Home-Based Experienced Clinical Research Associate

Medpace; Deutschland; Vor Ort; EUR 45.000 - 70.000; Vollzeit

Zusammenfassung

An established industry player is seeking an Experienced Clinical Research Associate to join their Clinical Operations team in Germany. This role offers a unique opportunity to leverage your expertise in clinical research while contributing to impactful projects. You will conduct site visits, ensure compliance with protocols, and communicate effectively with medical staff. With a focus on professional growth, this position promises an exciting career path in a dynamic environment. If you are detail-oriented, possess excellent communication skills, and are ready for travel, this role is perfect for you.

Qualifikationen

• Minimum 1.5 years of CRA experience or 2.5 years of CRC experience.
• Experience in clinical patient management and documentation submission.

Aufgaben

• Conduct qualification and monitoring visits for research sites.
• Communicate with medical site staff and verify qualifications.
• Complete monitoring reports summarizing findings and actions.

Kenntnisse

Clinical Research Associate (CRA) experience

Clinical Research Coordinator (CRC) experience

Communication skills

Time management

Proficient in Microsoft Office

Fluent in English

Fluent in German

Ausbildung

University degree in health or life sciences

Tools

Microsoft Office

Jobbeschreibung

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.