Clinical Research Associate Medical Devices
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Netherlands.
Their goal is to change healthcare together and all over the world. They like to push technology to its limit and extend life by restoring health. The employers challenge themselves to make every day better dan the day before to achieve their goals as soon as possible.
ROLE DESCRIPTION
the CRA will assist the duties of study management for assigned clinical programs and department initiatives to evaluate performance, efficacy of products, safety and to satisfy applicable regulatory standards and requirements for regulated studies
RESPONSIBILITIES
• Participate in overall study document development
• Assists in preparation of study and/or department materials and training
• Sets up and maintains accurate clinical study files
• Tracks and maintains study documentation
• Conducts quality check on study documents
• Conducts periodic audits of clinical trial management system to ensure accuracy/consistency of use
• May assist sites with answers to protocol questions, regulations, and screening of patients
• May perform data review, generating queries and reports; generating data discrepancies and reviewing completed discrepancy documents
• Assists with study closure activities
• Contributes to ongoing department improvement/standardization initiatives
• Assists clinical management with other duties as requested
REQUIREMENTS
• Familiar with clinical systems for trial management
• Proficient knowledge of medical terminology
• Knowledge of GCPs and regulatory and compliance guidelines for clinical trials
• Knowledge of medical device research
• Knowledge of cardiovascular anatomy/disease
• Ability to travel as needed 10-20%
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Romy van Ooijen.
