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Yyyyyy x. yyyyyy
0000 xxxxxx xxxx , xxxx , xxxxx 00000 ~ 209.207.4459 ~ abc@xyz.com
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
Trial Master File Specialist, BioMarin, San Rafael, CA 2017
For this specialized assignment/project, diligently reviewed and uploaded documents, performed any needed correction and completion of metadata, and conducted QA of documents in Veeva Vault eTMF and hard copies.
Continually ensured that records management/CROs were kept apprised of any changes/corrections to documents following in-depth assessment/review.
Regularly performed site file reviews and developed/completed review checklists and quality check trackers; also collaborated cross-functionally with team leads/members in designing/maintaining multiple trackers.
Selected to participate in team meetings and presented updates on Trial Master File (TMF) status; worked closely with CRO personnel and produced/disseminated multiple TMF reports.
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
Yyyyyy x. yyyyyy Page 2
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
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
Education
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
Honors/Awards
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, 1998-200)
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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