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.
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
College / University degree in Life Sciences or an equivalent combination of education, training & experience
2 years on-site monitoring experience
Full working proficiency in English
Proficiency in MS Office applications
Ability to plan, multitask and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Ability to travel
Valid driver’s license (if applicable)
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.