Experienced Clinical Research Associate (Sign-On Bonus eligible)

Medpace, Inc.; Deutschland; Vor Ort; EUR 45.000 - 75.000; Vollzeit

Zusammenfassung

An established industry player is seeking an Experienced Clinical Research Associate to join their dynamic Clinical Operations team in Germany. This role offers an exciting opportunity to leverage your expertise while contributing to impactful clinical research projects. You will be responsible for conducting site visits, ensuring compliance with protocols, and enhancing patient recruitment strategies. With a focus on professional development and a commitment to improving patient lives, this position allows you to make a significant difference in the healthcare landscape. Join a team that values purpose and passion, and be part of a mission that accelerates the development of safe and effective medical therapeutics.

Qualifikationen

• Minimum of a university degree in a health or life science related field.
• 1.5 years of CRA or 2.5 years of CRC experience required.

Aufgaben

• Conduct monitoring and closeout visits for research sites.
• Verify investigator qualifications and ensure compliance with protocols.
• Complete monitoring reports and follow-up letters.

Kenntnisse

Communication Skills

Detail-oriented

Time Management

Presentation Skills

Clinical Patient Management

Protocol Compliance

Ausbildung

University Degree in Health or Life Science

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 even 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. Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
3. Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
4. 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;
5. Verification that the investigator is enrolling only eligible subjects;
6. Regulatory document review;
7. Medical device and/or investigational product/drug accountability and inventory;
8. Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
9. Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement;
10. Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications

1. Must have a minimum of a university degree in a health or life science related field;
2. Min. 1.5 years of previous experience as a CRA or 2.5 years of CRC experience.
3. Approximately 60-80% travel in Germany, Austria and Switzerland;
4. Proficient knowledge of Microsoft Office and general computer literacy;
5. Outstanding communication and Presentation skills;
6. Must be detail-oriented and efficient in time management;
7. Excellent verbal and written communication skills in English and German;
8. Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF, documentation to be submitted to competent authorities.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Awards

1. Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
2. Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.