Priyanka Patil

I like to adhere to my work ethics which has helped me to achieve my goals. My dream is to be part of a team that will lead not only to finding palliative solutions to those in pain but also to participate in discovering permanent ones. There is nothing better than utilizing your passion for something to assist the people and contribute to the betterment of life.

Tata Memorial Hospital, Parel, Mumbai, Maharashtra

Clinical Trial Coordinator, March 2022- Present

& Research Assistant, Jun 2021- Feb 2022

 Coordinating Pharma and investigator initiated Clinical trial (National/International) in the field of Oncology.

 Coordinated between the Site and Sponsors/CRO effectively.

 Assist the Principal Investigator (PI) in the conduct of clinical study according to GCP, Site SOP and Sponsor regulations and guidelines and ensure the safety and welfare of the research participants.

 Submission of initial EC dossier to IEC/IRB in coordination with CRO/Sponsor.

 Negotiation and Finalization of sponsored trial budget with CRO/Sponsor.

 Patient recruitment as per inclusion and exclusion criteria. Patient follow-up as per study protocol timelines.

 Maintain Site Master File (SMF) and completion of case report form (Paper CRF, EDC) within a given timeline.

 Submissions and Notifications of study related documents to IRB/IEC.

 Study registry in HMSC, CTRI, BioRRap and Department of Atomic Energy (DAE).

 SAE reporting within timelines, maintaining follow-up, writing SAE narrative.

 Reporting of Deviations and assisted team to limit deviations.

 Documentation of Adverse event to subject file and EDC (Event description, Severity, Treatments,

Resolution).

 Maintenance of logs such as screening and enrolment log, Subject identification log, Temperature log, Drug dispensing and accountability log.

 Assisted Principal Investigator to review studies for feasibility and submitted feasibilities to CROs.

 Ensured Quality, consistency and accuracy in the conduct of clinical research trials.

1. Drug Regulatory Affairs Chemist, Pollux Life Science Solutions LLP, Mumbai. (2020)
2. Post Graduate Diploma in Clinical Research, R. J. College, Mumbai University (2019) 
3. Master and Bachelor of Biotechnology, G. N. Khalsa College, Mumbai University (2020)