You have a scientific background, a first experience in clinical research and you are trilingual Dutch-French-English ? The Clinical Research Associate job appeals to you due to the social interactions, the variety of the job and the scientific content ? Then you may be the candidate our big pharma client is looking for. Check out this opportunity and apply today !
Job Description
The Clinical Research Associate performs activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV clinical trials within the country. The CRA is also responsible to deliver data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and Client SOPs.
Responsibilities
- The Clinical Research Associate conducts site selection to evaluate sites' capabilities for participating in a clinical trial.
- The Clinical Research Associate is the communication link between the company and sites to ensure successful collaboration, meeting the company's expectation on milestone and deliveries
- The Clinical Research Associate performs Site Initiation Visits, ensuring that site personnel is fully trained on all trial related aspects
- The Clinical Research Associate performs continuous training for amendments and new site personnel as required and retrains site stafl as appropriate
- The Clinical Research Associate conducts continuous monitoring activities (both onsite and remote) and implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
- The Clinical Research Associate is accountable for keeping all systems (global and local) up-to-date on an ongoing basis
- The Clinical Research Associate ensures that study milestones for sites are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
- The Clinical Research Associate performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
- The Clinical Research Associate attends onboarding-, disease indication and project specific training and general CRA training as required
- The Clinical Research Associate documents monitoring activities appropriately following company's standards
- The Clinical Research Associate collaborates with the CRA Manager/CPM to ensure recruitment plans and execute contingency plans, as needed
- The Clinical Research Associate participates from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
- The Clinical Research Associate ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the pre-defined goals
Requirements
- Education: Degree in scientific or healthcare discipline
- Languages: you are trilingual (Dutch, English & French)
- You have up to 2 years pharmaceutical industry experience or other relevant experience
- You have a good knowledge of drug development process specifically clinical trial/research, monitoring experience is desirable
- You have knowledge of international standards (GCP/ICH, FDA, EMEA)
- You are willing to to travel domestically (and possibly internationally) as needed to study sites and for training and meetings
- You are an excellent communicator and presenter (oral and written), ability to communicate to Sr. Leaders
- You have the ability to manage sites independently; you have proven ability to work independently with minimal supervision
- You have the ability to anticipate potential issues and take appropriate actions with or without supervision
- You work focused with a great attention to detail
- Existing right to work in Europe required
Benefits
- A full time position with a permanent contract
- A balanced salary package based on your experience and fringe benefits (company car, fuel card, insurances, 12 ADV, ...)
- A challenging environment where a good work-life balance is very important value
Vacancy number: 18433
