Stacey Herrera

Experience

• 

  Virginia Department of Health

  Jun 2014 - Apr 2015

  Alexandria MRC Volunteer

  Support public health in an emergency or disaster.

• 

  Smithsonian Institution, Museum of Natural History

  Feb 2015 - May 2015

  Intern

  Checking and updating scientific names of insects against current classification, labeling storage units with current names and capture of the basic taxonomic information into a template: Family, genus and species names; Author and Year of publication.

• 

  National Museum Of Natural History

  Apr 2016 - Aug 2016

  Intern

  Worked under the curator of Diptera with the objective of sequencing flies.Used variety of laboratory techniques: DNA Extraction, PCR, Gel electrophoresis and Sanger sequencingUtilized Geneious software for editing of sequence fragments.

• 

  Virginia Hospital Center

  Jul 2016 - Dec 2016

  Volunteer

  Assisting receptionists through a variety of tasks such as phoning patients with appointment reminders, organizing files, and ensuring forms were available and ready to use. Majority of time was spend filing patient files and ensuring doctors had corresponding patient files. Other duties included cleaning beds and leaving rooms ready for use; for example, stocking linens and robes. Occasionally I was responsible for calling patients in. Under supervision I could check weight and blood pressure. When needed, I escorted patients to outpatient lab or labor and delivery unit. Also when needed, I translated for doctors during patient interview. Show less

• 

  The ACI Group

  Jan 2017 - Feb 2017

  Quality Control Technician

  Ensured all finished products were free from errors. Inspected products for adherence to quality standards and identified defects. Inspection was completed visually and via listening to audio recordings.

• 

  Hoya Staffing

  May 2017 - Dec 2017

  Data Specialist/Financial Assistant

  Temporary full time position within the Clinical Trials Office at Georgetown University Medical Center.Job Overview: Transferring legacy and current data (over 400 non-oncology and oncology clinical trials) into a new system, OnCore CTMS. Responsible for data migration and process flow. Managing and verifying data to ensure data quality. Tasks include: Building calendars for schedule of events of clinical trials. Budget analysis; for example, ensuring schedule of events match budget and that all billable items are correct. Training and support of new system when needed.Achievements: Successfully launching new system with active studies. Show less

• 

  Georgetown University Medical Center

  Dec 2017 - Dec 2021

  Senior Regulatory Specialist

  Participate in all regulatory related Clinical Research Management Office (CRMO) activities, preparing, maintaining, and coordinating regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for sponsor-initiated clinical research studies. Reporting to the Regulatory Manager in streamlining processes and assisting in the implementation of standardized functions, duties that include but are not limited to:For All Trials- Coordinate and facilitate Clinical Research Committee (CRC), Institutional Biosafety Committee (IBC), and Institute Review Board (IRB) submissions, including initial submissions, amendments, Informed Consent Form (ICF) changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance.- Enter study information and ensuring accuracy of information in Oncore.- Communicate with investigators and research staff (study team) throughout the various stages of the study life cycles.- Inform research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments.- Create and make revisions to informed consent and HIPAA forms.Regulatory Management - Industry Sponsored Trials- Maintain essential regulatory documents including Financial Disclosure Form (FDF), Statement of Investigator (Form FDA 1572), Delegation of Authority (DOA) logs, and other study-related documentation.- Prepare for and participate in sponsor monitoring visits and audits.CRMO Administration- Assist in the development and implementation of policies and Standard Operating Procedures (SOP).- Attend applicable Lombardi Comprehensive Cancer Center (LCCC) meetings – for example, disease group meetings, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits.Outside Tasks:Building calendars in OnCore CTMS for non-oncology federally funded clinical trials. Show less

• 

  Guardant Health

  Dec 2021 - now

  Clinical Project Manager

  Focus on research use only (RUO) oncology studies:- Leading, monitoring, and maintaining operation timelines by ensuring samples received go through intake and that lab has the necessary information to process the samples.- Developing data transfer agreements with pharma partners along with completing data transfers- Identifying barriers to timely and successful project operation execution and resolving discrepancies with pharma partners.- Developing methods to track, monitor, and report operations metrics.- Assisting on invoicing within department projects Show less