Responsibilities as Project coordinator:
- Responsible for planning, coordination and overviewing of study related activities.
- Arrangement of protocol training and assisting Investigators delegation of activities to the study personnel as per their job responsibilities.
- Coordination with Investigators, screening and study team during conduct of the study.
- Coordination with PMO team for assisting of monitoring visits.
- Coordination with other departments [Central Laboratory, Bioanalytical Laboratory and Data Management] during conduct of the study.
- Accompanying and assisting study specific monitors during monitoring activities as per the monitoring plan.
- Arrangement of study ICDs and CRFs in coordination with QA and documentation controller.
- Responsible to request QA/Document Controller (DC) team for issuing required number of study forms and CRFs well prior to the start of the study.
- Responsible to collect study forms and CRF forms from QA/DC team for study activity per the given request and handover the same to respective activity in-charge personnel of the study to document the same.
- Responsible to hand over completed and reviewed CRF forms to QC personnel after filing in the respective study file.
- Ensure readiness of essential documents in Trial Master File.
- Responsible for filing of the duly completed CRF forms in respective study files.
- Coordinate with QCs for documentation review process.
- Preparation of periodic study updates and coordination with Project manager for providing study updates or any operational documents to sponsor.
- Coordination with Investigators for providing periodic study updates to EC/IRB.
- To carry out other responsibilities that may be assigned by Principal Investigator, Head-Human Pharmacology Unit/Head of Syngene Clinical Development Team.
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