1. Overall responsibilities are to ensure that the study is being conducted in accordance with the protocol, SOPs, GCP/GCLP, and applicable regulatory requirements. 2. Performs site monitoring, which involves visiting the sites on a regular basis. 3. Completes appropriate protocol and clinical research training to perform job duties. 4. Setting up the trial sites such that each center has the trial materials, including the trial drug while ensuring all trial supplies are accounted for. 5. Provides training/re-training to the site staff and Training newly appointed CRAs on protocol, e-CRF, CTMS report preparations and study specific requirements/tasks as assigned by line manager. 6. Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues. 7. Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. 8. Manages the progress of assigned studies by tracking regulatory/ IEC submissions and approvals, recruitment and enrolment, CRF completion and submission, query generation and resolution. 9. Verifying that data entered into the CRFs/Lab management system is consistent with patient clinical notes (source data/document verification/Ultra-sound scans) and samples collected. 10. Performs Lab monitoring visits on a weekly basis.11. Performs data monitoring of laboratory and biorepository samples through online Lab monitoring systems. 12. Creates and manages reports regarding Lab and biorepository monitoring visits.

1. Supports creation, maintenance, and periodic review of Trial Master Files, Tools, and Systems for accuracy and completeness as per the regulatory and GCP requirements. 2. Involved in project tracking activities for efficient management of the SoW for respective assignment-related projects/ assignments. 3. Maintains tracker of SoA and flags the delays. 4. Conducted 25+ independent monitoring visits, identified gaps in ISF, and closed them.5. Prepares documents for IEC submission and notification. 6. Assisted Hospital sites in the EC submission process 7. Done CTRI registration of Research studies8. Participate in project-related meetings and assist in the preparation of agendas, presentation materials, minutes, and tracking of action items.9. Keep track of the consumables at the site. Raises timely indent requests for a proper inventory at all times10. Assist the project team in the preparation, handling, distribution, filing, and archiving of clinical study documentation as per departmental SOPs and project requirements.11. Provide support for administrative tasks and other clinical operations tasks assigned. Coordinate with cross-functional departments for travel and accommodation arrangements for delegates of project meetings, investigator meetings, etc. - Assist project teams in vendor payments and maintain tracking of payments.12. Assist in administrative tasks of manpower recruitment and coordinate candidate interviews. Managing a team of 60 employees currently.

1. Coordinated SQV/SIV & IEC approval facilitation for Max Institute of Cancer Care (MICC) 2. Facilitated Feasibility questionnaires on behalf of the site.3. EC Dossier submission4. Conducted Oncology Phase III and Phase IV studies.5. Has experience in Real-world Evidence Data collection6. Budget Preparation, Preparation of Utilization certificates, and Statement of Expenditure (SoE)7. ICH-GCP E6 certified and trained on different study-specific protocols and therapeutic areas.8. Data Collection and Preliminary analysis for Principal Investigator initiated studies9. CTRI Registration of Clinical Trials and research studies.10. Drafting ICF and PIS for 35+ research studies.11. Assisted in the Informed Consent Process/Audio-Video Consenting.12. Maintained Trial Master File (I-TMF)13. Managing study material and investigational products ordering, tracking, storage, dispensing, reconciliation, destruction, and maintaining the temperature range of IP and non-IP as per study protocol.14. Performed Study Closeout Visits.15. Archiving trial documentation

I worked in the Quality control (QC) department and performed qualitative phytochemical analysis of raw products