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

ACTIV-2/A5401: Adaptive Platform Treatment for Outpatients...

Rationale: There is an urgent need for a platform to rapidly evaluate therapies in the outpatient setting, to prevent disease...

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P2026: Pharmacokinetic Properties of Antiretroviral and...

IMPAACT P1026s, the predecessor of this study, was first approved in 2003. P1026s enrolled over 1000 pregnant/postpartum women,...

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A5290, A Randomized, Phase 2b Study of a Double-Dose...

Rifampin (RIF), the cornerstone of TB treatment, has very problematic drug-drug interactions with PIs. The use of relatively...

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A5327: Sofosbuvir + Ribavirin w/o Interferon for Treatment...

A5327 SWIFT-C is a Phase I, open-label, two-cohort clinical trial, in which between 44 and 50 acutely HCV-infected HIV-1...

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A5324: A Randomized, Double-Blinded, Placebo-Controlled...

ACTG A5324 is a phase IV randomized, double-blinded, placebo-controlled study to assess the efficacy of adding Maraviroc (MVC)...

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