medicinal Product (IMP) supplies
• Ensure studies are carried out according to the study protocol, SOPs, and ICH GCP regulations and study specific manuals and procedures
• Report risks/issues that can affect the study and work to the study team to implement corrective actions
• Ensure appropriate filing of study documents in the trial master file
• Organise meetings (dates, agenda, minutes, ...)
• Organise study close down activities in close collaboration with other PMs
• Support the department in the development of documentation and process improvement

The Clinical Trial Assistant reports to the Head of CTSU Operations.

Profil

Profile

• Holds a degree in the paramedical, biomedical or scientific field
• Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials
• At least 2 years of experience in the Clinical Research field

Skills and competencies

• English proficiency (written and oral), as well as French and/or Dutch
• Advanced Microsoft Office skills
• Ability to prioritize multiple and varied tasks efficiently and accurately
• Attention to detail and strong organizational skills
• Advanced writing skills including ability to summarize information
• Ability to work as a team member or independently with minimal supervision
• Self-starter with strong problem-solving skills
• Excellent interpersonal, verbal and written communication skills and strong diplomatic skills
• Flexible attitude with respect to work assignments and new learning
• Ability to handle confidential information

Offre

• Full time position
• 6 months fixed-term contract, renewable under a long-term contract
• Start date as soon as possible

For more information on the available position and environment, please follow the link https://ctsu.bordet.be