Sonali Sundari Shivhare

Experience

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  The Akanksha Foundation

  Jun 2007 - Nov 2007

  Beyond School Executive
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  Kriger Research Group International

  May 2009 - May 2010

  Clinical Research Associate (monitor)

  Trained to monitor Clinical Research Studies as per ICH GCP and completed all necessary paperwork and communication. Helped with site initiation and site closeout - performed day to day entry level CRA (monitor) functions and obtained on the job training as a CRA (monitor).

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  UCI Health

  Dec 2010 - Jun 2011

  Clinical Research Coordinator
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  David Geffen School of Medicine at UCLA

  Dec 2011 - Oct 2020

  Manage and Oversee all aspects of Clinical Research in OBGYN-WHCRU, manage staff and finance. Was instrumental in growing the research enterprise exponentially (over 200%) between 2014-2018. Capabilities include clinical research project development (idea generation to implementation) and management (plan, execute, monitor & control and close), budget and resource feasibility (from couple hundred thousand to several million) and management. Supervise staff (7-10); monitor contracts, grants, and donor funds; allocate funds and resources as appropriate to accomplish goals; maintain the budget for the Unit and prepare grant financial reports; identify, assess and prioritize issues for discussions at meetings; analyze potential projects for feasibility and make recommendations; and organize events for the unit. Serve as primary liaison. Specialized regulatory function – help design PI initiated trials, help prepare and submit to FDA and other regulatory bodies. Show less Under the direction of the Medical Director and Administrative Director of the Clinical Trials Unit, coordinate the Department of OBGYNs Clinical Research Program at UCLA. Assure that cancer related, non‐cancer related and laboratory based research studies receive the appropriate regulatory approvals and are conducted in compliance with numerous policies and regulations. Perform regulatory duties for our affiliate institute Olive View Medical Center. Oversee the implementation of research studies. Help organize and conduct internal audits. Build and negotiate budgets; represent the unit in internal and external interactions. Supervise Study Coordinators/Data Managers and volunteers. Analyze potential projects for feasibility and make recommendations. Started a volunteer processing and onboarding program for the department. Show less Assure that cancer related, non‐cancer related and laboratory based research studies receive the appropriate regulatory approvals and are conducted in compliance with numerous policies and regulations. Worked with investigators one on one to support their regulatory needs, including but not limited to creating and submitting regulatory packets to IRB, IBC and other regulatory bodies/committees. Help draft protocols and study related documents, create and maintain regulatory documents and binders. Liaison with sponsors and UCLA central to ensure all regulatory needs have been met per regulations. Perform regulatory duties for our affiliate institute Olive View Medical Center. Perform functions of a study coordinator and provide guidance to other study coordinators. Help establish a standardized process and SOPs within the unit for various clinical research processes. Show less

  • Director - Women's Health Clinical Research Unit

    Jan 2014 - Oct 2020

  • Sr. Admin Analyst and Regulatory Specialist

    Sept 2012 - Dec 2013

  • Regulatory Specialist and lead Study Coordinator

    Dec 2011 - Sept 2012
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  Fractional Roles in Medical and Health Technology Startups

  Jan 2013 - now

  Fractional Executive Roles in Medical and Health Technology Startups

  Serve fractional executive roles or take up projects in Medical and Health Technology Innovation startups. Positions held: COO, Chief of Staff, Consultant, Director of Operations, VP of Business Development and VP of Operations.Operations, Clinical Research, Clinical Research Management and Regulatory support and guidance to MedTech and BioTech startups, investigators and researchers. Research project Feasibility, Planning, Implementation, Execution, Monitoring and Control. Initial brainstorming, idea generation and strategy design. Some recent projects include diagnostics, nanotechnology, medical device, Phase II Oncology trial design, participant and provider training and onboarding. Oversee the day-to-day administration, operations, team management, compliance and regulatory for the Medical and or Health Technology Startup with direct involvement in strategic planning and growth. Show less

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  UCLA Health

  Sept 2018 - Jul 2019

  Program Manager

  Served as the UCLA Program Manager for a large U54 grant - UCLA-CDU Cancer Center Partnership to Eliminate Cancer Health Disparities. Ensured that the partnership functioned effectively, worked closely with PIs, CDU counterparts, Program Steering Committee and Internal Advisory Committee.

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  Stealth Mode AI/ML Startup

  Jan 2023 - now

  Chief of Staff & Operations