Janine (Wrolstad) Wiese

Clinical Affairs Manager at ChromaCode, Inc.
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Contact Information
us****@****om
(386) 825-5501
Languages
  • English -

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Jade Clarke

Janine is a positive, detailed oriented person with a team player attitude. She is an expert Treasurer for the Health Care Administration Student Forum. She has balanced the budget for this semester well, and her spreadsheets are professional.

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Credentials

  • National Certified Phlebotomy Technician I
    California Department of Health Care Services
    Apr, 2015
    - Sep, 2024

Experience

  • ChromaCode, Inc.
    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Clinical Affairs Manager
      • Nov 2021 - Present

      • Manage all CRO activities including study timelines, clinical monitoring, data entry, & project plans • Partner with Regulatory, CRO & cross functional teams in the design and execution of clinical trials – adhere to GCP • Lead the clinical sample mgmt. team • Oversee/track all aspects of the study (e.g. status, samples, enrollment, etc.) • Partner with R&D for development & internal verification studies • Support study execution for alpha/beta testing sites, external verification sites • Partner with the Scientific Affairs Committee to support studies • Partner with Legal & Regulatory to ensure NDAs, contracting, & agreements for external studies • Develop, write, & implement processes/SOPs • Present/communicate results

  • PrecisionMed
    • Australia
    • 1 - 100 Employee
    • Clinical Site Development Manager
      • Mar 2018 - Nov 2021

      • Manage and increase productivity of existing sample collection clinical sites • Locate, contract with and initiate new sample collection clinical sites • Draft and submit protocols as well as marketing materials to the Western Institutional Review Board • Consent patients and collect data per protocol • Process samples in the laboratory • Maintain inventory • Manage and increase productivity of existing sample collection clinical sites • Locate, contract with and initiate new sample collection clinical sites • Draft and submit protocols as well as marketing materials to the Western Institutional Review Board • Consent patients and collect data per protocol • Process samples in the laboratory • Maintain inventory

  • UC San Diego Health
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Clinical Research Coordinator Experimental Therapeutics Oncology
      • Oct 2016 - Mar 2018

      • Coordinate and manage multiple clinical trials Phases I & II at UCSD Moores Cancer Center • Screen for patient eligibility • Data collection and analysis • Ensure protocol compliance • Monitor patient treatment and toxicities • Laboratory and specimen processing/packaging/shipping • Direct communication with assigned physicians and disease groups • Attend weekly Molecular Tumor Board meetings • Provide direct assistance to Project Managers • Coordinate and manage multiple clinical trials Phases I & II at UCSD Moores Cancer Center • Screen for patient eligibility • Data collection and analysis • Ensure protocol compliance • Monitor patient treatment and toxicities • Laboratory and specimen processing/packaging/shipping • Direct communication with assigned physicians and disease groups • Attend weekly Molecular Tumor Board meetings • Provide direct assistance to Project Managers

  • Ionis Pharmaceuticals, Inc.
    • United States
    • Biotechnology Research
    • 500 - 600 Employee
    • Drug Safety Associate Pharmacovigilance
      • Jul 2016 - Oct 2016

      • Maintain, organize, track and file safety documents • Format Safety Management Plans, SOC Power-Point presentations, etc. • Assist with oversight of SAE case status and query status • File SAE cases, source documents, triage, etc. into internal electronic storage portal • Maintain protocols, Investigational Brochures, trial updates and SMPs in Quick-Base portal for CROs (original and when amended) • Maintain, organize, track and file safety documents • Format Safety Management Plans, SOC Power-Point presentations, etc. • Assist with oversight of SAE case status and query status • File SAE cases, source documents, triage, etc. into internal electronic storage portal • Maintain protocols, Investigational Brochures, trial updates and SMPs in Quick-Base portal for CROs (original and when amended)

  • Toolbox Medical Innovations
    • United States
    • Medical Device
    • 1 - 100 Employee
    • Clinical Research Associate In Vitro Diagnostics (IVD)
      • Oct 2015 - May 2016

      • Remote monitoring activities • On-site Initiation Visits • Interim Monitoring Visits • Study Close-Out Visits • Database management • Query issuing/resolution • Specimen shipment tracking • Inventory and replenishment of protocol specific supplies • Blood draws and finger sticks during site initiation • Blood draws and finger sticks weekly for Engineering Product Development • Remote monitoring activities • On-site Initiation Visits • Interim Monitoring Visits • Study Close-Out Visits • Database management • Query issuing/resolution • Specimen shipment tracking • Inventory and replenishment of protocol specific supplies • Blood draws and finger sticks during site initiation • Blood draws and finger sticks weekly for Engineering Product Development

  • UCI Health
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Clinical Research Coordinator Movement Disorder Clinic Neurology
      • Jan 2015 - Oct 2015

      • Clinic visits with study participants • Vitals, blood pressure, ECGs, temperature, etc. • IRB submissions • Subject recruitment, pre-screening, & enrollment • Subject chart & lab preparation/processing/shipment • Protocol specific follow-up • Schedule subsequent subject visits per protocol timeline • Clinic visits with study participants • Vitals, blood pressure, ECGs, temperature, etc. • IRB submissions • Subject recruitment, pre-screening, & enrollment • Subject chart & lab preparation/processing/shipment • Protocol specific follow-up • Schedule subsequent subject visits per protocol timeline

  • Trader Joe's
    • Museums, Historical Sites, and Zoos
    • 1 - 100 Employee
    • Customer Service Representative
      • Aug 2013 - Dec 2014

      • Efficient customer service • Team leader • Cashier & credit transactions • Product knowledge • Efficient customer service • Team leader • Cashier & credit transactions • Product knowledge

  • Old Navy
    • United States
    • Retail
    • 700 & Above Employee
    • Customer Service Representative
      • Aug 2006 - Aug 2013

      • Efficient customer service • Cashier duties • Product knowledge • Team leader • Efficient customer service • Cashier duties • Product knowledge • Team leader

  • California State University, Long Beach
    • United States
    • Higher Education
    • 700 & Above Employee
    • Treasurer for CSULB Health Care Administration Student Forum
      • Aug 2012 - May 2013

      • Budgets • Financial transactions • Accounting for organization member payments • Arranging key note speakers for organization meetings • Budgets • Financial transactions • Accounting for organization member payments • Arranging key note speakers for organization meetings

  • Long Beach Memorial Medical Center
    • United States
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Clinical Research Intern - Perinatal
      • Dec 2012 - Apr 2013

      • Subject screening • Physician contact to obtain patient medical records • Chart preparation • Confirming / re-scheduling subject visits • Subject screening • Physician contact to obtain patient medical records • Chart preparation • Confirming / re-scheduling subject visits

Education

  • California State University-Long Beach
    Bachelor of Science (BS), Health/Health Care Administration/Management
    2007 - 2013
  • Allied Professional Institute - Medical Education
    Certified Phlebotomy Technician, Phlebotomy Technician/Phlebotomist
    2015 - 2020
  • Rancho Buena Vista High School
    High School Diploma, General Studies
    2003 - 2007

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