Founded in 1997 by a Medical Doctors , 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. We are looking for a CRA to cover Netherlands and Belgium sites.

Duties and Responsibilities of the   CRA/Monitor II are:

• To verify that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s), and report any deviation as per study procedure
• To verify that the rights and well-being of human subjects, clinical study’s participants, are protected and conducts monitoring to confirm subject safety and data integrity
• To identify the investigators and  verify that the investigator has adequate qualifications and resources, as well as that, facilities, including laboratories, equipment and staff are adequate for safely and properly conducting the clinical study throughout the study period
• To act as the main point of communication with Investigator and his team
• When requested to support preparation of regulatory and / or EC submission
• Participate in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance

Appropriate CRA experience and English, Dutch and French language skills

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 project management.