Experience

Merigold LLC
• United States
• Accounting
• Lead Consultant

  • Mar 2020 - Present


Imaging Endpoints

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Associate Director, Medical and Scientific Affairs

  • Jul 2018 - Mar 2019

• Senior Scientist, Medical and Scientific Affairs

  • May 2017 - Jul 2018



PAREXEL Informatics, Medical Imaging

• Senior Medical Writer

  • Nov 2016 - Apr 2017

• Medical Writer II

  • Jan 2011 - Nov 2016

  • Analyze and interpret clinical trial protocols • Develop independent imaging review charters that ensure efficient and effective support of protocol imaging dependent endpoints• Develop Reviewer Manuals for training of independent reviewers (radiologists or other clinical experts) on trial specific assessment criteria and analysis application use.• Facilitate discussions between clients and Perceptive’s medical, operational and application development teams • Maintain familiarity with regulatory expectations in regards to the independent review of imaging in clinical trials including but not limited to GCP and 21 CFR Part 11• Maintain a good working knowledge of internal analysis application functionality• Author indication specific modules, templates and therapeutic area guidance• Train internal team members from other internal departments on medical writing workflows and practices• Mentor and provide support for new medical writing team members• Maintain central content/knowledge repository Show less

• Imaging Research Associate

  • Jul 2010 - Dec 2010

  • Assisted project managers in sending out site and team correspondence, maintained study tracking spreadsheets and reports, scheduled weekly meetings, taking detailed meeting minutes and appropriately and effectively updated study teams with new and pertinent study related information• Authored and proofread documents for study startup and site qualification including site surveys and imaging acquisition guidelines• Mentored and assisted in the training of new team members• Acted as liaison with study coordinators, radiologists, technologists, and clinical research associates to resolve issues and questions that arise throughout the clinical trial• Addressed questions to ensure that investigational site personnel are comfortable with the protocol and requirements of the study • Ensured study related documents and practices were in adherence with Good Clinical Practices (GCP) regulations, applicable regulatory requirements (i.e. 21CFR Part 11), applicable departmental and companywide SOPs, and project specific protocol requirements• Executed study specific image processing steps (including downloading imaging data from foreign media, delineating region of interest measurements and ensuring proper imaging parameters are met) across multiple modalities (including but not limited to CT, MRI, x-ray and bone scan) using proprietary software, as well as other third party packages as appropriate Show less

• Imaging Assistant

  • Oct 2009 - Jul 2010

  • Responsible for maintaining and updating the project spreadsheets, scheduling meetings, taking detailed meetings minutes and effectively communicating changes and updates to applicable study team members• Data entry, quality control checks, and study document and media filing• Developed and coordinated study related activities in compliance with FDA Regulatory Requirements• Converted medical image data to digital form and maintain a database of medical images and associated results• Responsible for providing initial clinical trial site contact and support Show less