1 Protocol, Informed Consent From (ICF), case report form (CRF) Preparation:
Coordinate with clinical research personal for of Protocol.
Coordinate with clinical research personal for preparation of ICF and CRF
2 Ethics submission :
Coordinate with the investigator for submitting the study related documents (clinical updated) to independent Ethics Committee.
3 Subject Recruitment/ Screening :
Coordinate with screening team for subject recruitment & screening.
4 Study Related :
Coordinate with the investigator for planning of study schedule.
Ensure that all the volunteers reported for ICF presentation are fit for participation in the study as per the respective protocol.
ICF presentation at the time of participation of subjects in a particular study.
Conducting clinical examination and monitoring vitals for well-being of subject during the study.
Responsible for safety and well being of study subjects.
Handling & Reporting of adverse events and drug reactions and clinical emergencies in co-ordination with investigator.
Clinical decision in the absence of investigator and take opinion of investigator as and when required.
Guide the nursing staff in maintenance of emergency medicines and special care room.
Provide medical help to the employees as well as subject.
Monitor the study and ensure that the study is conducted as per approved protocol, international conference on harmonization Good clinical Practice (ICH-GCP) and on house standard operating procedure. (SOP)
Coordinate with clinical staff for admission, discharge, meal distribution dosing/ dosing supervision and monitoring the subjects during study for restriction compliance.
Generation and maintenance of essential documents preparing to study.
5 Report preparation:
List out protocol deviations/ SOP deviations related to clinical examination and vital measurement and incorporate the same in final report in consultation with the investigator.
6 Feasibility assessment :
Coordinate with the clinical research for feasibility assessment of various molecules .