Experienced Clinical Research Associate with German

Our clinical activities are growing rapidly, and we are currently seeking an Experienced Clinical Research Associate German speaker to join our Clinical Monitoring team. This position will work with a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

The Clinical Research Associate at Medpace is offered the unique opportunity to be involved at every stage of the drug development process by providing unrivalled support to our customers. If you want an exciting career where you use your medical or health background and education, travel extensively and are instrumental in the clinical trials process, this could be the opportunity for you. Our successful Clinical Research Associates possess varied backgrounds in the medical and related healthcare fields. Individuals who have succeeded in the CRA role include Registered Nurses, Dieticians, Pharmacists,Faculty of Science Graduates and Research Assistants. An extensive training program provides the platform to effectively and confidently carry out your duties.

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

• At least 18 months of experience as a CRA;
• Master degree in health-related field;
• CRA certification completed (as per DMC 15/11/2011);
• Willing to travel on Italian and Swiss territoy;
• Familiarity with Microsoft® Office;
• Fluent in English and German language;
• Strong communication and presentation skills a plus.