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In-house Clinical Research Associate

The In-house CRA will perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Standard Operating Procedures.



Main activities are:

  • Act as the main in-house point of contact for investigators and study coordinators regarding study-related inquiries, fostering collaborative relationships with study sites.

  • Perform remote site management activities in alignment with applicable Standard Operating Procedures (SOPs) and the Study Monitoring Plan.

  • Prepare, collect, process, track, and file study-related documentation, information, and materials in compliance with Good Clinical Practices and relevant SOPs.

  • Utilize and maintain systems such as the Clinical Trial Management System (CTMS) to ensure proper tracking of study progress, upkeep of study documentation, and timely generation of required reports.

  • Review all Adverse Events (AEs) and Serious Adverse Events (SAEs), ensuring proper documentation and communication of any safety issues.

  • Support audit readiness activities by preparing and organizing clinical trial documents.

  • Assist with data validation and data cleaning procedures to meet project timelines.

  • Coordinate and order study supplies for clinical trials.

  • Plan and participate in Investigator meetings and Clinical Research Associate (CRA) trainings.

  • Support the feasibility and site selection process for clinical studies.


Qualifications

  • Preference of more than 1 year of experience in the pharmaceutical / biotechnology / CRO industry monitoring as a Clinical Research Associate from study start-up to database lock.

  • Good knowledge of concepts of clinical research and drug development (GCP, different phases of clinical trials, PI, Sponsor, Site, ...).

  • Strong working knowledge of EDC, IVR and CTMS systems.

  • Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information.

  • Demonstrated strengths in planning, organizational, project management, analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills.

  • Enthusiastic to travel across Belgium and exceptionally abroad.

  • Excellent knowledge of Dutch / French and English

What we offer:

  • We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers , eco vouchers, mobile phone (data included)

  • We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)

  • Side activities will be organised regularly, to achieve a close collaboration within our team

  • We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.

  • We contribute to a number of charities & support the research and / or the patients in our industry.

Interested?




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