Megha Gupta

• Identifying/selecting an investigator who will be responsible for the conduct of the studies at the study site.
• Liaising with doctors/consultants or investigators on conducting the study.
• Setting up the study sites, which includes ensuring each Centre has the study materials, including the study drug often known as the investigational medicinal product. Training the study staff in standard operating procedure for the clinical study as per applicable regulatory requirements.
• Verify that investigator and investigator’s team are adequately trained and comply with the protocol.
• Monitoring the study throughout specified duration involving monitoring visit to the study sites.
• Clinical project manager.
• Protocol writing.
• Source data verification.
• Designing & review Informed consent form, case report form and adverse event review.
• Data collection, Data entry, Data cleaning and Data Coding.

• Research Associate in Bio-banking & database development, preparing CRFs, and project execution
• A key role was to collect prospective & retrospective documents & samples (blood samples) for Breast cancer
• Exposure in studying pathological & treatment reports of these cancers, collection of samples in FFPE blocks as retrospective collection, in blood as prospective collection, and storing them in appropriate conditions
• Use analysis and interpretational skills to produce reports and analysis when required for research programs, local audits, and outcomes reports for clinical teams

Department: Dr Pradyut Waghray (Pulmonologists)

Responsibility:

• Patient screening
• Scheduling
• ICF
• Preparation of checklist
• Source documentation
• ECRF
• Notifications of AEs and SAEs
• Preparation and submission of trial-related documents for EC approval
• Coordinate between investigator and patient.
• Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.

Responsibility:

• Patient screening
• Scheduling
• ICF
• Paper CRF, Notifications of AEs and SAEs, Preparation and submission
• Patient counseling of kidney transplant (medicine & diet).

Department: Dr. (Prof.) Sandeep Guleria (Renal Transplant)

Responsibility:

• Patient screening
• Scheduling
• IC
• Paper CRF, Notifications of AEs and SAEs, Preparation and submission
• Preparation and submission of trial-related documents for EC approval
• Patient counseling of kidney transplant (medicine & diet).