Description

Preparation of Protocol, study specific informed consent form and other regulatory documents. Preparation of Clinical Study Report after completion of study. Preparation and review of clinical SOPs. Raise change control documentation for clinical SOP, Instrument and equipment. Performing screening related activity like registration, biometric verification, demographic examination, alcohol consumption test, drug of abuse test. Assist the principal investigator in conduction of protocol meeting. Distribution of ICF for volunteers and group counselling of subjects. Assist the physician/ Principal investigator/ Clinical investigator in presentation of informed consent form. Preparation of labels for sample collection and sample storage. Conducting and monitoring dispensing and dosing activity. Performing sample processing, sample segregation and transfer activity. Monitoring clinical activities like blood collection, sample processing, meals and restriction activities. Preparation, reviewing and compilation of study documents (TMF, CRF, ICF etc). Recording the subject check in and check out details. Coordinate with clinical vendor like canteens, pathology lab, hospital, ambulance services, insurance company for study intimation.

Role and Responsibilities

• Preparation of Protocol, study specific informed consent form and other regulatory documents. Preparation of Clinical Study Report after completion of study. Preparation and review of clinical SOPs. Raise change control documentation for clinical SOP, Instrument and equipment. Performing screening related activity like registration, biometric verification, demographic examination, alcohol consumption test, drug of abuse test. Assist the principal investigator in conduction of protocol meeting. Distribution of ICF for volunteers and group counselling of subjects. Assist the physician/ Principal investigator/ Clinical investigator in presentation of informed consent form. Preparation of labels for sample collection and sample storage. Conducting and monitoring dispensing and dosing activity. Performing sample processing, sample segregation and transfer activity. Monitoring clinical activities like blood collection, sample processing, meals and restriction activities. Preparation, reviewing and compilation of study documents (TMF, CRF, ICF etc). Recording the subject check in and check out details. Coordinate with clinical vendor like canteens, pathology lab, hospital, ambulance services, insurance company for study intimation.