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Monitor (Clinical Research Associate-CRA)

Institut Jules Bordet

Full time |  Permanent  |  Fresher  |  Salary type not mentioned Salary not mentioned  |  1 Jobs

Job Description

Job duties and responsibilities

The monitor:

conducts monitoring visits including site initiation visit, routine monitoring visits and close-out visits. These visits can be performed on-site and/or remotely and according the Monitoring Plan;
serves as primary contact for assigned sites;
verifies that the investigator, site staff and site facilities and supplies remain adequate throughout the trial course;
maintains working knowledge of the protocol, trial guidelines, sponsor’s procedures, ICH-GCP and Monitoring Plan for assigned studies;
collects and ensures adequate completeness of all essential regulatory documentation from the site during the complete trial period (initiation till close-out visit);
ensures timely resolution of the issues observed and data queries;
performs investigational medication accountability for the assigned sites;
writes monitoring reports and follow-up letters within defined timelines;
communicates protocol deviations and any other issues observed to the site investigator and to the Sponsor Monitoring Manager and takes actions to prevent recurrence;
manages and motivates sites to meet the study goals;
demonstrates flexibility and adaptability;
works according to the study specific timelines and budget agreement;
proactively identifies, manages, escalates when needed to the Monitoring Manager and resolves site issues effectively and independently according the issues observed;
participates in team teleconferences/meetings/training;
participates in site audits, as requested.
Job requirements:

Profile:

Paramedical or scientific degree
Clinical monitoring experience and/or other experience in oncology therapeutic area is an asset
Strong knowledge of clinical research process and medical terminology is an asset
Skills/competencies

French or Dutch speaker
Fluent in the other national language (French or Dutch)
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
Capacities

able to use his/her personal car is an asset
willingness and ability to travel domestically and internationally as required
We offer

A full-time position with an open-ended contract
An opportunity to gain valuable experience in a dynamic academic environment
Opportunities for on-going professional development
CV and motivation letter must be sent (reference: Rech/Mon/2016-04) by e-mail to gestion.oncomed@bordet.be

For more information on the available position and environment, please visit www.bordet.be.
 
 

Role

The monitor 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 IJB Clinical Trials Support Unit (CTSU), the monitor builds, manages and supports site relationship while serving as liaison between the Sponsor (Institut Jules Bordet) and assigned sites.

Contact details

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