Laboratory Technician III, Laboratory Technician IV, Technical Associate Resume Example University Of Rochester

LABORATORY TECHNICIAN III, LABORATORY TECHNICIAN IV, TECHNICAL ASSOCIATE

Experience

01/2014 - Current

University of Rochester － Rochester, NYLaboratory Technician III, Laboratory Technician IV, Technical AssociateReporting to Principal Investigators, and with latitude for exercise of independent judgment and initiative, has direct responsibility for implementing a diverse portfolio of research activities for multiple studies including industry-sponsored and local investigator-initiated clinical trials. (RegiSONIC ML 28296, VISMOHS ML 28726, Pioglitazone effect on SCC RSRB 00052209) Acts as liaison with WIRB, sponsor's Clinical Research Organization (CRO), Central Labs, and other departments within URMC to ensure thorough understanding and communication, and to respond to questions that arise during the study. Maintains an excellent working knowledge of FDA, WIRB, and RSRB compliance as it relates to the specific tasks of coordinating a study to attending investigator's meetings and interacting with study sponsors. Supervises and trains clinical staff to ensure study operations are compliant with URMC, government, and sponsor's regulations. Reviews with Principal Investigator and clinical staff appropriate data safety and monitoring procedures, including the various RSRB/WIRB requirements regarding subject safety, data management, and confidentiality. Oversees the documentation and tracking of specifics processes that each study adheres to and maintains a detailed log of all activities. Requests clinical budget and contract documents from sponsors and CROs. Requests quotes from subcontractors. Reviews clinical trial protocols and develops preliminary and final budgets and URMC pre/post award notebooks for presentation to Principal Investigator, URMC auditors and sponsors. Initiates and leads budget negotiations with CROs. Performs final accuracy review of contractual documents on a highly time-sensitive basis and coordinates the signature process. Organizes and plans project start-up including applying for RSRB, WIRB, URMC Clinical Research Center and other ancillary approvals. Designs and writes source documents and databases utilizing REDCap, Excel and Word. Prepares documents for study sponsor and regulatory agencies including RSRB, WIRB and FDA. Writes informed consent forms, consent form revisions, and assures the University mandated language related to injury and indemnification, confidentiality and HIPAA authorizations is included as required. Manages infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation working with Principle Investigators to ensure proper execution of studies. Determines possible research study candidates by reviewing medical records and consulting with physicians. Determines eligible research study candidates through careful review of protocol and inclusion/exclusion criteria. Coordinates appointments and correspondence with all subjects enrolled in research studies. Requests medical records from outside sources. Reviews medical records for information as needed. Transmits medical records or research documents according to HIPAA guidelines and according to research protocol instructions. Prepares supply of patient-ready packets per protocol, as needed. Responsible for accurate and timely transcription of study data for each research subject to paper and/or electronic Case Report Forms (CRF) retrieving information from electronic or paper medical record including past medical history, demographics, concomitant medications and adverse/serious adverse events. Maintains proficiency utilizing electronic Data Capture Systems including REDCap, Medidata, InForm, and Firecrest. Communicates with CRO in a timely manner to clarify data queries. Responsible for coordinating the blood and tissue sample collection and shipment by acting as liaison between the URMC Clinical Research Center, University of Rochester Clinical Trials Processing Lab and Central Laboratories. Develops and maintains a processing and tracking system for all pharmacokinetic, safety lab tests, and screening lab tests required by study protocol. Responsible for drug accountability using IxRS system and maintains temperature logs. Using knowledge of Good Clinical Practice standards, prepares and collates subject study information in subject study binders. Maintains regulatory binders to ensure compliance with FDA, sponsor, and RSRB/WIRB SOPs and guidelines. Maintains communication with monitors and sponsors regarding the status of subjects at our site. Reports protocol violations, adverse or serious adverse events and reviews to sponsor, CRO, and WIRB in a timely manner. Reviews sponsor, monitor and regulatory correspondence for accuracy. Prepares and schedules study monitoring visits conducted by independent medical monitors. Completes necessary corrections to study documents revealed by Medical Monitor or Clinical Research Associate proficiently and in a timely manner. September 2001 - Present Supervise and teach students and technicians to design and implement research projects in a Cancer Research Laboratory utilizing specific laboratory techniques: * DNA purification/quantification, subcloning, sequencing * Genotyping, PCR, RT-PCR, Real-Time PCR * Protein purification/quantification, Western Blotting, Zymography * Tissue Culture, ELISA, Immunohistochemistry, Laser Capture Microdissection

09/2000 - 06/2001

Honeoye Central School － Honeoye, NYRegents Biology/Physical Science Teacher* Developed inquiry based lessons to develop critical thinking skills * Provided "hands on" laboratory sessions to enhance student learning * Member of the Cornell Institute for Biology Teachers

09/1999 - 06/2000

Unadilla Valley Central School － South New Berlin, NYLife Science/Technology Teacher* Developed inquiry based lessons to develop critical thinking skills * Provided "hands on" laboratory lessons to enhance student learning * Collaborated with grade level teachers to effectively teach Interdisciplinary Projects * Utilized motivational techniques to encourage success of "at risk" students

08/1987 - 08/1996

Mogen David Wine Company － Westfield, NYQuality Control Technician* Trained and supervised Quality Control Technicians * Supervised grape crush laboratory * Supervised production line sanitation and startup * Solved quality control problems * Wrote handbook of laboratory methods and standard operating procedures * Maintained government records Ordered and maintained chemicals and laboratory equipment * Performed microbiological testing * Performed specialized chemical test for sorbate, citrate, invert sugar, ash and carbon dioxide * Performed raw materials testing * Measured volume, temperature and torque of products * Performed Brix, total acid, volatile acid, free sulfur, total, sulfur, and alcohol tests * Maintained records

Education

State University of New York College at FredoniaBachelor of Science: Biology/Secondary Education, ChemistryState University of New York College at Fredonia Bachelor of Science, Biology Certification, May 1999 Major - Biology/Secondary Education, Concentration - Chemistry Biology Course Work - Principles of Biology 1&2, Animal Behavior, Zoology, Botany, Molecular/Cell Biology, Genetics, Ecology, Senior Seminar, Microbiology, Biochemistry, Human Anatomy & Physiology, Gross Anatomy and Pathophysiology

Professional Affiliations

of the Cornell Institute for Biology Teachers

Accomplishments

Requests clinical budget and contract documents from sponsors and CROs. Requests quotes from subcontractors. Reviews clinical trial protocols and develops preliminary and final budgets and URMC pre/post award notebooks for presentation to Principal Investigator, URMC auditors and sponsors. Initiates and leads budget negotiations with CROs. Performs final accuracy review of contractual documents on a highly time-sensitive basis and coordinates the signature process

Certifications

HIPAA Clinical Research Associate Laboratory Technician RT Bachelor of Science, Biology Certification

Skills

Laboratory, Associate, Dna, Elisa, Fermentation, Genotyping, Laboratory Technician, Laser, Pcr, Protein Purification, Purification, Real-time, Sequencing, Tissue Culture, Western Blotting, Quality Control, Carbon Dioxide, Equipment Sales, Laboratory Equipment, Materials Testing, Microbiological, Production Line, Raw Materials Testing, Sanitation, Testing, Award, Basis, Budget, Budgets, Case Report, Case Report Forms, Clarify, Clinical Research, Clinical Trial, Clinical Trials, Collection, Conditional Random Field, Correspondence, Crf, Cro, Data Management, Database, Database Management, Databases, Documentation, Excel, Fda, Hipaa, Leads, Liaison, Medical Records, Operations, Pharmacokinetic, Procurement, Sops, Space Allocation, Study Monitoring, Transcription, Word, Life Science, Brix, Biochemistry, Cell Biology, Chemistry, Microbiology, Zoology

Resume Overview

Companies Worked For:

University of Rochester
Honeoye Central School
Unadilla Valley Central School
Mogen David Wine Company

School Attended

State University of New York College at Fredonia

Job Titles Held:

Laboratory Technician III, Laboratory Technician IV, Technical Associate
Regents Biology/Physical Science Teacher
Life Science/Technology Teacher
Quality Control Technician

Degrees

Bachelor of Science : Biology/Secondary Education, Chemistry

Laboratory Technician III, Laboratory Technician IV, Technical Associate Resume Example

Resume Score: 100%

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