Senior Clinical Research Associate

at

Ergomed

Kraków, Poland
Full Time
9mo ago

Company Description

Founded in 1997 by a  Medical Doctor, Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for  complex trials in Rare Diseases, Oncology and Neuroscience.

Job Description

  • Perform on site monitoring
  • Verify study conduct is in compliance with currently approved protocol/amendments, ICH GCP, and report deviations per study procedures
  • Verify the rights and well-being of human subjects and confirm subject safety and data integrity
  • Verify that the investigator has adequate qualifications and resources, for safely and properly conducting the clinical study
  • Act as the main point of communication with Investigator and site team
  • When requested, support preparation of regulatory submissions
  • Verify correct drug storage and accountability
  • Maintain all files, documentation and perform regular QC
  • Motivate sites to achieve recruitment targets
  • Deal with system generated queries in a timely manner
  • Assume additional responsibilities as directed by PM / CTM / PD

Qualifications

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Demonstrated Monitoring Experience
  • Full working proficiency in English
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel

Additional Information

We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology. This is an ideal position to develop a career in clinical drug development. It offers the chance to progress into clinical  team management or project management.
 

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Onkar By: Onkar