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Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
Executive Profile
My experience in the clinical lab is extensive and diverse, resulting in over 18 years of experience in academic, government, and commercial/biotechnology laboratory settings. Four of those years were as a generalist, with emphasis in clinical microbiology and hematology and the remaining 14 years were in molecular diagnostics; with over 9 years in management and 5 years as a Translational Clinical Coordinator. I have managed multiple projects and collaborated with cross-functional teams. I am actively involved in the global standardization of clinical molecular testing, assay development, validation, accreditation, and more recently, clinical trial management. I have prepared for and participated in numerous CAP and New York audits and have assisted a clinical laboratory in Germany for the DaKKS audit. I played a key role in the successful transitioning a CAP/CLIA laboratory to an ISO 15189 and GCP/GLP compliant and accredited laboratory. I have successfully designed (to include primer design), developed, optimized PCR based assays (to include NGS), developed, and transitioned them into a clinical molecular diagnostic laboratory. I am a member of a NGS (Next Generation Sequencing) team, to assist in workflow design, optimization and validation of a bioinformatics pipeline. I am assisting with the assembly of an NGS core team and the protocols used to standardize annotation, defining the proper approach to assessing novel somatic mutations, etc. I have established strong working relationships with multiple pharmaceutical companies and assisted with the logistics of implementing and initiating clinical trials in a lab, developing databases, writing protocols, and assisted with writing the providing the supporting technical documentation required for their submission to FDA for targeted molecular therapeutics. I am currently the Lead Study Coordinator for a Phase III clinical trial. I enjoy optimizing, designing and developing assays, building strong collaborations with partners (pharmaceutical, academic, etc.) and ensuring that parties involved will benefit from the project. I enjoy training team members on technical aspects of new assays, project management, clinical studies/research/publications, and the implementation and enforcement of quality systems in a multiple- laboratory system or entity. I have also taken an interest in interacting with external auditors, preparing/performing audits, and assisting with clinical trials. Thank you in advance for your consideration. Best regards, Jessica Claire
Skill Highlights
  • Guest services
  • Inventory control procedures
  • Merchandising expertise
  • Loss prevention
  • Cash register operations
  • Product promotions
Core Accomplishments
Professional Experience
Laboratory Manager and Translational Research and Clinical Coordinator - Director Veena Singh, LabPMM, 01/2009 to Current
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Laboratory Supervisor - Director, 01/2006 to 01/2009
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  • Veterans Administration Medical Center Indianapolis.
  • Indiana University School of Medicine.
Clinical Laboratory Scientist - Director, 01/2000 to 01/2005
Dept. Of Molecular Pathology, ,
Laboratory Section Supervisor (Generalist) - Director Captain Marilyn Brew, 01/1991 to 01/1995
Veterans Administration Medical Center Indianapolis Indiana University School Of MedicineCity, STATE,
  • Lead Clinical Trial Study Coordinator for a Phase III clinical trial.
  • Responsible for the successful transition of a CAP/CLIA laboratory to an ISO 15189 and GLP/GCP accredited and/or compliant laboratory.
  • Currently designing and will implement a clinical database for use in a Phase III pharmaceutical trial.
  • Actively involved in the global harmonization of assay development, assay validation, procedures (when possible), technical competency, and clinical trial management.
  • Prepared and lead CAP, New York, and ISO 15189 audits and assisted in the preparation for DaKKS audits in Germany.
  • Strong writing skills (procedures, journal publications, conference poster presentations, validation reports, abstracts, performance qualifications, CAPAs, etc.).
  • Successful collaborations involving cross-functional teams in an effort to implement, optimize, and validate technologies successfully, comprehensively, and efficiently for use in clinical laboratory setting.
  • Has successfully designed and developed molecular based assays, such as NGS (next generation sequencing), capillary electrophoresis, real-time PCR, etc., to include primer design, optimization, feasibility studies, validation studies, and accreditation (NY and CE-IVD).
  • Currently working with a NGS bioinformatics team to aid in the workflow design, optimization and validation of a bioinformatics pipeline.
  • Contributed to the assembly of the NGS core team and the protocols used to standardize annotation, proper approach to assessing novel somatic mutations, etc.
  • I have established strong working relationships with multiple pharmaceutical companies, assisted with the logistics of testing their samples for clinical trials and providing the supporting technical documentation required for submission to FDA for targeted molecular therapeutics.
  • Implementation and validation of various PCR based assays in the fields of infectious disease, oncology, genetics, and pharmacology.
  • Acquisition of new equipment, cost analysis, IQ/OQ/PQ reports, procedures, training and contract negotiations.
  • Familiar with a Quality Management program that is ISO 15189 compliant and experienced with its implementation in a clinical laboratory setting.
  • Extensive experience with a wide variety of molecular instrumentation to include nucleic acid extraction automation, capillary electrophoresis, real-time PCR, next generation sequencing.
  • Responsible for teaching the clinical molecular diagnostic rotation for Indiana University Pathology Residents.
  • Management Experience: Responsible for the daily operation of the laboratory and team members.
  • Responsible for the adherence to all procedures and ensuring compliance with our Quality Management System (in compliance with 15189 standards).
  • Responsible for audits (in USA and abroad), laboratory and personnel licensing, and continuing education.
  • Clinical Trial management Responsible for training laboratory staff (both in USA and Germany) in all stages of testing and annual competency assessments.
  • Ensures that customer service and support is to the highest standard, which is critical.
  • Writes, revises, and maintains all clinical procedures.
  • Responsible for preparing and submitting all validation documents to New York for approval.
  • Responsible for ensuring that state licenses for the operation of LabPMM are valid and submitting renewals or resubmitting applications if necessary.
  • Proficiency panels: ordering panels annually from agency to ensure new assays currently in development are assessed.
  • For assays that proficiency panels are not available, proficiency is assess by other means.
  • Reviews all Quality events for LabPMM to assess trending, etc.
  • Responsible for scheduling staff vacations, training new employees, and ensuring that the laboratory is adequately staffed.
  • Negotiates instrument service contracts, implements new instrumentation and writes SOPs, drafts validation plans and validation summaries.
  • Leadership Qualities and Experience: Demonstrated leader, thrives on promoting team work in the workplace.
  • Focuses team on setting/accomplishing high and obtainable goals.
  • Encourages members to "think outside the box" to improve aspects of customer service, problem solving, and efficiency, when appropriate.
  • Successful at building highly motivated and productive teams.
  • Recognizes the strengths in each individual member and uses those strengths to the benefit of the group.
  • Makes an effort to empower team members to accomplish their personal and professional goals.
  • Recognizes the importance of leading by example.
Education
B.S: Clinical Laboratory Science Medical Technology, Expected in
Indiana University - Indianapolis, IN
GPA:
Clinical Laboratory Science Medical Technology
Molecular Pathology American Society for Clinical Pathology (MP ASCP) certified (ID # 04158378) California State certified: Clinical Genetic Molecular Biologist Scientist (ID# MTP00000269) In-vitro Diagnostic Product Development (UCSD course# 104540): , Expected in
- ,
GPA:
Interests
Hobbies include running, hiking, reading, painting, and writing.
Publications
Pier Review Articles Dunphy CH, O'Malley DP, Cheng L, Claire TY, Perkins SL: Primary mediasJessical B-cell lymphoma: Detection of bcl-2 gene rearrangments by polymerase chain reaction (PCR) analysis. Presented at the 2006 annual meeting of the United States and Canadian Academy of Pathology in San Atlanta, Georgia. Mod Pathol 2006; 19 (Suppl 1):1037A. Text Book Chapters Parks J, Claire TY, Zhang S, Cheng L: Chapter 24. Molecular Hemoglobinopathies. In Cheng L, Zhang DY (eds) Molecular Genetic Pathology. Page 633-650, Humana Press/Springer, Totowa, NJ, 2008. Claire T, Zhang S, Cheng L: Diagnostic Applications of a Nested Polymerase Chain Reaction Assay for the Detection of Cytomegalovirus. In Czader M (eds) Molecular Genetic Pathology Protocols. In progress. Presentations at meetings Poster Presentation, Veterans Affairs National MRSA Conference, MRSA PCR Testing: Cost Effective and Includes DNA Extraction; Orlando, FL, October 2007. Poster Presentation, Association of Molecular Pathology, Improved Efficiency and Cost Reduction for MRSA Detection Using Roche PCR Platform; Grapevine, TX, October 2008. Oral Presentation, South Central Association of Clinical Microbiology "MRSA Milestones", Indianapolis, Indiana, March 20, 2009. Poster Presentation, Association of Molecular Pathology, Characterization of FLT3 ITD Mutations in 1,711 Clinical Samples Identified by Testing 9,836 AML Samples; Grapevine, TX, October 2012.
Additional Information
  • Personal Interests: Hobbies include running, hiking, reading, painting, and writing.
Skills
acid, approach, assembly, agency, automation, contract negotiations, contracts, cost analysis, customer service, database, designing, Product Development, feasibility studies, functional, GCP, GLP, IQ, ISO, Leadership, logistics, next, novel, optimization, OQ, PCR, personnel, PQ, presentations, problem solving, protocols, publications, Quality, Quality Management, real-time, scheduling, teaching, team work, technical documentation, validation, workflow, Strong writing skills

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Resume Overview

School Attended

  • Indiana University

Job Titles Held:

  • Laboratory Manager and Translational Research and Clinical Coordinator - Director Veena Singh, LabPMM
  • Laboratory Supervisor - Director
  • Clinical Laboratory Scientist - Director
  • Laboratory Section Supervisor (Generalist) - Director Captain Marilyn Brew

Degrees

  • B.S
  • Molecular Pathology American Society for Clinical Pathology (MP ASCP) certified (ID # 04158378) California State certified: Clinical Genetic Molecular Biologist Scientist (ID# MTP00000269) In-vitro Diagnostic Product Development (UCSD course# 104540)

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