Experience

Biomea Fusion

• United States
• Biotechnology Research
• 1 - 100 Employee

• TMF Consultant

  • Jul 2023 - Present



Evidation

• United States
• Technology, Information and Media
• 100 - 200 Employee

• Recruiting Associate

  • Jun 2022 - Jul 2023

• eTMF and Training Manager

  • May 2021 - Jun 2022



Freenome

• United States
• Biotechnology Research
• 300 - 400 Employee

• Clinical Trial Assistant

  • Jun 2020 - May 2021



Clovis Oncology

• United States
• Biotechnology Research
• 1 - 100 Employee

• Clinical Document Specialist

  • Oct 2019 - Jun 2020



Dynavax Technologies

• United States
• Biotechnology Research
• 200 - 300 Employee

• Sr. Clinical Document Specialist

  • Jul 2018 - Sep 2019



Nektar Therapeutics

• Biotechnology
• 300 - 400 Employee

• Clincal Document Specialist II

  • Jan 2018 - Jun 2018

• Clinical Document Specialist

  • Jan 2015 - Dec 2017

  o Provide support to the clinical trial team with many of the tasks involved with the smooth running of clinical trials in compliance with Nektar processes. Collaborate with the clinical trial team in taking action to address issues as they arise.o Set up and maintain Trial Master Files and ensuring all relevant study documents are filed and archived based on the appropriate guidelines.o Review existing Paper or electronic Trial Master Files, collect outstanding documents and archive after study is completed.o Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CROs, vendors, etc.o Help manage clinical, regulatory and study-related essential documents such as study protocols, Informed Consent Forms, etc.o Interact with Investigator sites for activities such as to collect relevant documentation and study materials. Show less



Cerexa

• oakland, california

• Clinical Documentation Control Coordinator

  • Jun 2013 - Dec 2014

  Cerexa Inc. – 06/13 – Present – Clinical Document Coordinator - Set up clinical files for new studies on all levels as needed (compound, protocol and site). Maintain spreadsheets to track all incoming documents. Review/Process all documents for accuracy and completeness. Prepare documents for ClinOps review. Follow-up with ClinOps team member and resolve discrepancies. QC then prepare and scan all submitted documents. Ensure that all scanned documents are correct and available for posting/release. Ensure that all study documents are electronically tracked and filed in the TMF in a timely manner. Assist with document reconciliation as needed. Ensure appropriate access to documents including retrieval and photocopying/scanning of documents as requested. Participate in project team meetings. Provide input to established or new processes, working guidelines, and SOPs to ensure effective and efficient execution of clinical documentation operations. Show less



NorthStar Recovery Services

• United States
• Facilities Services
• 1 - 100 Employee

• Administrative Assistant

  • Jul 2011 - Oct 2012

  Northstar-Recovery - 7/5/2011- 10/15/2012 - Payroll Clerk/Receptionist - Made sure all hours on time sheets were correct with proper over time, made sure employees used correct viewpoint I.D numbers. Mailed out purchase orders and checks. Filed and scanned invoices and Expense Reports, called vendors for signed purchase orders and Certificate of liability Insurance .Kept records of invoices in numerical order, gathered time sheets for proper invoices that went out for check runs. Receptionist duties as needed. Show less



Luckys

• Oakland, ca

• Service Specialist

  • Oct 2008 - Jan 2012

  Lucky - 11/08- 01/12 - Service Specialist - Greet customers and engage in a professional manner helping them find their product, stock Items onto shelf, clean and maintain the appearance of the store, help customers out with groceries to their car . Lucky - 11/08- 01/12 - Service Specialist - Greet customers and engage in a professional manner helping them find their product, stock Items onto shelf, clean and maintain the appearance of the store, help customers out with groceries to their car .



Chevron Oil Refinery

• Richmond , ca

• Safety Attendant

  • Mar 2010 - Jun 2011

  Chevron Oil Refinery - 03/10- 06/2011 - Safety Attendant – Make sure contractors have proper P.P.E., firewatch , holewatch , clock contractors in and out from confined space entry, fill out J.H.A forms for every job,set up job area with proper equipment for contractors to be safe Chevron Oil Refinery - 03/10- 06/2011 - Safety Attendant – Make sure contractors have proper P.P.E., firewatch , holewatch , clock contractors in and out from confined space entry, fill out J.H.A forms for every job,set up job area with proper equipment for contractors to be safe