Clinical Research Associate (m-f-d), Germany, Rare Diseases

As a Clinical Research Associate (CRA) will have local responsibility for the delivery of the studies at allocated sites and be an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Leader to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.

This particular CRA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

• Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
• Conduct Investigator Profile and Clinical Site Initiation visits as well as Clinical Site Close-Out visits for studies of all phases (I, II, III, IV and NIS) in a range of different indications.
• Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans
• Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process
• Ensures appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs)
• Assist in preparing sites for audits, review audit reports and contributes to resolve findings

• BA/BS/BSc degree or similar
• Familiarity with ICH/GCP guidelines plus local codes of practice as applicable
• Experience working as a CRA for 1 year
• Fluent in English and German
• Willingness to travel
• Good working knowledge of common software packages
• Flexibility and Team skills

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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