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

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📌 Sr Cra Medical Writer Thane
🏢 Bio Scientific Research Laboratories (BIOSRL)
📍 Thane