Inhouse Cra

For one of our clients, a medical device company based in Machelen, we are looking for an enthusiastic Inhouse CRA to come on board and join the team to cover sites located in Flanders and in the Netherlands. This position is open for bilingual candidates Dutch and English, with a first experience in clinical research. Job Description The Inhouse Clinical Research Associate (Inhouse CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world class shared clinical technology, process innovation and clinical operations team, in partnership with the company's divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection. Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the Inhouse CRA conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures. Partner with clinical sites to support the negotiation and customization of Informed Consent Form (ICF) Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies. Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking. Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals. Update and maintain study-specific startup and close out trackers. Review and upload documents in applicable database Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc. Participates in study-specific meetings, teleconferences, and trainings. Collaborates with cross-functional team members and study sites throughout all study phases. Support internal quality audits, regulatory inspections, as applicable. Experience in study submission to the Ethics Committee (Netherlands and Belgium) is a strong asset. Bilingual Dutch/English. Being trilingual Dutch/English/French is an asset. Ability to work in a team environment and possess clear, concise communication & presentation skills - written and verbal. Benefits Fulltime position A balanced salary package based on your capabilities and experience, including extra legal benefits Hybrid working :
2-3 days/week home-based.