September 5, 2024

Oxford Global Resources

Wavre

FULL TIME

Clinical Research Associate (DU/FR/EN)

For one of our clients, a pharma company located in Wavre, we are looking for an experienced CRA to come on board and join the team. This rols is open to candidates with a previous experience in clinical research on the sponsor side, ideally as a CRA.

Job Description

As an experienced CRA, you will join our client's Real World Evidence team and will work on observational studies.

Responsibilities

Manage and prepare clinical study submissions to ethics committees together with CTA (Clinical Trial Assistant) and CPM (Clinical Project Manager)
Follow-up of Clinical Study Agreements (CSA) until its fully execution together with CTA and CPM
Prepare site files in collaboration with CTA
Conduct on site initiation and close-out visits with investigators and other related research personnel (e.g. research nurses) for the studies assigned.
During the study, follow-up with sites regarding inclusion, data entry, queries, data cleaning,…
Be the site's point of contact to answer study specific questions/resolve site issues.
Update internal KPI systems up to date for the assigned studies (event dates - site information - site reports)
Collecting, QC and filing of essential documents as defined per the company's SOPs for NIS
Budget / Payment tracking and execution of payments to Investigational sites staff as defined in the CSA (in collaboration with CTA)
Track and report site/study status to ARWEL/CPM.
Manage translation and tracking of translations for appropriate study documents if applicable.
Attend relevant internal and external training courses as determined by the line manager.

Requirements

Health related diploma (bachelor or master's degree)
Previous experience in clinical research on the sponsor side is mandatory, ideally as a CRA.
Ideally, trilingual DU/FR/EN or bilingual NL/EN or FR/EN with a good level in the other national
Proactive, problem-solver
Existing right to work in Europe is required

Benefits

A balanced salary package based on your skills and experience
Hybrid working policy : 3 days/week in the office and 2 days/week of homeworking
Permanent contract