Overview
In this home-based role in Austria, you support the clinical operations team by overseeing site qualification, initiation, monitoring and closeout to ensure protocol adherence and data integrity. You will liaise with site staff, verify investigator qualifications and resources, and ensure regulatory compliance and accurate adverse event reporting. This position involves substantial cross-border travel in D-A-CH regions and offers growth within a global CRO focused on accelerating therapeutics development.
Leistungen / Benefits
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Verantwortungsbereiche
- Conduct qualification, initiation, monitoring and closeout visits at research sites per protocol
- Communicate with site staff including coordinators and investigators to ensure compliance and quality
- Verify investigator qualifications, training, facilities, and resources
- Verify data quality through medical record and source documentation checks and adherence to GCP/SOPs
- Ensure enrollment of eligible subjects and regulatory document review
- Manage device and/or investigational product/drug accountability and inventory
- Review adverse events and concomitant medications for accurate reporting
- Assess and improve site recruitment and retention performance
- Prepare monitoring reports and follow-up letters with action plans to secure compliance
- This role is home-based with significant travel
Zentrale Anforderungen
- University degree in a health or life science related field
- Minimum 1.5 years of experience as a CRA
- Approximately 60-80% travel in Germany, Austria and Switzerland
- Proficient in Microsoft Office and computer literacy
- Outstanding communication and presentation skills
- Detail-oriented and strong time management
- Fluent in English and German (verbal and written)
- Proven experience in clinical patient management and regulatory documentation (ISF, CRF, submissions)
- strong communication
- presentation skills
- attention to detail
- Microsoft Office
- GCP awareness/regulatory documentation
- ISF and CRF preparation
Experienced Clinical Research Associate (remote-based) Arbeitgeber: Medpace
Medpace ist ein hervorragender Arbeitgeber, der eine flexible Arbeitsumgebung und ein wettbewerbsfähiges Vergütungspaket bietet. Mit strukturierten Karrierewegen und zahlreichen Möglichkeiten zur beruflichen Weiterentwicklung fördert Medpace das Wachstum seiner Mitarbeiter in einem unterstützenden und wertschätzenden Arbeitsumfeld. Die Anerkennung als eines der erfolgreichsten mittelständischen Unternehmen in den USA unterstreicht die positive Wirkung, die unsere Arbeit auf das Leben von Patienten hat.
