Marian Hemmelgarn

Associate Partner and Gene Therapy Biosafety Officer at Clinical Biosafety Services
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Contact Information
us****@****om
(386) 825-5501
Location
Morrisville, North Carolina, United States, US
Languages
  • English Native or bilingual proficiency
  • Spanish Native or bilingual proficiency

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Bio

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Credentials

  • Certified Clinical Research Professional (CCRP)
    -

Experience

  • Clinical Biosafety Services
    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Associate Partner and Gene Therapy Biosafety Officer
      • Nov 2020 - Present

      Our mission and expertise at Clinical Biosafety Services is to provide accelerated, compliant review of gene transfer/gene therapy clinical trials to a convened review of a site-specific Institutional Biosafety Committee (IBC). We do this by understanding the challenges in the two client relationship of serving an institution and a sponsor. Our focus is to accelerate the trial, and remove regulatory burden and uncertainty by having our highly trained experts provide friendly, knowledgeable support during the review process. We understand these therapeutics will change medicine, and our service is to bring the trial to enrollment fruition, quickly and compliantly. Show less

  • Jackson Health System
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Clinical Trials Coordinator
      • Oct 2019 - Nov 2020

      Jackson Health System’s Office of Research was established to carry out the organization’s goal of providing a high standard of quality care for its patients, while facilitating clinical research studies which may improve overall healthcare for patients at Jackson facilities. As Clinical Trials Coordinator, my main responsibilities entailed guiding new Principal Investigators (PI’s) during Project Startup and Research Review Committee process with a focus on reconciliation of proposed procedures and research calendars with the study protocol. Major tasks also included revising Research Office Policy and SOP’s to ensure fidelity with current Federal Regulations and ICH guidelines. Show less

  • University of California, Los Angeles
    • Information Services
    • 1 - 100 Employee
    • Program Manager
      • 2016 - 2018

      At UCLA, I had the opportunity to implement a pilot Breast Cancer Navigation Program at a Medical Center in South Los Angeles. My role involved identifying systematic barriers to treatment access, working collaboratively across departments to tackle those issues, aligning project progress and budget, training navigators, and customizing services to suit the needs of patients in breast cancer treatment. At UCLA, I had the opportunity to implement a pilot Breast Cancer Navigation Program at a Medical Center in South Los Angeles. My role involved identifying systematic barriers to treatment access, working collaboratively across departments to tackle those issues, aligning project progress and budget, training navigators, and customizing services to suit the needs of patients in breast cancer treatment.

  • BRENTWOOD BIOMEDICAL RESEARCH INSTITUTE, INC.
    • Biotechnology Research
    • 1 - 100 Employee
    • Research Coordinator
      • 2014 - 2017

      As a Research Coordinator, I was primarily engaged in reviewing operative reports of rectal cancer patients, looking at specific variables of surgeon technique, and analyzing adherence to technical quality measures for rectal cancer surgery. I also produced data tables and reports for project-related presentations and publications. As a Research Coordinator, I was primarily engaged in reviewing operative reports of rectal cancer patients, looking at specific variables of surgeon technique, and analyzing adherence to technical quality measures for rectal cancer surgery. I also produced data tables and reports for project-related presentations and publications.

    • Assistant Public Administration Analyst
      • 2010 - 2015

      At this point in my career, my role entailed assessing the efficacy of adapted breast cancer survivorship materials and producing resources for the research project. I also directed crucial documentation including maintaining IRB submissions and renewals, and was responsible for gathering data for manuscripts, grant proposals, and project update reports At this point in my career, my role entailed assessing the efficacy of adapted breast cancer survivorship materials and producing resources for the research project. I also directed crucial documentation including maintaining IRB submissions and renewals, and was responsible for gathering data for manuscripts, grant proposals, and project update reports

  • Dana-Farber Cancer Institute
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Project Manager
      • 2008 - 2010

      At Dana-Farber Cancer Institute, I managed research projects focused on studying genetics and detecting gastrointestinal malignancies in its nascent stages. I implemented project management concepts, drove data collection and analysis efforts, and presented study updates at semi-annual consortium meetings. At Dana-Farber Cancer Institute, I managed research projects focused on studying genetics and detecting gastrointestinal malignancies in its nascent stages. I implemented project management concepts, drove data collection and analysis efforts, and presented study updates at semi-annual consortium meetings.

  • Harvard University
    • United States
    • Higher Education
    • 1 - 100 Employee
    • Project Coordinator
      • 2006 - 2008

      My deliverables as a Project Coordinator at Harvard University included preparing annual progress reports for US-based and international research projects while serving as a Study Contact for subcontractors across all locations. I was an integral part of a research project aimed at identifying the effects of pesticides on children exposed to floriculture environment in the prenatal stage (In Utero). Moreover, I performed as an Editorial Assistant for the online journal “Environmental Health”, and assisted with arranging international conferences and meetings. Show less

  • Boston University, Research Administration
    • Biosafety Committee Coordinator
      • 2003 - 2006

      As Biosafety Committee Coordinator, I was tasked to complete administrative duties including database management, scheduling, and coordinating meetings. I ensured hassle-free application intake, ensured strict adherence to federal and state regulations as well as internal policies, and drafted annual reports for NIH & BPHC. As Biosafety Committee Coordinator, I was tasked to complete administrative duties including database management, scheduling, and coordinating meetings. I ensured hassle-free application intake, ensured strict adherence to federal and state regulations as well as internal policies, and drafted annual reports for NIH & BPHC.

  • Boston Medical Center (BMC), General Internal Medicine Division
    • Research Associate
      • 2000 - 2003

      I started my career here by screening and enrolling inpatients, and administering questionnaires focused on alcohol consumption for Project ASAP, a substance abuse research study. I leveraged knowledge of the Spanish language to produce documents in Spanish. I started my career here by screening and enrolling inpatients, and administering questionnaires focused on alcohol consumption for Project ASAP, a substance abuse research study. I leveraged knowledge of the Spanish language to produce documents in Spanish.

Education

  • Boston University
    Master of Public Health - MPH -Cum Laude
    2003 - 2006

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