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Prafulla Bhagat

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SUMMARY

Research Study Coordinator/ Data Manager with over 5 years of experience in Hematology/ Oncology Clinical Trials.

With multiple skills and varied experience, I can make a difference to bring a positive accountable change to the organization by delivering outstanding results. My work contributes positively in health outcome for terminal disease patients by development of treatments through Clinical Trials for the approval of new medications and therapies for Blood Cancer.

WORK EXPERIENCE

Albert Einstein College of Medicine (Cancer Center) and Montefiore Medical Center, NY Nov 2017 – Current

Clinical Research Coordinator/ Data Manager

• Currently working on Hematology Disease Group (HEME malignancies, MDS and AML Phase-I, Phase-II and Phase-III Clinical Trials).

• Coordinate multicenter PI initiated institutional studies study startup activities like site initiation visits (SIVs), site qualification visit (SQVs).

• Managed routine operations of various clinical trials for NCI sponsored and AIDS Malignancy Consortium AMC sponsored ANCHOR Study.

• Coordinate all aspects of the research project with the study team and sponsors

• Managed data for Multiple Myeloma (MM) and Chronic Lymphocytic Leukemia

(CLL) study by Celgene, IQVIA.

• Worked with principal Investigator (PI) and data managers to extract medical record data, coordination of secure data sharing with study partners consistent with data use agreements and IRB regulations.

• Assisted in submissions to IRB in iRIS IRB system and BRANY IRB manager to make study related submissions (Consent Forms, Protocol)

• Assisted in coordinating, managing and analyzing data; perform regular audits checks to ensure that collected data are complete and accurate, matches source documents and in line with the research protocol.

• Managed clinical trials data collection (data entry into EDC system Medidata Rave® ANCHOR DMC, ADVANTAGE EDC, Oracle Inform 6.1)

(Review source documents for accuracy and completeness), and monitoring

(compliance with site SOP, best practices such as ICH, GCP, procedures and the applicable federal regulations CFR.

• Work with principal Investigator (PI) and site staff (RN, PA, DM) to keep them fully informed about day-to-day issues and study progress. Page 2 of 6

• Assist in coordinating, managing and analyzing data; perform regular checks to ensure that collected data are complete and accurate, and research protocols are being followed in compliance with local IRB policies.

• Participate in weekly PI study meetings and sponsor site monitoring calls.

• Maintain study binders and records related to clinical research studies to ensure compliance with Health Insurance Portability and Accountability Act (HIPPA).

• Compile adverse event AE’s and severe adverse events SAE’s logs and timely reporting to sponsor and protocol data monitoring committee (PRMC) and data safety monitoring committee (DSMC) for quarterly review of study conduct.

• Register patients for clinical trials.

• Extract and examine medical record information using EPIC relevant to the research study to answer queries and specific research questions raised by the sponsor/ Contract Research Organization (CRO).

• Demonstrate understanding and knowledge specific to the protocol, patient information and CRFs, to effectively assist with study execution.

• Adverse Reaction (AE), Serious Adverse Event (SAE) and Adverse Drug Reaction

(ADR) reporting and reconciliation with the source documents.

• Review clinical data on Case Report Forms (CRF) for completeness and accuracy, track and resolve queries.

• Resolved 1500+ data queries in 90 days for MM Celgene Study.

• Designed CRF for Principle Investigator (PI) initiated study (paper CRF).

• Communicate with the sponsor about issues related to the data capture systems and help to optimize and improve the system.

• Improved the quality of research data minimizing the inconsistencies by 98% (zero missing forms, missing values and data anomalies) for 8 months.

• Helped with the Audit to meet requirements in terms of quality of data consistent with source documents.

• Identified and implemented best practice for process improvements (worth $4500 in profit for the organization).

• Review charts for the Audit ensuring elimination of major issues in consent forms.

• Cleaned Data for audit readiness and ensured study data is regulatory compliant at all times. (Successfully managed data for positive outcome of all audits).

• Collaborated in the preparation of audits and inspected and ensured Corrective Action and Preventive Action Plan (CAPA) post audit was presented.

• Improved site performance index (SPI) by implementing and driving performance improvement initiatives like Six Sigma and LEAN.

• Provide support to data management staff for other satellite sites over the duration of study.

• Covered other study sites with cleaning data, regulatory submissions and COV.

• Monitoring of study data, on site visit (IMV) and remote monitoring visits (RMVs).

• Prepared subject data for Biomedical Research Alliance of New York Audit 2021.

• Trained volunteers for work in Clinical Trials Coordination and data entry. Montefiore Medical Center, NY Jan 2017 – Oct 2017

Clinical Research Volunteer

• Coordinate all aspects of the research project with the study team and partners

• Work with principal Investigator (PI) and data managers to securely extract and manage medical record data, and assist with coordination of secure data sharing with study partners consistent with data use agreements and IRB conditions

• Assist in coordinating, managing and analyzing data; perform regular audits to ensure that collected data are complete and accurate, and research protocols are being followed

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• Maintain study binders and records related to clinical research protocol

• Make study calendar to ensure research is carried out consistent with protocols

• Extract and examine medical record information using EPIC relevant to the research study to answer queries specific

• Coordinate, and conduct data collection, data entry into client sites

• Assist in other duties as assigned

CD InfoTech, Andheri, Mumbai May 2016 – Dec 2016

Business Improvement Consultant

• Business improvement and transformation with DMAIC methodology

• Improved customer verification process for IDEA and Vodafone Cellular Network by benchmarking the process and setting checkpoints.

• Mapped the process to analyze gaps and identify potential reasons for issues.

• Achieved 80% Cycle Time (CT) and Turn Around Time (TAT) reduction in the process through various tools of Six Sigma and Lean principles.

• Presented data in MS Excel and its analysis, interpretation, visualization and reporting.

Albert Einstein College of Medicine, Bronx, NY

Summer Volunteer July 2015 – Jan 2016

• Analysis of methylation and hydroxyl methylation in DNA sequence data of Cancer patients using Bioinformatics software and tools

• Study Molecular Biology techniques for mammalian cell culture

• Research documentation and protocols

Freelance Writer/ Editor/ Proofreader/ QA Mar 2014 – Mar 2015

• Technical writing for science publication

• QA science publication, proofread to bring quality to acceptable levels

• Writing protocols and design of experiments

• Editing and formatting science projects and presentations

• Proofreading medical summaries and medical reports Jupiter Hospital, Mumbai, India Jun 2013 – Feb 2014 Medical Records Abstractor/ Transcriber

• Quality check records for errors in progress notes and clinical documentation.

• Worked alongside resident medical officers (RMOs) and physicians to transcribe progress reports, clinical progress reports and discharge summaries of patients

• Abstract important events into a medical record or summary for relevant information such as diagnostic reports, surgical and operative notes, treatment received, medicines administered, and medical procedures performed on patients.

• Guided new joiners for using patient management system and preparing discharge summaries and standard operating procedures.

Health Prime International Ltd., Mumbai, India Apr 2012 – Oct 2012 Medical Records Analyst/ Transcriber

• Transcribed electronic health and medical records (EHR) and (EMR) for US patients using Aprima patient management system

• Delivered reports within specified turn around time and accuracy above 98%

• Maintained quality of reports as per HIPPA, USMM and NIH standards

• Worked on medical and clinical documentation

• Among top 3% of employees with highest accuracy in patient transcribed reports. Page 4 of 6

Bio-Medicines Ltd., New Zealand Nov 2009 – Apr 2011 Pharmacy Assistant (Business Development)

• Answered customer queries and performed administrative tasks

• Received orders from customers (retail shops and health practitioners)

• Managed stocks, inventory, packaging, and dispatch of health supplements

• Worked on Quick Books accounting software to generate invoices, monthly reports

• Managed customer accounts to receive payments in cash and via Credit Cards, PayPal, Epos

• Designed forms, labels, newsletters and fliers for marketing new products

• Managed computer systems: Installed and updated all the software’s

• Product documentation and writing new content for marketing new products B.N.B College of Science, Mumbai, India Jul 2008 – Feb 2009 Teacher (Department of Biology)

• Conducted Zoology practical’s as a demonstrator

• Supervised practical exams as a subject expert

• Published a website for a science research journal Bionanofrontier.

• Edited and managed website content

• Maintained the website and improved the quality to increase traffic to the website with search engine optimization (SEO) like listing the site in various search engines. EDUCATION

Mumbai University Jun 2005 – Apr 2007

Master of Science (Biotechnology)

Mumbai University Jun 2002 – Apr 2005

Bachelor of Science (Botany)

Waikato University, Hamilton, New Zealand Feb 2009 – Apr 2010 Post Graduate Certificate in Science and Technology AUT (Auckland University of Technology), Auckland NZ Jul 2015 – Jul 2016 Certificate in Medical Terminology (Online) Score of 97% (A++) KEY SKILLS

• Attention to details and prioritizing skills

• Strong communication and organizational skills

• Research and analytical skills

• Ability to take initiative and responsibility to deliver quality work

• Ability to work unsupervised as well as in a team

• Business transformation, change management and continuous improvement

• Teaching and mentoring high school and college students

• Medidata Rave, Oracle Inform, ANCHOR EDC, Velos, EPIC, iRIS

• Quality and Process improvement with LEAN and SIX Sigma Page 5 of 6

PROFESSIONAL QUALIFICATION

Advance Diploma in Computer Hardware and Networks Jan 2005 – Jul 2006 Jetking Institute of Computer Education, Mumbai

• PC Assembling, Hardware and Software installations (A+ certified)

• Networking Troubleshooting and Computer Maintenance (N+ certified) PROFESSIONAL CERTIFICATIONS AND TRAININGS

MBA (2020 - Ongoing @UoP) Dec 2022

Certified Business Consultant @ USIDHR Washington, DC Dec 2021 Wharton Business School (Customer Analytics-Online Course) Apr 2019 SAP HRM Introductory Course Feb 2019 – Mar 2019

CCRP from SOCRA (Registered/Ongoing) Feb 2019 – Current Elite Project Management Training for PMP and CAPM Feb 2019 – Current Albert Einstein College of Medicine, NY Jul 2017 – June 2018

• CR101: Clinical Research Methods Lecture Series

• CITI Training HHS and Good Clinical Practice (GCP) National Institute of Health Clinical Center Sep 2017 – June 2018 Introduction to the Principles and Practice of Clinical Research Government. of India Feb 2016

Six Sigma Black Belt Certificate (SSBB)

Process improvement methodology (DMAIC), concept of zero defects, problem-solving techniques, statistical data analysis-using Minitab-16 and Microsoft Excel

University of Pittsburgh USA Apr 2015

Medical Terminology for US and International Students (Online) Alcove Life Sciences, Hyderabad, India Aug 2011

Industrial Training in Bioinformatics:

1. Project Title, “Designing Primer for PHA Synthase using Bioinformatics tools for its application in production of Bio-plastics”. 2. Used “Auto Dock Vina”, which is a computational drug designing tool. It can be used in docking studies to simulate ligand and binding site compatibility. Within minutes, it can predict how the ligand can bind to the binding site, all this without going to the bench doing wet lab study. IELTS Band 7/9 (International English Language Testing Service) Sep 2008 Microsoft Office Suite (Word, Excel, PowerPoint) from NIIT Thane Jun 1997 Scored 80% in UN Information Test at High School Sep 1996 Page 6 of 6

PUBLICATIONS

1. Remdesivir for the Treatment of COVID-19 Mar 2020 – Jun 2020 2. Remdesivir + Baricitinib for the Treatment of COVID-19 Nov 2020 – Apr 2021 3. Lenalidomide + Eltrombopaq for treatment of MDS Nov 2021– Dec 2021 PROFESSIONAL MEMBERSHIPS

• Member of the Quality Council of India Membership No. FM/5198/2017-18

• Indian Society for Clinical Research Member 2019

• Heath Informatics New Zealand Membership Ref. No. ev002000427

• Cancer Epigenetics Society Membership Ref. 1072

• Society for Clinical Research Associates (SOCRA) Member since 2/14/2019

• Healthcare Information and Management Systems Society (HIMSS) Asia Pacific Member since August 24th 2018

• American Association for Cancer Research (AACR) Associate Member Ref No.494912

• Mentor at iMentor Manhattan New York United States of America 2019-2020 CONFERENCES AND WORKSHOPS

• Awarded Scholarship of $ 998 to attend the Health Informatics New Zealand, HiNZ Conference in New Zealand 1-3 Nov 2017.

• International Conference, “Biotechnology for Better Tomorrow 2015”, Tampa, Florida USA on 29-31 Oct 2015 (edited abstracts for the conference).

• Trinet-X Conference for Technological Advances in Clinical Research, Boston, Sep 25th 2019

• FortySeven Inc, investigators meeting, Florida, Dec 6th 2019

• Online virtual digital transformation conference by LiveWorx 8-11 June 2020. VOLUNTEERING

Multiple Myeloma Research Foundation (MMRF) “Road to Victories”, Fundraising Sep 2019 Great Cycle Challenge's efforts to fight kids' Cancer Bike Ride for Fundraising Sep 2020 Volunteer Waikato City Methodist Church, helped special needs students learn Computer Skills (Tutor Aid to Mr. Kaveh Tabrizi), Hamilton New Zealand Nov 2009

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