The Netherlands, Leiden
€45,000-60,000 annual salary
This is an office or home based role.
This Leading Global CRO has an extremely strong position in the market with $180million of product in the pipeline/market and is going to double in size in the next couple of years, so it is full of great prospects for opportunity to expand and grow. With high annual revenues, this company reinvests back into itself with the aim to provide more of and a higher standard of training for all employees as well investing into improving the general quality of life amongst the company meaning the successful candidate will live a healthy and wealthy lifestyle during their time there. As well as this, they have invested in specialist companies including two specialist CRO’s, one of which specialises in Oncology and one of which operates solely in the Asia Pacific Region, giving them an Oncology arm and true global footprint which has allowed them to compete in bid defence meetings for $20-30million trials and of course win. Within this company, there will always be plenty of opportunity to grow as a professional and will always provide the choice of travelling and relocating.
This company is looking for a career driven Clinical Research Associate ll Oncology lll with three years of direct experience in managing all aspects of international studies to completion management of national multi-centre studies. The successful candidate has the choice of being based either at home or in the office and will be outsourced directly to the sponsor with the aim to seriously progress within a successful team of 2200 professionals across the world.
Primary Key Responsibilities:
As a CRA, you will be responsible for all aspects of study site monitoring. This includes routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.
• Site administrating and site monitoring responsibility for clinical studies according to Standard Operating Procedures, ICH Guidelines and GCP.
• Recruiting potential investigators, working with start-up department for EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by the supervisor.
• Completing Serious Adverse Event (SAE) reporting, and processing production of reports.
• Negotiating study budgets with potential investigators and assisting the legal department with statements of agreements as assigned.
Required skills, experience:
• Understanding of the clinical trial process.
• Minimum two years of monitoring experience in pharmaceutical or CRO industries.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
• Thorough knowledge of monitoring procedures.
• University Degree in life science or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology);
• Fluency in Dutch and English language.
What we offer YOU
Having successfully taken on this elite opportunity, you will be:
• Rewarded with this unique and exotic opportunity to develop you career
• Directly outsourced to the sponsor
• Accustomed to exceptional training
• Given an exceptional remuneration package
• Rewarded with an extremely competitive salary
This position is expected to be filled exceptionally quickly due to it being a particularly rare opportunity. Please send your CV to email@example.com to avoid disappointment.
If your CV does not fit the above description, please forward this opportunity to somebody who’s will. In return, we will reward you with £/€500.00 should they be placed by us in a permanent position.