Clinical Research Associate II
- Full-time
- Department: Clinical Operations
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.