Job Description
Sr. No. Job Responsibilities
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 .
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 .
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