To match the demand of one our clients, we are searching for 2 experienced Clinical Research Associates (CRA), one to monitor in Germany, therefore knowledge of German is required. The other CRA will monitor sites in Canada, for this role a fluent knowledge of French is required.
Both CRA's will work an a medical device project for a CRO with offices in Belgium, since the sites are abroad, openess to travel is key.
A good understanding of the local language is important, since you need to able to understand patient files.
Don't hesitate to get in touch if you would like to have more information!
The Clinical Research Professional is responsible for site and/or project management related to clinical trials and core laboratory activities, ensuring that milestones, timelines, budgets and quality of such trials or projects, as outlined by the applicable study protocols or manuals, monitoring plans, SOPs, and applicable regulations and policies are met.
• Oversees and coordinates progress of clinical study and core laboratory projects at the participating centers and/or clients.
• Ensures that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements.
• Provides support in start-up, enrollment, follow up and closure of clinical trial and core laboratory activities.
• Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
• Plans and organizes non-routine tasks w/approval.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments.
• May interact with vendors.
• Participates in determining goals and objectives for projects.
• May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
• Represents the organization as a prime contact on contracts or projects.
• Interacts with senior internal management and external personnel on significant matters often requiring coordination between organizations.
• Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to management.
• Participates in the development and coaching of less experienced staff.
• Master degree in biological or (para-) medical sciences
• Minimum of 3 years’ experience as clinical research associate
• Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook)
Skills and Competences
• Exceptional oral and written communications skills and excellent interpersonal skills
• Team player towards the study teams
• Demonstrated ability to make timely and well-reasoned decisions
• Demonstrated ability to effectively and persuasively communicate verbally and in writing
• Demonstrated ability to identify and adapt to shifting priorities and competing demands
• Ability to maintain composure in difficult circumstances
• Feels challenged by creating metrics to measure performance
• Sensitive to cultural differences
• Fluent in English and French for monitoring in Canada, fluent in English and a good understanding of German for monitoring in Germany
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