Bordet - Clinical Research Associate (m/f/x) - Permanent contract- 38h/week

La société

The Brussels University Hospital (H.U.B.) brings together the Erasme Hospital, the Jules Bordet Institute, and the Queen Fabiola University Children's Hospital (HUDERF). Created in 2021 at the initiative of the City of Brussels and the Université Libre de Bruxelles (ULB), this major university hospital group guarantees both high-quality, accessible healthcare for all and excellence in training and research.

The H.U.B has 1,420 hospital beds and more than 6,000 staff members, including 841 FTE physicians and 3,975 FTE non-medical personnel. The H.U.B aims to provide all its teams with a fulfilling and attractive working environment, offering opportunities for training and career development, while ensuring sustainability and thus the financial viability of the institution as a whole.

Department description

The Clinical Trials Center (CTC) at the Jules Bordet Institute is a leading facility dedicated to the coordination, implementation, and management of clinical research studies in oncology. As an integral part of a comprehensive cancer center recognized internationally for its excellence in care, research, and innovation, the CTC plays a vital role in advancing new diagnostic and therapeutic approaches.

Our multidisciplinary team works in close collaboration with medical and scientific staff to support academic and industry-sponsored clinical trials, from early-phase studies to large-scale international trials. The Center ensures that all studies are conducted in compliance with the highest standards of Good Clinical Practice (GCP), ethics, and patient safety.

With state-of-the-art infrastructure and a patient-centered approach, the Clinical Trials Center actively contributes to the mission of the Jules Bordet Institute: to offer every patient access to the most innovative treatments and to contribute to the development of tomorrow's medicine.

Fonction

Position

The Clinical Research Associate oversees the investigational sites to ensure that:

• rights and well-being of subjects are protected
• reported trial data are accurate, complete and verifiable from source documents
• conduct of the trial is compliant with current protocol, with GCP and applicable regulatory requirement and guidelines

Within the Jules Bordet Institute CTSU, the Clinical Research Associate builds, manages and supports site relationship while serving as liaison between the Sponsor (Institut Jules Bordet) and assigned sites.

Duties and Responsibilities:

• Conduct monitoring visits including site initiation visits, routine monitoring visits and close-out visits. These visits can be performed on-site and/or remotely and according the Monitoring Plan;
• Serve as primary contact for assigned sites;
• Verify that the investigator, site staff and site facilities and supplies remain adequate throughout the trial course;
• Maintain working knowledge of the protocol, trial guidelines, sponsor’s procedures, ICH-GCP and Monitoring Plan for assigned studies;
• Collect and ensure adequate completeness of all essential regulatory documentation from the sites during the complete trial period (initiation till close-out visit);
• Ensure timely resolution of the issues observed and data queries;
• Perform investigational medication accountability for the assigned sites;
• Write monitoring reports and follow-up letters within defined timelines;
• Communicate protocol deviations and any other issues observed to the site investigator and to the Lead CRA and takes actions to prevent recurrence;
• Manage and motivate sites to meet the study goals;
• Demonstrate flexibility and adaptability;
• Work according to the study specific timelines and budget agreement;
• Proactively identify, manage, escalate when needed to the Lead CRA and resolve site issues effectively and independently according the issues observed;
• Participate in team teleconferences/meetings/training.

Profil

What We’re Looking For

> Someone who:

• Holds a degree in Paramedical or Life Sciences

• Has experience in clinical monitoring and/or in the oncology therapeutic area (a strong asset)

• Understands the clinical research process and medical terminology (a plus)

• Speaks French or Dutch fluently (native level)

• Communicates clearly and effectively in English, both written and spoken

• Builds strong interpersonal relationships and communicates with confidence

• Enjoys collaborating with others but also works well independently

• Stays calm under pressure and thrives in a dynamic environment

• Manages multiple tasks efficiently and meets tight deadlines

• Is highly organized, detail-oriented, and solution-focused

• Thinks logically and has a naturally curious mindset

• Is proficient with Microsoft Office tools

• Has excellent knowledge of ICH-GCP guidelines

• Has a personal vehicle (a plus)

• Is open and available for domestic and international travel as needed

Langue

You have a good knowledge of the second national language or are willing to acquire it (language courses are organized internally during working hours, with the possibility of receiving a SELOR bilingualism bonus of €150 gross, subject to the submission of the SELOR Art. 10 certificate).

Offre

• A full-time permanent contract (38h/week)
• Extra-legal benefits include:

  • Meal vouchers worth €7.30

  • Preferential rates for medical care in all hospitals within the network (for you, your spouse, your dependent ascendants or descendants)

  • 100% reimbursement of the annual STIB subscription, 80% reimbursement of public transport costs and/or bicycle allowance

  • An annual attractiveness bonus

  • A monthly bilingualism allowance of €150 gross (subject to presentation of the Selor Art. 10 certificate)

  • 29 leave days

  • A personalized onboarding program to support you in your new role

  • A training program that will allow you to grow throughout your career

Application Process
Interested? Send your CV along with a cover letter via our website.