E. Annette H.

E. Annette H. Email and Phone Number

Site Management Associate @ ICON plc, Clinical Trials Research;QM-IAOCR: Internationally Qualified TMF Manager (Reg: 9773967|23Aug2022);Q-IAOCR: Internationally Qualified TMF Associate (Reg: 9773967|16Aug2022) @ ICON plc
E. Annette H.'s Location
Durham, North Carolina, United States, United States
About E. Annette H.

Summary of Qualifications: Over 20+ years’ experience in Health organization clinical laboratories, the Pharmaceutical Industry and as well in Educational Institution Scientific Research. Approximately 10 years of experience in a Clinical Research Organization (CRO) as a Global Project Specialist and Project Research Associate (study phases I - IV).KEYWORDS:Subsequent Education: Computer-based Trainings and Certifications, Coursework (listed in certification section); General: Time management, Effective communication, Teamwork, Stress management, Problem-solving, Productivity & organization, Critical thinking, Adaptability, Product knowledge, Cloud networking and file sharing, Data Entry; Trading: ETFs (Exchange-Traded Funds), Forex, Futures, treasury, assets, audit, bid/ask, bonds, risk management (reward/risk/ratio), securities, stock, trade (income or wealth), technical analysis, TradeStation, Oanda, Career: 21 CFR, Site Start Up, CDA (Confidentiality Agreement), FQ (Feasibility Questionnaire), TMF, eTMF, ACM-Pivotal Labstar system, Merrill Brink iTrac, Crystal Report Query, Regulatory Affairs, Biochemical Assay, Comet Assay, Komet Image Analysis, Fluorescent Staining, SCGE, Tissue Culture, Statistical analysis (Statmost), Data Management, Data Entry, Histology, Fixation, Processing, Embedding, Microtoming, Staining , Decalcification, Microtome, Cryostat, Necropsy, Phlebotomy, Clinical Chemistry Laboratory procedures, Enzyme Handling, DNA Restriction Enzyme Analysis, DNA Blots, Cell Cycle Regulation, Molecular Biology techniques, PCR, Sequencing, cDNA synthesis, plating and screening of cDNA libraries, plaque purification of positive clones, Cloning with Plasmid vectors, PAGE, Agarose/Acrylamide electrophoresis, DNA extraction, Plasmid DNA preparation/purification, Northern Blot, Western Blot, Autoradiography, Column chromatography, ultracentrifugation, Random primed DNA labeling- radioactive DNA probes, microdialysis and HPLC, Immunocytochemistry, Lab Set-up, Maintained radionucleotide records, Lab Information System-LISCOMPUTER Skills/Electronic Document Management Experience:CTMS (IMPACT/ProjecTrend), Plainview, Workspace Administrator for Shared Workspaces (TeamShare, ProjectPoint, Quickplace), CDMS/CDM (e.g. RDE/EDC -Medidata Rave, OCRDC), eTMF (ORACLE-based indexing system (CDITS), PharmaReady, TransPerfect Trial Interactive), United Language Group, Inc. (formerly Merrill Brink) iTrac system, ACM-Pivotal Labstar system, ORACLE-based indexing system (CDITS)Microsoft Office, Adobe Acrobat, and WebEx Conferencing

E. Annette H.'s Current Company Details
ICON plc

Icon Plc

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Site Management Associate @ ICON plc, Clinical Trials Research;QM-IAOCR: Internationally Qualified TMF Manager (Reg: 9773967|23Aug2022);Q-IAOCR: Internationally Qualified TMF Associate (Reg: 9773967|16Aug2022)
E. Annette H. Work Experience Details
  • Icon Plc
    Site Management Associate 1 (Inclusive Of Etmf/Trial Master File)
    Icon Plc Jun 2021 - Present
    Dublin, Ie
    • Sets up, maintains site-related data in applicable clinical systems e.g. CTMS/PSO, EDC, TMF systems, etc. according to guidelines, procedures.• Serves as primary site contact for study, site management responsibilities including addressing question, inclusive of protocol questions, managing study supplies.• Ensures prompt, complete data entry by sites. Performs data reviews inclusive of site level data review, query resolution, facilitates dB (database) closure and freezing procedures per study plans.• Performs risk assessments, management responsibilities throughout the project including site process evaluation, addressing follow-up items, and escalation of issues.• Ensures compliance with applicable guidelines including ICH-GCP, Company and Sponsor SOPs, project plans, study-specific processes, and local regulations.• Track documents and submissions in CTMS/PSO.• Assist multiple studies migrated from NextDocs to Phlexeview eTMF with updating metadata by amending doc descriptions, linking site personnel, sub-artifact changes, dates, and other ad-hoc updates required.• Utilizes Sponsor TMF systems, mainly Veeva Vault TMF (multiple accounts) and PhlexTMF.• Enters site communications, site visit info, documentation, subject information into required CTMS/PSO.• Apply the SVTs to the site and subjects as appropriate in CTMS/PSO.• Obtains required reporting documentation from various reporting systems (e.g. PSO, Tableau, and/or BI Publisher) as required.• Review Tableau Site Mgmt Dashboard, resolves open Follow-up AIs.• Requests accesses to various vendors (e.g. Medidata, Clario, Eurofins, PPD, Invitae, Signant Health, etc.) for study team, sites and site staff as required.• Function as POC entering all access requests in BioClinica SURE for IRT for study team, sites, and site staff.• Releases site shipments of study materials from printer prior to site activations. • Releases Sponsor/CRO review approvals for document reviews conducted by Advarra IRB.
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  • Beacon Hill Pharma
    Tmf Specialist, Prahs (Inclusive Of Etmf/Trial Master File)
    Beacon Hill Pharma Mar 2021 - Jun 2021
    • Process or review study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific electronic TMF Plans including TMF Specifications.• Supports the life-cycle management and associated processes from study set-up to archiving of the Trial Master File (TMF) according to clinical standards, practices and regulations.• Reviews documents for key identification attributes and, if required, edits and communicates adjustments to data.• Ensures files are thorough and complete through the maintenance of the study folders, application of study-specific labels, assessment of supply needs for each aligned project and review of content compliance.• Interprets TMF specifications on proper disposition of documents. Assists with special projects related to the TMF such as file location organization, archived study maintenance, etc.• Extensive knowledge and application of ALCOA+ standards, GCP, GDP and ICH guidelines (E6(R2)).• SME knowledge of clinical trial documentation, TMF Reference Model, clinical trial activities and related terminology.• Knowledge of Study or Trial, Country and Site level documentation including essential documents.• Ability to navigate eTMF system or eDMS and show advance proficiency with Window Office tools.• Remediation of Internal Review findings including updating eTMF metadata and lifecycle status to assist project team.
  • None
    Job Search And Sabbatical (No Employment)
    None Mar 2017 - Mar 2021
    • Personal/Family, Academic/Education, Art, Volunteering, Languages and Self-Employment (e.g. providing computer assistance to elderly, Freelance Graphic Designer, MLM (NewAge/Ariix, LegalShield)), etc.o Expanding or learning additional skills of interest via computer-based trainings, e.g. IT Management, trading markets, data science, and coding/programming (multiple sources) during time from employment to acquire new skills.(Online Learning: Alison, Stack Skills, Unlock Academy, W3Schools, Codecademy, DataCamp, Khan Academy, Excel with Business, Brainbench (Services ended 31Aug2022; removed certifications), GCF Learn Free, etc.).o Updating expired certifications to maintain knowledge and skills (prior and current).o Interested in learning additional languages (Renew/refresh Spanish (HS & Coll) and begin to learn perhaps Chinese, Korean, and or Japanese).o Laid-off March 2017 and searching for employment more since 2019 passing of ill parent (JUN2018-MAY2019).o Re-employed MAR2021 but plan to always continue learning and maintaining updated and new certifications.
  • Inc Research
    Global Proj. Spec. Ii, Gen Med, Women’S Health, Infectious & Rare Diseases (Etmf/Trial Master File)
    Inc Research Aug 2007 - Mar 2017
    Raleigh, North Carolina, Us
    • Supported Project Management to ensure contracted services and expectations of clinical study were carried out by the assigned project team in accordance with the executed contract and Customer’s expectations. • Tracked & analyzed project details and maintains internal systems for assigned projects within a therapeutic area. Additionally, utilized external vendor systems for project specific needs e.g. Merrill Brink iTrac, now ULG for submission of docs for translation.• Assured compliance with local regulations, Code of Federal Regulations/International Conference of Harmonization (ICH), Good Clinical Practices (GCP) guidelines, and Company and Sponsor Standard Operating Procedures (SOPs).• Project Administration - Utilized designated clinical trial management system (CTMS) to track & process clinical trial information, (e.g., regulatory docs, enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, supplies, IRB re-approvals, data queries) to provide analysis of information to PM.• Processed & tracked vendor invoices, site invoices, & investigator grants payments on assigned projects. Supported PM with initiating requests to Finance Department to generate customer invoices for project labor & expenses.• Oversaw regulatory documentation according to Essential Document Regulatory Guidelines (EDRG) & Trial Master File (TMF) Plan. Conducted secondary review of Essential Regulatory Documents. Served as project representative for internal and external TMF audits. Served as in-house site contact for collection of non-essential regulatory docs, tracking and maintaining drug/study supplies, query resolution, administrative protocol and study related questions.• Reporting - Recorded status of KPIs in assigned systems, with input and oversight from the assigned PM. Assessed & communicated KPIs for associated job tasks to PM with proposed action plan.• Prepared & provided status reports to customers with oversight from assigned PM.
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  • Clinforce
    Clinforce Associate/Indexer (Inclusive Of Etmf/Trial Master File)
    Clinforce Jan 2007 - Jul 2007
    Rtp, Nc, Us
    Outsourcing Group for Schering-Plough Corporation (now Merck effective 2009)•Identified documents or documentation submitted to the central file, CDITS (Clinical Documentation Indexing and Tracking System).•Categorized and attributed documentation appropriately using a sophisticated ORACLE-based indexing system (CDITS).•Domestic and International documentation consists of general correspondence, regulatory documents (FDA 1572, Financial Disclosure), protocol or protocol concept sheet, case report forms, adverse events, clinical study and statistical reports, shipping documents, etc.•Indexer must be knowledgeable of departmental SOPs and several COUSOPs (Clinical Operations Umbrella SOPs).•Responsible for ensuring documents are in compliance with SOPs.•Productivity and accuracy are closely monitored.•Query Crystal Reports database to find Facility/Site information, Subject information, etc. for some documentation and relate to appropriate documentation.•Verified information in the database fields or tabs that auto populate.•Obtained “Independent” status within 2 months; work reviewed on a “Spot-Check basis only”.
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  • Duke University Health System (Duhs) Or Duke University Medical Center (Dumc)
    Research Specialist
    Duke University Health System (Duhs) Or Duke University Medical Center (Dumc) Jul 2006 - Oct 2006
    Durham, North Carolina, Us
    Grant Funded PTGeneral Surgery/Anesthesiology•Clinical Research Assistant for Clinical Research Studies in Anesthesiology at VAMC [effective 07/10/2006 shared Research Specialist with Anesthesiology Dept (DUMC), VAMC, Durham, NC.] •Collected study patient vital signs, e.g. data from OR monitors per study protocol. •Collected, handled various types human specimens and medications per assigned protocol. •Recorded source data on CRFs; accessed PHI. •Set up for clinical research study according to protocol. •Shipped samples according to assigned protocol. •Trained to: a) Obtain informed consent and patient authorization from subjects for approved protocols. b) Obtain, organize data per assigned protocols. c) Input source data from interviews, etc. d) Maintain, facilitate complete and accurate data collection for relevant source documents and reports. e) Provide professional expertise, e.g. chart reviews per study protocol, as appropriate to credentials and training. f) Access PHI (Protected Health Information) to perform statistical analysis, or programming to produce reports and create data sets as needed. g) Prepare study initiation activities. h) Submit required study documents to IRB, R&D Committee, and funding sources (VA, non-VA). i) Develop recruitment methods for studies. j) Screen patients by eligibility criteria using PHI and/or by interviewing potential research subjects. k) Educate patient, relatives, and Medical Center staff regarding study activities as necessary per protocols.
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  • Duke University Health System (Duhs) Or Duke University Medical Center (Dumc)
    Research Specialist
    Duke University Health System (Duhs) Or Duke University Medical Center (Dumc) Jul 2002 - Oct 2006
    Durham, North Carolina, Us
    Grant Funded FTGeneral Surgery•Researched affects of surgical stress and sepsis on young vs. aging patients. Human and rodent models used. •Prepared lab solutions and cell culture media. •Cell separation techniques for blood using lymphoprep. •Cell Culture and manual cell counting using hemacytometer. •Immunological Staining for FACS analysis, cell culture, cell characterization assays, data analysis, and Luminex multiplex cytokine assays. • Performed literature searches including Medline and Ovid for articles relating to research focus.•Assisted with grant preparation, submissions as well as IRB and IACUC protocol submissions. •Acted as Safety Coordinator for the laboratory. •Autoclaved, disposed of biological waste. •Performed all ordering of literature, equipment, antibodies, reagents, and equipment service maintenance for the laboratory. • Accounted for laboratory expenses from Grants. Reconciled lab expenditures to detailed monthly Financial Statements and Activity Reports for each account. •Duke University online training and certification for Laboratory Safety, Radiation Safety, DUIACUC (Duke University Institutional Animal Care and Use Committee) Animal Handlers, and the Duke University Health System IRB (Institutional Review Board) Research Ethics.•DSRC (Duke Surgery Research Central) system used to complete federal grant submission tasks.
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  • Integrated Laboratory Systems
    Research Associate I
    Integrated Laboratory Systems Jan 2001 - Oct 2001
    Research Triangle Park, Nc, Us
    Information Sciences Division•Performed molecular assays; genetic and genetic toxicology assays. •Performed Comet Assay and SCGE (Single Cell Gel Electrophoresis) for invitro and invivo studies. Scored SCG slides (fluorescent staining) on the Komet Image Analysis system. •Performed data entry. Created and maintained excel spreadsheets of data analysis information. Ran statistical analysis (t-test and linear regression) on statistical information created from the study data of Excel worksheets with Statmost32. •Performed small amount tissue culture maintaining cell line. •Performed record keeping duties. Supported report, proposal, and cost estimate production.
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  • Integrated Laboratory Systems
    Histology Technician Ii
    Integrated Laboratory Systems Mar 2000 - Jan 2001
    Research Triangle Park, Nc, Us
    •Histology, toxicology, or carcinogenicity research in a GLP environment. •Necropsy, trimming, embedding, microtoming, routine and special staining, immunohistochemical staining and hybridization. •Changed processor and automatic stainer solutions. •Prepared for upcoming studies/ projects.•Reviewed slides.
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  • Duke University Health System (Dumc)
    Research Technician Ii
    Duke University Health System (Dumc) Feb 1999 - Mar 2000
    Durham, North Carolina, Us
    Experimental Surgery (Grant Funded FT)•Primarily prepared lymphocytes, plasma, and serum from HIV blood samples received from Trinidad by the Trinidad Study Protocol. •Maintained correspondence with Trinidad, West Indies site on expected shipments. •Prepared lymphocytes, plasma, and serum on HIV blood for other study protocols initiated from Duke ID (Infectious Disease) clinic. •Maintained correspondence with the ID nurses in charge of each study protocol. •Logged in blood samples for the Duke VEU (Vaccine Evaluation Unit) from AVEG (Aids Vaccine Evaluation Group) sites that came via FedEx and UPS. •Performed QC by Syncytia assay and mycoplasma testing for the Duke VEU. •Attended the Federal Express Corporation "Air Transportation of Dangerous Goods Seminar/Workshop" on 02-24 and 02-25-99. •Tracked shipments from FedEx and UPS not received overnight in timely manner.
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  • University Of North Carolina At Chapel Hill
    Research Technician/Technical Temporary
    University Of North Carolina At Chapel Hill Nov 1998 - Jan 1999
    Chapel Hill, Nc, Us
    Lineberger Comprehensive Cancer Center•Resolved Proteins through SDS-polyacrylamide gel electrophoresis. •Transferred proteins onto nitrocellulose paper and cut strips; blocked non-specific binding sites, used enzyme-linked reagents- Western Blotting; Autoradiography, Tissue Culture. •Solution preparation. Ordered chemicals and supplies; maintaining paperwork. •Set up ordering and filing system. Set up and tested lab equipment.
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  • University Of North Carolina At Chapel Hill
    Office Assistant Iii
    University Of North Carolina At Chapel Hill Sep 1998 - Nov 1998
    Chapel Hill, Nc, Us
    Human Resources•Entered applicant referrals into computer for the HR Recruiters.•Filed application in appropriate file locations.•Pulled applicant information for Recruiters to review for referral.•Copied and mailed out applicant referral packages.
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  • University Of North Carolina At Chapel Hill
    Office Assistant Iv
    University Of North Carolina At Chapel Hill Aug 1998 - Sep 1998
    Chapel Hill, Nc, Us
    Office of Financial Planning & Budgets and UNC University Cashiers• Temporary assignments within the University of North Carolina campus.• Filing, answering phone, checking mail, preparing documents with Microsoft Office 97.
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  • Gsk (Formerly Glaxo, Then Glaxowellcome)
    Histology/Necropsy Specialist
    Gsk (Formerly Glaxo, Then Glaxowellcome) Mar 1996 - Nov 1997
    Brentford, Middlesex, Gb
    Medicine Safety Evaluation (MSE)•Histotechnician. Fixed, trimmed, processed, embedded, microtomed, and stained tissues. •Performed Rodent and Dog necropsy, on-call weekend duty. •Produced high volume, quality slides for rodent, dog tissues for studies. •Archived/ inventoried GLP and Research studies. Assisted Pre-Archivist with QC and correction of study information before study materials go into the GlaxoWellcome GLP archives.•Sectioned cryostat frozen tissue and stain slides. •Handled Chemical Inventory and Disposal for laboratory. Maintained Chemical Equipment Database on laboratory computer. •Enhanced computing skills with Microsoft Word and Excel, Desktop Publishing, and HTML classes. Generally worked extra hours to meet deadlines. •Performed HT (ASCP) practical in September 1997.
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  • Monarch Technical Services (For Glaxowellcome, Inc. –Now Glaxo Smithkline)
    Histology Technical Temporary
    Monarch Technical Services (For Glaxowellcome, Inc. –Now Glaxo Smithkline) Mar 1994 - Mar 1996
    Medicine Safety Evaluation (MSE)•Histotechnician duties. •GLP training course; Phase I, II. •Created a Rodent Diagram Guideline for trimming, embedding of tissues. •Assisted with Rodent and Dog necropsy, mostly weighing tissues. •Entered study data into Microsoft Word and Excel spreadsheets and data tables. •QC data for studies create data tables for study data. •QC of screen dumps, correlations, and data tables utilizing screen dump information from PLACES validation by Pathologists.
  • Labcorp (Roche Biomedical Laboratories (Now Laboratory Corporation Of America/ Lab Corp)
    Technologist I
    Labcorp (Roche Biomedical Laboratories (Now Laboratory Corporation Of America/ Lab Corp) Dec 1991 - May 1994
    Burlington, North Carolina, Us
    Oncology Department•Processed, embedded, microtomed paraffin blocks; stained slides; prepared specimens and paperwork prior to testing. •Performed, analyzed routine tests on patient specimens per established procedures. •Record, release test results to be input into computer system. •Operated necessary manual/automated equipment. •Performed routine maintenance on laboratory equipment; maintained records.
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  • Duke University Medical Center (Dumc)
    Research Technician Ii
    Duke University Medical Center (Dumc) Apr 1992 - Oct 1993
    Durham, North Carolina, Us
    Center for Aging (Duke) and GRECC-Geriatric Research Education and Clinical Center (Grant Funded FT)•Preparation of bacteriophage lysates. Plasmid DNA, RNA, and protein purifications. •Random Primed DNA labeling- generated radioactive DNA probe. Polymerase chain reaction (PCR) of DNA. •Cloning with plasmid vectors. Synthesis of cDNA. Manual DNA sequencing. •Plated, screened cDNA libraries. Prepared LB broth and agar plates (autoclaving). Plaque purification of positive clones and transformation. •DNA restriction analysis. UV/VIS spectrometry. Agarose and acrylamide gel electrophoresis. Performed Northern Blot procedure. •Performed autoradiography, ultracentrifugation, and column chromatography. •Maintained radionucleotide use and purchase records; ordered supplies. •Performed literature searches through MEDLINE.
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  • Duke University Medical Center (Dumc)
    Research Technician I
    Duke University Medical Center (Dumc) Feb 1991 - Apr 1992
    Durham, North Carolina, Us
    Neurology (Grant Funded)•Performed and analyzed data of complex experimental protocols. •Performed small animal surgery and sacrifice administering anesthesia. •Processed, sectioned tissue using microtome, cryostat, and vibratome. •Performed various staining and immunocytochemistry procedures on tissue. •Extracted DNA from tissues. Ran agarose and acrylamide gels. Photographed gels; processed and developed negatives. •Prepared samples and ran protein assays. Performed UV/VIS spectroscopy. Ran, processed PAGE gels of protein samples. Performed Western Blots of proteins from acrylamide gels. •Assisted performance of microdialysis and HPLC experiments.
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  • Duke University Medical Center (Dumc)
    Medical Laboratory Technologist (N-Cert)
    Duke University Medical Center (Dumc) May 1990 - Feb 1991
    Durham, North Carolina, Us
    Duke North Clinical Labs (PT but sometimes worked FT filling in)•Ran stat, routine chemistry procedures on the Beckman Synchron CX3, Beckman Astra-8, the Dupont ACA III, and the Stratus Immunoassay System chemistry instruments. •Performed daily maintenance, calibrated using controls.•Programmed test panels and individual tests for serum, urine, CSF, and other body fluids.•Loaded sample kits with analytical test packs.
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  • Unc Health Care (Unc Hospitals)
    Medical Laboratory Assistant Iii
    Unc Health Care (Unc Hospitals) Sep 1988 - Jul 1991
    Chapel Hill, North Carolina, Us
    Clinical Microbiology•Accessioned procedures for Bacteriology, Immunology, Virology, and TB/Mycology in Lab Information System.•Prioritized, processed human specimens for culture inoculating appropriate agar/media.•Prepared slides from specimens.•Performed phlebotomy on patients to acquisition blood for cultures.
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  • Unc Health Care (Unc Hospitals)
    Data Entry Operator Ii (Formerly Medical Lab Assistant Ii)
    Unc Health Care (Unc Hospitals) Oct 1984 - Aug 1988
    Chapel Hill, North Carolina, Us
    Shared Laboratory Services•Retrieved patient specimens throughout hospital and transported to labs.•Managed specimen and patient reception windows.•Accessioned lab tests into the Laboratory Information System computer.
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  • Unc Health Care (Unc Hospitals)
    File Clerk Ii
    Unc Health Care (Unc Hospitals) Jan 1983 - Oct 1984
    Chapel Hill, North Carolina, Us
    Medical Records Circulation•Distributed patient records throughout the Hospital.•Compiled, sorted, and filed patient charts and materials.
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  • U.S. Department Of Veterans Affairs (Vamc)
    Medical Record Technician
    U.S. Department Of Veterans Affairs (Vamc) Aug 1988 - Jun 1990
    Washington, Dc, Us
    HSR&D- Health Services Research and Development (Initially FT, later PT)•Abstracted, coded medical and related service-connected and military data from claims folders for the National Spinal Cord Injury Project (SCI).•Identified pertinent records to National Spinal Cord Injury project.•Investigated, maintained flow claims folders to, from Veteran Affairs Regional offices; Entered data into SAS programs on Macintosh II and Compaq computers.
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  • University Of North Carolina At Chapel Hill
    Research Assistant (Unc Work-Study)
    University Of North Carolina At Chapel Hill Sep 1981 - Feb 1983
    Chapel Hill, Nc, Us
    Frank Porter Graham Research Center (UNC Work-Study program)•Catalogued, scored, and analyzed data for research projects on children grades K-2.•Extracted appropriate data from computer printouts and constructed new charts and tables.
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E. Annette H. Education Details

  • University Of North Carolina At Chapel Hill
    University Of North Carolina At Chapel Hill
    Zoology/Animal Biology

Frequently Asked Questions about E. Annette H.

What company does E. Annette H. work for?

E. Annette H. works for Icon Plc

What is E. Annette H.'s role at the current company?

E. Annette H.'s current role is Site Management Associate @ ICON plc, Clinical Trials Research;QM-IAOCR: Internationally Qualified TMF Manager (Reg: 9773967|23Aug2022);Q-IAOCR: Internationally Qualified TMF Associate (Reg: 9773967|16Aug2022).

What schools did E. Annette H. attend?

E. Annette H. attended University Of North Carolina At Chapel Hill.

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