Sr . CRA ( Medical writer )

• 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
  
  6) 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
  
  

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