Study Coordinator
Study coordinator services are provided according to trial design and need, delivered by expert staff. Our coordinators have completed ICH GCP and local regulation training and, under investigator supervision, ensure that data of the required quality is collected and entered in line with protocol requirements and national and international standards.
The duties of our study coordinators are not limited to those listed below; they also carry out responsibilities specific to each trial protocol.
Responsibilities
- Knowing ICH GCP and local regulations and carrying out all duties in compliance with ICH GCP and other applicable guidelines
- Collecting trial-specific data together with the principal investigator and ensuring records are stored securely with restricted access
- Performing electronic and paper data entry under investigator supervision
- Understanding trial requirements thoroughly and maintaining good communication with the trial team and relevant units outside the site
- Representing the trial at national and international meetings
- Planning in line with trial requirements, meeting expected timelines and assisting investigators
- Ensuring quality control of data and trial documents and resolving discrepancies
- Ensuring trial documents requiring Ethics Committee submission are submitted on time
- Ensuring serious adverse events are reported immediately to the Ethics Committee and sponsor
- Keeping site files current and valid and assisting the principal investigator
- Having strong communication and problem-solving skills
- Observing the confidentiality principles of the trial and not sharing information with third parties
- Attending trial-related training