Jenna Hart

Experience

• 

  St.Edward's University

  May 2010 - May 2012

  • Undergraduate Laboratory Assistant

    Jan 2012 - May 2012

  • Teaching Assistant

    Aug 2010 - Dec 2011

  • Undergraduate Researcher

    May 2010 - Aug 2010
• 

  The University of Texas at Austin

  May 2011 - Aug 2011

  Undergraduate Research Assistant
• 

  The University of Texas at Austin

  May 2012 - Oct 2015

  Assisted in ongoing research projects as Lab Manager.In charge of maintaining the lab’s mouse facility, plasmid/bacterial library, and cell culture library.In charge of lab administrative functions such as purchasing equipment and creating budgets. Assisted in ongoing research projects as Lab Tech.In charge of maintaining the lab’s zebrafish facility and computer database.Performed research independently and presented findings at weekly lab meetings.Able to read peer-reviewed literature.

  • Research Engineering/Scientist Assistant I

    Aug 2014 - Oct 2015

  • Research Engineering/Scientist Assistant II

    May 2012 - Jul 2014
• 

  PPD

  Oct 2015 - Mar 2017

  Responsible for accurate data entry for Phase I clinical trials.Worked with Project Manager and CRAs to ensure timelines met in regards to data entry. Coordinated Phase I clinical studies including setting up studies that meet up to protocol standards.Responsible for the completion of all paperwork required to accurately capture all data specified by a study protocol.

  • Clinical Data Associate

    Jul 2016 - Mar 2017

  • Clinical Research Coordinator

    Oct 2015 - Jul 2016
• 

  IntegReview IRB

  Apr 2017 - Oct 2020

  Responsible for the processing and follow-up of activities associated with full board review of new studies Facilitates weekly and unscheduled IRB meetingsReview of items that qualify expedited review following initial approval Responsible for the processing and follow-up of activities associated with expedited review of new studies that meet the criteria for expedited review as identified in the Federal RegisterResponsible for the processing and follow-up of activities associated with the review of exempt researchAssists the Coordinator/Co-chair with facilitating IRB meetings when Coordinator/Co-chair is not available Responsible for processing and distributing study-related material that meet the full board or expedited review with a 48 hour turnaround time.Ensure complicate with FDA regulations, Standard Operating Procedures, and GCP/ICH guidelines.Provide excellent customer service to clients.

  • IRB Coordinator/Co-Chair

    Sept 2019 - Oct 2020

  • Assistant Coordinator

    Oct 2018 - Sept 2019

  • IRB Administrative Associate II

    Apr 2017 - Oct 2018
• 

  Syneos Health

  Oct 2020 - now

  Set-up, maintain and/or close out project files and study information (e.g., regulatorydocuments, Trail Master File (TMF), enrollment, Adverse Events (AEs)/ Serious Adverse Events(SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety ofdatabases and systemsAttends, participates, prepares and distributes meeting minutes and action items for bothinternal and external meetings (sponsor, trusted process, functional, investigator meetings)Maintains timely and effective communication among team members and site staff. KeepsProject Leadership and Clinical Research Associates (CRAs) fully appraised of sites and studystatusProvide administrative support to Project Leads and functional leadsEnsure all study documents are archived based on the appropriate guidelines and policyProvide support for quality assurance activities, including preparation for audits and internalreview, prepare documentation and follow through to resolution on actionable issues Show less Set-up, maintain and/or close out project files and study information (e.g., regulatorydocuments, Trail Master File (TMF), enrollment, Adverse Events (AEs)/ Serious Adverse Events(SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety ofdatabases and systemsAttends, participates, prepares and distributes meeting minutes and action items for bothinternal and external meetings (sponsor, trusted process, functional, investigator meetings)Maintains timely and effective communication among team members and site staff. KeepsProject Leadership and Clinical Research Associates (CRAs) fully appraised of sites and studystatusProvide administrative support to Project Leads and functional leadsEnsure all study documents are archived based on the appropriate guidelines and policyProvide support for quality assurance activities, including preparation for audits and internalreview, prepare documentation and follow through to resolution on actionable issues Show less

  • Sr Project Specialist

    Jun 2022 - now

  • Project Specialist

    Oct 2020 - Jun 2022