Smita Nimkar MSc

CRS:

BJMC

Role:

Regulatory and Data Management

Position:

Regulatory Coordinator

Email:

nsmita13@gmail.com

Smita Nimkar is Regulatory Coordinator and IRB/EC Liaison for the clinical research site (CRS) at BJ Government Medical College (BJGMC) in Pune, India. The BJGMC CRS is part of the Baltimore-Washington-India Clinical Trials Unit (BWI-CTU)—which conducts clinical trials under the NIH ACTG and IMPAACT Trial Networks—along with the Johns Hopkins CRS (Baltimore, MD) and the Whitman Walker Health CRS (Washington, DC). She works with the India research team to ensure training on and compliance with scientific regulatory standards at all levels, assists with all submissions to IRBs including new protocols, progress reports, amendments, reviews, adverse event reports, and other assurance requirements. She is Vice Chair of the ACTG -Site Management Clinical Care Committee (SMCCC), ex member of IMPAACT Training and Education Committee, Life Member of the Forum for Ethics Review Committees in India, and member of Public Responsibility in Research (PRIM&R). Smita has worked in healthcare for more than 20 years, and her experience includes HIV/AIDS work, and clinical pathology, clinical research, contract research, and integrated research (Modern and Traditional) to develop new drugs and formulations from medicinal plants, She also has coordinated several research projects on communicable and non-communicable diseases. She is currently pursuing a PhD in health sciences.

  • Co-vice chair, Site Management and Clinical Care Committee (SMCCC)
  • Field Representative ACTG 5365, ACTG 5373, ACTG 5384
  • Nishi Suryavanshi, GauriRaval, Savita Kanade, Smita Nimkar, VaishaliNadgiri, PrassanaSahu, DeelipKadam, Sandhya Khadse, VidyaMave,, Nikhil Gupte, Amita Gupta, Anita Shankar, Challenges to disclosure of HIV status to perinatally infected children: A study of caregiver perspectives in Pune, India, Journal of Pediatric Infectious Diseases, Vol 9, No.2/2014

Categories

Leadership Committees
CRS
Roles

Clinical Trials

A5361s: Pitavastatin to REduce Physical Function Impairment...

A5361s is a prospective study to determine the effects of pitavastatin on physical function. The study will enroll participants...

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A5332: Randomized Trial to Prevent Vascular Events in HIV...

REPRIEVE (A5332) is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 months....

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NWCS 408: Examining Longitudinal Cytokine Profiles in HIV-TB...

Using existing data from A5274 and data obtained from retrospectively testing available biospecimens, we propose the following...

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Impact of Tuberculosis Infection on HIV-1 Antibody Response...

Study Objective: Compare longitudinal HIV-1 antibody responses among HIV-1 infected participants that either did or did not...

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A5279, Phase III Clinical Trial of Ultra-Short-Course...

This study will enroll HIV-infected people who do not have evidence of active TB but who are at high risk of developing active...

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