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CRA II

  1. Germany
2024-114546
  1. Clinical Monitoring
  2. ICON Strategic Solutions
  3. Remote

About the role

The Clinical Research Associate II will perform site activities for Phase I-IV studies operating as the main point of contact for the site during a study. Drive and execute monitoring plans, ensure site GCP compliance, write trip reports, resolve issues and facilitate open issue resolution, work on recruitment strategies, and monitor safety at the site.  The CRA  will conduct site qualification visits as assigned, site initiation visits and site training, routine monitoring visits, and site close-out visits. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).

 

You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.

 


What you will be doing:

  • Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
  • Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
  • Balancing sponsor generated queries
  • Taking responsibility for study cost efficiency
  • Preparation and review of study documentation and feasibility studies for new proposals
  • Potential to assist in training and mentoring fellow CRAs

You are:

  • At least 18 months of experience as an independent CRA, including conducting monitoring visits for clinical trials, from either a pharmaceutical company or a CRO environment
  • A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential
  • You will be educated to degree level in a life science discipline or be a licensed healthcare professional
  • Fluency in German and English is essential
  • Scientific degree (BSc, MSc or PhD), have equivalent experience or be a licensed healthcare professiona
  • Excellent verbal and written communication skills in German and English
  • Ability to manage the sites independently



Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

 

#LI-SC3

 

List #1

Day in the life

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Publish date

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Publish date

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