Clinical Research Associate

Senior-Principal Clinical Research Associate

Company:

Our Client is a leading Clinical Research CRO across Phases I-IV, they have been providing vital services for their extensive client list for decades. Established international they have experts across multiple functions in life sciences with over a dozen therapeutic areas in their area of expertise, with a presence of in over 40 countries.

In this company you can grow and develop your own skill set in a large variety of different functions and therapy areas. Additionally you know that the projects you will be working on will provide a benefit to millions of people of people.

Location:

Austria, with travel across the DACH Region

Role

• Take the lead in monitoring vital sites across the DACH region
• Conduct qualification, initiation, monitoring, and closeout visits for research sites
• High level of communication with medical site staff including coordinators, clinical research physicians
• Verifying investigator qualifications, training and resources, including facilities, laboratories
• Medical record and research source documentation verification against case report form data and applicable regulatory requirements;
• Verification of the enrolment of eligible subjects for the sites
• Adverse events verification and review, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Required Experience

• Life Sciences education – for example BSc, PhD
• Ideally coming from a background as a Clinical Research Associate
• Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF, documentation to be submitted to competent authorities.
• High level of site management
• Outstanding communication and Presentation skills;
• Must be detail-oriented and efficient in time management;
• Excellent verbal and written communication skills in English and German;

Interested in learning more? Then don’t hesitate to apply! I’ll be looking forward to discussing the role with you.