E. Annette H. Email & Phone Number

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.

• 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)).

• 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.

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.
• 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.
• 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.
• 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 &.
• 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.

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.
• Indexer must be knowledgeable of departmental SOPs and several COUSOPs (Clinical Operations Umbrella SOPs).
• Responsible for ensuring documents are in compliance with SOPs.

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.

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.

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.
• Performed small amount tissue culture maintaining cell line.
• Performed record keeping duties. Supported report, proposal, and cost estimate production.

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.

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.

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.

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.

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.

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.

• 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.

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.

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.

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.

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.

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.

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.

Chapel Hill, North Carolina, US

• Medical Records Circulation
• Distributed patient records throughout the Hospital.
• Compiled, sorted, and filed patient charts and materials.

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.

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.