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Ø Serve as Project Coordinator for Allotted project.
Ø Informed consent form review, case report form review, investigational drug accountability, and adverse event review.
Ø Writing visit reports, filing and collecting trial documentation and reports.
Ø Vast experiences and knowledge in the precaution of clinical safety
Ø Collecting the data of the research subject
Ø Vast knowledge in dispensing and dosing also
Ø Documenting the result of trial in the form of documentation, report to sponsor
Ø Monitor the subject throughout the full study
Ø Coordinate laboratory sample compile data
Ø Collaborate with medical professional to determine changes in subject condition
Ø Maintained SOP and good clinical practice in compliances with ICH guidelines
Ø Screened and recruited subject based on eligibility criteria for project participation
Ø To Review CRFs, Protocol, Medical Screening record, Informed Consent Form.
Ø Sample Separation, Segregation and Transfer to the Bioanalytical Department.
Ø Compilation, review and Quality checked for Clinical study raw data.
Ø Quality checked for all study related documents i.e. Subject Screening record, Inform consent form and Case record form.
Ø Responsible for Quality check of Clinical study PK sampling record, vital sign record and meal record.
Ø To carry out dosing of subjects enrolled in the Clinical Studies.
Ø Serving standardized meal to the study subjects.
Ø Preparation of Clinical Summary Report.
Ø Any other duties as assigned by Principal Investigator/Head Clinical Operations.
Ø To prepare the SOPs for clinical department and pharmacy also.
Ø Responsible for IP received, receipt, dosing, accountability ,retrieval and transfer or disposal after completion of study,
Ø Maintenance of temperature and relative humidity of pharmacy area and stability chamber
ICH GCP E6 R2, Centralized Monitoring
New advancements in cancer therapy, pediatric treatment, new breakthroughs in managing Lifestyle diseases etc.
Human Body`s
Cadiovascular system related
Nervous system related
Orthopaedic system related
Dermatologically realted
Ophthalmologically related
Paediatric medicne and surgery related
Site Selection, Monitoring, protocol, study reports
resaerches in pediatric disease , supportive care and oncology
The emergence of Micro RNAs as potential biomarker in several disease areas. In recent years, there has been a lot of interest in this field and many pre-clinical studies are being carried out across the globe. We will hopefully see some promising results in the near future, where we will be able to translate the science from the benchside to bedside.
New Frontiers in treament of cancer
New antibiotics therapy for Critically ill patient
the growing resistance to antimicrobial therapy in some infections
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