Magalie Collet
Senior Clinical Data Specialist at The Jackson Laboratory- Claim this Profile
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French Native or bilingual proficiency
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English Full professional proficiency
Topline Score
Bio
Credentials
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Clinical Research Assistant Development and Education Certificate
PharmaSchoolNov, 2013- Nov, 2024
Experience
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The Jackson Laboratory
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United States
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Biotechnology Research
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700 & Above Employee
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Senior Clinical Data Specialist
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Mar 2022 - Present
Responsible for coordination, administration and compliance in access requests, use and sharing of clinical and genomic human datasets.*Managerial position*Data access coordinator between the investigators, the CTRS and IRB offices, the office of General Counsel, IT Security, Research IT and Sponsored Research Administration for requests to the NIH repository dbGaP and worldwide Data Use Agreements.*Provides access requirements screening, project review, quality assurance, regulatory documents review, internal IRB/ethics submissions, project management of the requests across many departments.*Facilitates amendments, renewals, transfers of data projects and associated IRB/ethics submissions.*Review of DTA to external parties: review of informed consent choices, protocols, agreements.*Human data sharing/upload facilitator for Federally and non-federally funded research projects and collaborations: coordination, review of grant data sharing plans, respect of informed consents from participants, quality control/curation of the clinical research data to ensure de-identification, completion of regulatory and administrative documentations and upload of metadata templates to dbGaP, EGA, SRA, GEO and NIAID Import.*Development of workflows and integration to streamline and automate processes between 3 departments*Softwares= IRBManager, ServiceNow, InfoEd user, REDCap. Show less
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Clinical Data Specialist
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Jul 2019 - Apr 2022
*Data access facilitator: dbGaP, Data Use Agreement , Data Transfer Agreement liaison to facilitate the investigators' requests to access Human controlled access datasets (clinical, genomic). -Provide quality assurance with data use agreement screenings/reviews to make sure that coded/de-identified/anonymized/pseudomized data sharing is allowed per consent form/protocol.-Review of DTA to internal/external parties: review of informed consent choices, protocols, agreements.-Work with the IRB office, Legal, SRA, IT Security and provision teams. GDPR knowledge.-Facilitate IRB submissions, annual follow up, amendments, closures.*Human Data upload facilitator for Federally or non-federally funded research projects: -Coordination, review and quality control of the research data : institutional certification, review of the participants consent choices, de-identification of the data per the Safe Harbor method, submission of study configuration documents or agreements and metadata templates. Platforms used: dbGaP, EGA, SRA, GEO, Immport (general knowledge).*Development of a Data Access Request platform using IRBManager web-based software to :-Build easy data access request forms for the investigators.-Streamline our internal data review workflow for 5 departments (CTRS/IRB, Office of General Counsel, Sponsored Research Administration, IT Security, Research IT).-Centralize all internal data access requests (dbGaP, Data agreements).-Easy management of all data projects (new, renewals, amendments, closures, transfers).-Compliance: list of internal approved users to limit access, list of data use limitations, storage location and agreements.*Design, development, validation and support of REDCap database to collect and retain clinical information in eCase Report Forms. Export of data and QC. REDCap administrator role. Show less
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Clinical Research & Data Coordinator
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Jan 2018 - Jul 2019
*Clinical coordination and administration:Recruitment and coordination of research subjects for internal clinical research studies: recordkeeping, schedules, appointments. Ensure that study protocols and regulatory documents are obtained and logged for each project. Perform data collection, entry and maintenance ensuring compliance with regulations and internal and external policies governing data management and data systems.Use of IRBManager and REDCap.*Development, support and validation of clinical research database to collect and retain clinical information in eCase Report Forms using REDCap. Clinical data entry of eCRF on REDCap, Clinical data exports and quality control.*Development of Data Access and IRB forms using the IRBManager web-based software and submission of internal forms for the investigators.*Data access facilitator to facilitate the investigators' requests to access Human controlled access data from the NIH database dbGaP. Provide quality assurance with research application and agreement reviews.Facilitate IRB submissions, annual follow up, amendments, closure. Work with the IRB office, Sponsored Research Administration and IT Security. Show less
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Laboratory Manager/ Research Assistant III
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Jan 2016 - Dec 2017
Subject: LncRNA targeting Lab goal: Our specific focus is on altering the function of specific cell types that control immune responses to allergens, including immune cells known as T helper cells and the epithelial cells that line the airway, allowing accurate and early diagnosis of Asthma disease.My projects focus more on identification of novel LncRNA targets in Dendritic Cells and screening for functions using silencing methods.Laboratory technics:*Immunology: Cell isolation from Human peripheral blood and cell sorting, cell culture BSL2 level, cell differentiation, transfection/transduction of primary cells and cell line... Cell differentiation of Cord blood and Bone Marrow derived Human Eosinophils, Type 2 T cells from Naïve sorted T cells, Mice Bone Marrow derived Dendritic cells.*Molecular Biology: RNA/DNA extraction, PCR, qPCR, mice genotyping, sample preparation for RNA-seq/ ATAC-seq/ ChIP-seq, bacteria work with cloning, CRISPR Cas9, shRNA silencing with gRNAs...*Instruments: Flow Cytometry acquisition and analysis (Canto 2,3; LSRII, Fortessa, Sony SP6800), CyTOF preparation and analysis (Helios)).*My responsibilities as Lab Manager include: creating SOPs and budgets for grants submissions, ensuring staff compliance and bio-safety, lab trainings, ordering lab supplies.*Part of the Safety Committee at JAX. Show less
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Research Assistant II
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May 2014 - Jan 2016
Laboratory technics:*Immunology: Cell culture BSL2 level, cell isolation from Human peripheral blood and preparation for cell sorting, cell differentiation, transfection/transduction of primary cells and cell linesMolecular Biology: RNA/DNA extraction, PCR, qPCR, sample preparation for RNA-seq/ ATAC-seq/ ChIP-seq*Instruments: Flow Cytometry acquisition and analysis (Canto 2,3; LSRII, Fortessa, Sony), CyTOF preparation and analysis (Helios)).Biological and Data management: generation of SOPs, development of a master sheet for tracking collection of samples. Show less
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Baylor Scott & White Health
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United States
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Hospitals and Health Care
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700 & Above Employee
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Research Assistant II
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Jan 2012 - Apr 2014
1/Characterization of type 2 Innate Lymphoid Cells in Human Blood. Isolation of ILC2 in peripheral blood/cord blood/bone marrow: proliferation assay with different cytokines culture conditions and characterization of specific genes and surface markers. Techniques: short/long term cell culture, Flow cytometry 12 colors (Canto 2, LSRII, Fortessa), RNA extraction, RT PCR, qPCR, micro array analysis. 2/ Clinical study with Breast Cancer patients: Blood and tumor processing for flow cytometry analysis. Show less
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UT Southwestern Medical Center
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United States
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Hospitals and Health Care
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700 & Above Employee
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Internship
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Mar 2011 - Aug 2011
Mice study of the spleen and heart development under control of transcription factor Tcf21: cellular localisation and comparaison of Tcf21 mutation at various stages (E10.5-P3) Techniques: mice pups and organs isolation, OCT/paraffin embedded tissue section on microtome, PCR genotyping, immunohistochemistry... Mice study of the spleen and heart development under control of transcription factor Tcf21: cellular localisation and comparaison of Tcf21 mutation at various stages (E10.5-P3) Techniques: mice pups and organs isolation, OCT/paraffin embedded tissue section on microtome, PCR genotyping, immunohistochemistry...
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Institut Pasteur
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France
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Research Services
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700 & Above Employee
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Internship
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Jun 2010 - Aug 2010
Study of the receptor TLR9 in the activation of the dendritic and B cells by parasitic Leishmania DNA. Techniques : Cell culture, flow cytometry, PCR, Western blot, ELISA... Study of the receptor TLR9 in the activation of the dendritic and B cells by parasitic Leishmania DNA. Techniques : Cell culture, flow cytometry, PCR, Western blot, ELISA...
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Education
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2018 - 2018
Northwestern University
Clinical Research Coordinator Training, Clinical Research -
2013 - 2013
PharmaSchool
CRA Development and Education Certificate, Clinical Trials -
2011 - 2012
Pierre and Marie Curie University
Master 2, Research & Development in Biotechnologies -
2010 - 2011
Pierre and Marie Curie University
Master 1, Molecular and Cellular Biology specialized in Immunology, Development &Cancer -
2006 - 2009
Université Pierre et Marie Curie (Paris VI)
Bachelor of biology, Bachelor's degree; Neurobiology, Life Science; Genetic and Molecular Biology; Biochemistry -
2005 - 2006
Paris-Sud University (Paris XI)
Bachelor year 1, Biology, General
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