Dr Neetii A Shah

Experience

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  Hemato Oncology Clinic

  Mar 2009 - Jun 2011

  Lead Research Monitor and Medical Officer

  Responsible storage of Study patient’s files and documents for the reference of Doctors as well as Clinical Research Associate • Performing all the Ethics Committee submissions, and notifications in a timely manner. . •Assisting in taking consent from the patient to undergo the trial. Enrolling the patient in the trial on the Electronic Data Capture system and capture patients E- Code number. •Once patient is randomised, making the necessary data entries in the system to procure medicine batch numbers and dispensing it to the patients. •Counseling study subjects and give instructions as per study protocol, usage of drugs, next visits etc. •Completion of all study related work starting from the enrolment, randomizing and discharging the patients to monitoring their visits till the completion of study. Show less

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  INC Research

  Jul 2011 - Apr 2017

  Acting as site liaison to develop and maintain rapport with study site personnel, vendors, sponsors and INC team members. •Assistance with the development of materials for and performs regulatory document collection and tracking (where applicable), technical support, pre-study, study initiation, monitoring, site management, and close-out activities via telephone while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Plans. •Performing in-house site support activities, researching and responding to various site inquiries (study materials, protocol, systems use, study documents, CRF conventions, queries, payments, etc.), appropriately tracking and documenting these interactions. •Assisting in the development of and maintaining study documents such as CRFs and CRF completion guidelines, mailing/faxing materials, newsletters and telephone scripts •Participating in the preparation and coordination of investigator meetings or other investigator site training and attending investigator meetings as requested. •Performing quality control (QC) activities across all areas of project responsibilities. •Establishing working relationships with other INC personnel to ensure that study-specific documentation is retrieved, filed and maintained in a high quality, timely quality manner. •Anticipating/identifying potential problems and implementing corrective actions. Suggests and implements alternative solutions to problems with study timelines, schedules, resources, etc. to department or study management. •Providing support for study awareness, patient recruitment, and investigative site activities, including manning toll-free public call center and investigative site help lines. Serves as a central contact point for public inquiries regarding studies. . •Prepares and distributes regular status reports •When requested, provides support by assisting with limited monitoring activities on site. Show less

  • Global Feasibility Analyst

    Sept 2012 - Apr 2017

  • In-house CRA I

    Jul 2011 - Aug 2012
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  Syneos Health

  Apr 2017 - Sept 2019

  Feasibility, Data Science Lead

   Support projects through the application of data and analytics expertise Use analytical tools to assess known and unknown information provide probabilistic estimation of risks to study  Translate clinical trial execution challenges into implementable solutions Assume leadership role in evaluation of new informatics technologies Use analytical expertise to prepare risk benefit analyses and decision making criteria Communicate value of informatics tools to users and spearhead training of internal clients Query relevant databases, and research various literature sources to support preparation of robust feasibility, site identification and selection deliverables Actively participate in developing relevant metrics to measure the impact of protocol feasibility assessments, recruitment support, site identification and selection activities Analyze metrics to identify trends, correlations, best practices, issues and opportunities for process improvement Assume leadership role in special business development projects in protocol feasibility testing, ps Demonstrate expertise and present findings on enrollment modeling and predictive analytics Show less

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  Thermo Fisher Scientific

  Sept 2019 - now

  Feasibility Strategist ( Senior Manager )