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
