Ethic Medical Research Ltd. provides qualified and experience study coordinator to study site according to study design. Study coordinators perform high quality data collection, data capture and data entries based on study protocol and international/national regulations. Our coordinators have been trained ICH GCP and local regulations. We work with qualified and experienced study coordinator to provide our client with quality and cost effective site coordination in adherence to ICH GCP and local regulations. Also study coordinator performed responsibilities related study protocol but not limited with listed below.
Responsibilities;
1- Knowledge of ICH, GCP and Local Regulations.
2. Identifies, develops and reviews assessment tools, data collection tools and methods to collect data in consultation with the Principal Investigator.
3. Provides data entry and monitors the quality of the database
4. Assists the PI in promoting the project and its objectives to the clinical team and to external community partners.
5. Represents project at local, national and international meetings.
6. Ability to understand protocol requirements and communicate those requirements to clinical/laboratory staff.
7. Participate in the early planning phases of clinical study by providing assistance in the preparation of study proposal timelines, scheduling and other study requirements as appropriate.
8. Evaluate, coordinate, and ensure the completion of all protocol related documents
9. Assure resolution of all Quality control discrepancies related to data and research documents.
10. Coordinate with Sponsor Company to ensure timely submission of regulatory documents to EC (if necessary) and CRF completion.
11. Assure prompt AE/SAE reporting
12. Perform all duties and responsibilities in accordance with CFR, GCP/ICH and other applicable guidelines.
13. Assist to PI site regulatory file for completeness and accuracy on an on-going basis.
14. Strong communication skills and problem solving skills
15. Participate in trainings
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