We are looking for a Clinical Research Associate (CRA) who likes to travel internationally for studies in the field of Medical Devices:
- Do you have a first experience in trial monitoring?
- Do you love to travel and do you have a good knowledge of German?
- And are you looking for a flexible work environment (home-work)?
Then this is the opportunity you have been looking for!
For a project of one of our clients, we are looking for a German-speaking CRA who can manage the ongoing studies in Germany, Austria and Switzerland.
The Clinical Research Associate 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.
- Minimum 1 year experience in clinical research (study coordination/monitoring)!
- Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook)
- Exellent oral and written communications skills and excellent interpersonal skills.
- Team player towards the study teams.
- Sensitive to cultural differences.
- You are willing to travel internationally on a frequent basis
- 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.
- Fluent in English is a must, good knowledge of German, any other languages are a plus
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