CRA based in the Netherlands / Sponsor dedicated
Join Covance as a CRA and be dedicated to one of our main client based in Amsterdam. You would be joining the teams of ou Sponsor, an international pharmaceutical company known for being one of the main innovator in drug development (oncology, cardioloy, endocrinology, rare disease...).
Be part of a dynamic team and join a work environment offering flexibility, career development perspective and energizing purpose!
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation
Prepare accurate and timely trip reports
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Assist with training, of new employees, e.g. co-monitoring
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
Education / Qualifications:
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
Extensive Clinical Monitoring experience within a CRO or pharma environment
Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
Good planning, organization and problem solving abilities
Ability to work with minimal supervision
Good communication and interpersonal skills
Good analytical and negotiation skills
Fluent in Dutch and in English, both written and verbal
If you are looking to broaden your therapeutic expertise whilst gaining exposure to a Pharmaceutical working environment this is a fantastic opportunity to seize now!
Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE.
We are looking forward to hearing from you and welcoming you to Covance!