Company details

At the Institut Jules Bordet, a comprehensive cancer centre, research is realized both at a clinical level and in translational laboratories. It is a highly organized activity mobilizing and involving numerous health professionals, as well as patients. Institut Jules Bordet is very active in developing its own academic research projects and seeks to increase its capacity to finance them.

Function

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;

Profile

• Paramedical or Life Sciences degree
• Clinical monitoring experience and/or other experience in oncology therapeutic area is an asset
• Knowledge of clinical research process and medical terminology is an asset
• French or Dutch native speaker
• Strong written and verbal communication skills in English
• Strong interpersonal skills
• Good communication, negotiation, and people skills
• Good problem-solving skills
• Stress resistant
• Ability to handle multiple tasks to meet deadlines in a dynamic environment
• Strong planning and organizational skills
• Able to work independently and in a team
• A keen attention to detail
• A logical and inquisitive mind
• Be familiar with Microsoft Office
• Excellent knowledge of ICH-GCP
• Able to use his/her personal car is an asset
• Willingness and ability to travel domestically and internationally as required

Offer

• A full time permanent contract
• An attractive salary with extra-legal advantages
• Proximity with a metro station, free parking.

Interested?

Send you CV and letter of application via our website.