Home-Based Experienced Clinical Research Associate

Our clinical activities are growing rapidly, and we are currently seeking an Experienced Clinical Research Associate to join our Clinical Operations team in Germany. This position will work on 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 further, then this is the opportunity for you.

Responsibilities

1. Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
2. Communicate with medical site staff including coordinators, clinical research physicians, and their staff;
3. Verify investigator qualifications, training, resources, facilities, laboratories, equipment, and staff;
4. Verify medical records and research source documentation against case report form data, ensure good documentation practices, and communicate protocol deviations according to SOPs, GCP, and regulatory requirements;
5. Ensure investigator enrolls only eligible subjects;
6. Review regulatory documents;
7. Manage medical device and investigational product/drug accountability and inventory;
8. Review adverse events, serious adverse events, concomitant medications, and illnesses for accurate data reporting;
9. Assess site patient recruitment and retention, and suggest improvements;
10. Complete monitoring reports and follow-up letters, summarizing findings, deviations, deficiencies, and recommended actions.

Qualifications

1. University degree in a health or life sciences field;
2. Minimum 1.5 years of CRA experience or 2.5 years of CRC experience;
3. Approximately 60-80% travel within Germany, Austria, and Switzerland;
4. Proficient in Microsoft Office and general computer literacy;
5. Excellent communication and presentation skills;
6. Detail-oriented with effective time management;
7. Fluent in English and German, both verbal and written;
8. Experience in clinical patient management, protocol adherence, CRF, ISF preparation, and documentation submission to authorities.