| Scientific Achievements: |
Professional experience and Training :-
• Worked as a trainee on operational and regulatory aspects of clinical trial for 2 months in MAX SUPER SPECIALITY HOSPITAL, Saket, New Delhi and MAX NEEMAN INTERNATIONAL, Okhla, New Delhi.
• Hands on Exposure at Ranbaxy Laboratories Ltd, CPU Majeedia Hospital and CPP Gurgaon.
Assisted in conduct of:
? Bioavailability (BA) and Bioequivalence (BE) studies.
? Enrolment of volunteers (VDMS, LDMS).
? Screening of volunteers.
Designing of Various Documents for BA/ BE Studies Like:
? Preparation of protocol
? Case Report Form (CRF)
? Informed Consent Form (ICF)
? Standard Operating Procedure (SOP)
? eCTD
Experience in AIIMS Department of Pharmacology:-
• Dissertation project completed at Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi.
• Well versed with reporting of adverse drug reaction in suspected adverse drug reaction reporting form (SADRRF).
• Knowledge detecting & assessing ADRs from OPD.
• Training in VIGIFLOW handling at ADRM Centre, AIIMS, New Delhi.
1. Completeness and maintenance of Investigator site file
2. Follow-up with the subjects enrolled into the study
3. Maintenance of source documents and look for completeness of the subject records/documents
4. Completion of respective CRFs for the subjects (including web transfers).
5. Query resolution
6. Coordination with the PI
7. Contact point for patients/ Sponsor local colleagues for trial related activities |
