Here at Syneos Health we are currently recruiting for a Senior Clinical Research Associate II to work on a sponsor-dedicated role in Germany.  

At Syneos Health we have a nice gift for CRAs – join our FSP team and get 7,5k € sign-on bonus!

The Clinical Research Associate performs routine site visits to ensure that the rights and well - being of human subjects are protected. Additionally, you will assist in training and mentoring other regional monitoring personnel. In doing this, the Clinical Research Associate represents Syneos Health and the sponsor to site personnel and colleagues with professionalism and integrity. 

Your main responsibilities:

Perform all kind of the monitoring visits, to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines.

Document each visit with a quality written monitoring visit report and submit to the reviewer.

Author and send follow up letter to investigative site documenting the visits.

Create monitoring visit reports ensuring finalization within contractual obligations.

Participate in feasibility studies.

Present study materials at Investigator/study launch meetings when required.

Train/mentor junior CRAs on monitoring, internal procedures, and query resolution.

Perform regulatory activities, if applicable.

The ideal candidate will need the following experience / skills to be considered:

Min. 5 years of on-site monitoring experience 

Very good knowledge of Good Clinical Practice/ICH Guidelines

Ability to prioritize

Proven ability to work independently in a fast-paced environment

Strong communication, interpersonal, and organizational skills.

Must demonstrate good computer skills  

Position requires approximately 60% travel

Fluency in German and a high level of English language
 

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.