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Yyyyyy x. yyyyyy 0000 xxxxxx xxxx , xxxx , xxxxx 00000



Medical professional, with advanced education and extensive practical experience,

seeking a Full-Time assignment as a

Clinical Research Specialist


Profile of Qualifications


  Doctor of Medicine

  Masters in Education, Technology and Outreach Education

  B.A., Molecular Cell Biology

  Six Sigma Master Black Belt course work

  Over 13 years of progressively responsible research and project experience

  Extensive awards/certifications

  CRA Certification courses

  Knowledgeable in drug development, clinical trials, medical reviews and scientific data interpretation


Areas of Expertise

ICH/GCP ~ ARIS, ARISg ~ Study Qualifications/Protocols ~ Clinical Trials ~ Regulatory Compliance ~ Scheduling ~ Project Management ~ Drug Safety ~ Scientific Editing/Publishing ~ Instructor/Curriculum Developer ~ GCP, ICH, FDA, EU ~ Narrative Writing ~ CTMS ~ RAD Microsoft Outlook


Professional Synopsis



Senior Clinical Research Associate

The Clinical Excellence Research Center/Stanford University 2006 2012, 2014, 2017- Present

       Expertly oversee Trial Master Files and other research documentation and develop regulatory binders; perform clinical trial data/adverse events review, study protocols and develop clinical study reports, ICFs, CRFs, PSURS, ICSRs and outcome fact sheets

       Manage supply shipments, design/maintain trackers and ensure compliance with DOT, IATA and other relevant entity regulations; scrupulously inspect clinical trial supplies upon receipt to ensure products meet highest quality levels

       Skillfully fulfill ICFH/GCP compliance guidelines for sponsor-organizations Pfizer and Eli Lilly

       Author SOPs, regulatory submissions, clinical trial summaries and investigator brochures, administer scheduling, tracking and IRB/EC approvals, and facilitate ARIS/ARISg data entry and narrative production

       Successfully evaluate medical conditions, laboratory results and clinical trial data reviews; manage site activation checklists, perform document review and serve in liaison role between multiple departments


Clinical Research Specialist, Medtronic, Santa Rosa, CA 2016- 2017

       Met comprehensive responsibilities for reviewing Site Activation Documents, GO Letters and staff readiness documentation, and assured completion of Site Readiness checklists

       Effectively monitored array of devices, uploaded end-of-use report data into trackers and developed/maintained multiple trackers; tracked action items and served in liaison/communication role between Field monitors, study staff and in-house staff

       Adroitly managed schedules for/tracked such activities as enrollment meetings, calibration due dates, processing of ICON user requests, reviewing Site Files and filing both electronic and hard-copy TMFs

       Produced monitoring reports, maintained inventory/shipping supplies, updated trackers, drafted meeting minutes and conducted Audit Trail follow-up


Clinical Trial Assistant, InClin, San Mateo, CA 2015

         In this assignment, diligently organized/maintained Trial Master Files for multiple studies; developed individual binders covering regulatory requirements, pharmacy issues and other trial-related information

         Facilitated Site Activation and ensured strong study communication, serving in liaison role between departments; uploaded relevant data/study details in Simple CTMS

         Recorded minutes of meetings, compiled all relevant meeting notes and oversaw organization of meeting details

         Designed/maintained trackers and ensured compliance with ICH/GCP, DOT, IATA and other prevailing regulations

Yyyyyy x. yyyyyy Page 2


Tutor (K-12) Math, Reading, Writing, Science, Sylvan Learning Center, Pleasanton, CA 2012 - Present

         Utilize subject matter expertise as well as strong instructional capabilities in teaching multiple subjects to youngsters


Clinical Safety Associate, Genentech, South San Francisco, CA 2013

       Retained to manage safety concepts according to ICH and FDA guidelines

       Completed ICSR report review and isolated case-pertinent clinical information

       Designated for Study Management Teams, gained expertise in safety exchange agreements and prioritized work to ensure regulatory compliance


Wellness Letter Editorial Board, University of California, Berkeley, CA 2011 2012

       Contracted to provide editing, publishing and development of monthly scientific/health newsletter covering biology, molecular biology, psychiatry and personal health

       Acted as Medical Writing Consultant developing clinical study documents, WPDs, ICSRs, PSURs and SOPs


Earlier, served UC Berkeley as Program Representative/Instructor, Stanford University as

Biomedical Ethics Intern and Lawrence Berkeley National Laboratory as Research Associate




Touro School of Medicine, Doctor of Medicine, 2010


University of San Francisco, Master of Arts, Education Technology & Outreach Education, 2004

Honors Graduate


University of California, Berkeley, Bachelor of Arts, Molecular Cell Biology, 2002

Honors Graduate




  Harvard School of Medicine Diversity and Community Partnership Visiting Academic Scholarship, 2009/2010

  Special selection as sole participant to conduct presentation on Cardiovascular Disease Prevention Education at the Annual National American Academy of Pediatrics National Convention in Atlanta, Georgia

  Arnold P. Gold Foundation Humanism in Medicine Medical Student Research Project Community Scholarship

  California Association of Family Physicians Community Research Grant (2006, 2008)

  TUCOM Dean s List

  University of San Francisco Dean s Merit Scholarship, 2004

  UC Berkeley Outstanding Honors Research Project Presentation Award, 2002

  LifeScan Johnson and Johnson Outstanding U.S Citizen Scholar (1998-2002)

  UC Berkeley Biology Fellows Program Howard Hughes Medical Institute Research and Project presentation scholarship

  UC Berkeley Dean s List

  National Science Scholar of the Congressional District

  High Honors in the Golden State Exams for Biology, Algebra, Geometry and U.S History

  Xerox Award for Excellence in the Humanities and Social Sciences

  Valedictorian Livermore High School, Livermore, CA


Professional Affiliations


Member American Academy of Pharmacologists

Member American Medical Association (AMA)

Member American Academy of Cardiology and Preventive Medicine

Member American Academy of Pediatrics

Volunteer Livermore Veterans Hospital, Livermore, CA (1992- Present)

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