Vandana S.

Experience

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  Institute of genomics and integrative biology (CSIR)

  Jan 2005 - Jan 2007

  Project Assistant
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  Johns Hopkins Bloomberg School of Public Health

  Jan 2008 - Jan 2010

  Research Professional

  Primarily responsible for running malaria parasite culture CORE facility for the Malaria Research Institute, carrying out mosquito infection and dissection studies and participated in a variety of immunological and molecular biology projects, worked on SAP system of Hopkins.

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  Johns Hopkins School Of Medicine

  Feb 2010 - Sept 2014

  Sr Research Assistant

  The overall goal of research is to identify of the cellular and molecular mechanisms that control skeletal development and repair. Cell and mouse models with specific alterations in these pathways are being used to study the role of growth factors during bone development and following skeletal injury.

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  Kennedy Krieger Institute

  Oct 2013 - Aug 2014

  Student Worker

  Part of the natural history study which involves collecting/organizing the patient data of any of the patients with Albright’s :Follow Pediatrician in clinics and understanding of how to review clinical charts and collection of data and how to document that data . Handful experience in organizing clinical data and how to organize spreadsheetsExperience in Data Management, Data Archiving and patients chart. Exposure to obtaining Informed Consent

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  Harris Corporation/ NIH-NCI

  Sept 2014 - Dec 2014

  Clinical Data Manager II

  Analyze and record appropriate adverse events (AE’s) based on protocol requirements and individual judgment in applying those requirements. Collaborate with research team in resolving issues and concerns identified.Interpret, analyze and extrapolate data to create reports, graphs, and schemas for Principal Investigator (PI) analysis based on judgment, knowledge and understanding of study requirements. Collaborate with research team in resolving issues and concerns identified.Manage and conduct internal audits for regulatory compliance and analysis and verification of complete and accurate data based on medical and clinical understanding, and judgment. Develop requirements for corrective actions based on analysis.Analyze and ensure clinical research data integrity. Work with the research team to share findings and coordinate corrective actions as necessary.Analyze content of source documents (e.g. medical records, Hospital information systems) and abstract data considered appropriate for submission.Perform statistical analysis and develop and provide statistical reports that aid the research team in building hypotheses.Ensure the complete and accurate coding, abstraction and capture of patient informationManage submissions to sponsors and regulatory agencies based on knowledge and understanding of study requirements.Validate and reconcile data from multi-institutional study sites as required. Show less

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  National Center for Advancing Translational Sciences (NCATS)

  Dec 2014 - Jun 2016

  Clinical Research Coordinator/ Clinical Project Manager

  1) Assists in the preparation, reviews and comprehends the study protocol and IC. Prepare IRB/FDA and regulatory documents, continuing reviews, protocol deviations, protocol violations, involving risks to research participants or others to the IRB. Reporting unanticipated problems to the IRB and FDA and submitting IND safety reports and SAEs. Assists in developing IC, (CRFs), source documents, enrollment logs, and drug/device accountability logs. Corresponds with the IRB , schedule of visits, execution of research plan including organizing meetings, creating timelines.2) Protocol and Data Quality Control. Maintains study files in accordance with sponsor requirements and NIH policies. Prepares site for monitoring visits and FDA audits . Meets with study monitor for QC & QA3) Study proceedings and timelines, Patient screening, recruitment and enrollment . Assists PI in communication of study requirements to all individuals involved in the study. Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.). develop and implement recruitment strategies in accordance with IRB requirements and approvals. Assures that amended consent forms are appropriately implemented and signed. Registers participants to the appropriate coordinating center (if multi-site study). Coordinates participant tests and procedures. Maintains study timelines. Maintains adequate inventory of study supplies.4) Reporting -Assists with scientific and compliance reporting requirements in accordance with Federal regulations and IRB .Generates reports requires for SRC meetings, IRB. Maintains Clinicaltrial.gov updated . Facilitates timely and safe transfer of data to statistician for analysis of data Show less

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  GSK

  Jun 2016 - Nov 2021

  Manage/lead for focusing on the coordination of all activities required to evaluate, initiate, monitor and close clinical trial sites in accordance with regulations. Performs routine clinical trial site monitoring functions. Evaluates the Risk Signals of KRIs along with existing knowledge and experience of investigator sites to support appropriate monitoring intervention, frequency of intervention and areas to focus on during intervention. Development of clinical trial specific documents such as Monitoring Plan, CRF Completion Guidelines, etc. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirement. Supports and implements Risk Based Monitoring as directed. Participates in study team activities, such as PM lead, reviewer for study documents Show less Participate in developing strategy to deliver studies and best practicesAssociate role on Study Conduct Teams including but not limited to processing of regulatory documents, invoice processing and Selection of Investigational sites, Coordinate oversight of external (non-GSK) vendor managing third party support services to the site selection team like CDAs and state sanction support, KPIs for external partners.Support clinical development planning and country feasibility assessments at both study and portfolio level by providing projected subject recruitment timings and identifying new investigators , planning of Investigator meetingManage standardized regulatory document tracking systems per study and Generate and maintain list of investigators in various databases (e.g., eTrack, IntraLinks, etc.), Serves as eTrack Local Expert for North America -GSKUnderstanding of CARS and Sponsor Trial Master Files (eTMF), Ensure standardization and dissemination of best practices across studies, Communicate with and field questions from site staff, investigator and monitoring personnel, distribute all outgoing site communications, dissemination of Safety reports.Experience in participation of internal audits and resolving CAPA issues, Risk based monitoring Development of procedures and non-study related activitiesRequest, receive, QC and process all required regulatory, financial and legal documents; submit to appropriate departments and obtain Regulatory approval via the Xpress database for vaccine ship Show less

  • Clinical Research Associate

    Jun 2020 - Nov 2021

  • Senior CSA

    Aug 2017 - Jun 2020

  • CSA

    Jun 2016 - Aug 2017
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  Ocugen

  Nov 2021 - Aug 2022

  • Associate Director, Clinical Quality

    Apr 2022 - Aug 2022

  • Manager, Clinical Quality

    Nov 2021 - Apr 2022
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  Mersana Therapeutics

  Aug 2022 - now

  FDA ICH, MHRA, EMA

  • Director Clinical Quality Assurance

    Jan 2024 - now

  • Associate Director Clinical Quality Asurance

    Aug 2022 - now