Consultant - Medical Writing/Clinical Development

• Feb 2023 - Present

Healthcare Investment Analyst

• Apr 2022 - Feb 2023

Senior Medical Writer

• Jun 2020 - Apr 2022

Medical Writer

• Jul 2019 - Jun 2020

Medical Writer

• Aug 2018 - Jul 2019

Clinical Research Coordinator - Medical, Surgical, and Radiation Oncology

• Feb 2017 - Aug 2018

Responsible for the execution of clinical trials at the study site level. My primary tasks included: - screening patients for trial eligibility - consenting patients for trial participation - amending patient treatment plans to ensure protocol adherence with regards to drug cycle schedule, dose hold/reduction constraints, safety labs, and nursing communications - coordinating study treatment with patient and facility schedules - adverse event evaluations of trial participants through direct interview - shipment of biological substances including tissue, serum, and plasma - ordering of Agendia mammaprint testing for trial participants - communicating with study monitors on ongoing site operations - generation of MRI volume reports through the Aegis and TRIAD systems - case report form (CRF) creation to ensure data accuracy - trial data entry into multiple EDC systems including Salesforce, Medidata, RedCap, Oncore - maintaining "audit ready" patient study binders - supporting regulatory submissions to our UCSD IRB in the form of continuing reviews and maintaining up to date trial delegation logs - point person during on-site and remote audits by the National Cancer Institute, sponsors, and co-operative groups (RTOG, NRG, NSABP, RADCOMP, etc) Show less

Clinical Trial Assistant

• May 2015 - Dec 2015

Primary responsibility of maintaining hard-copy and electronic Trial Master Files (TMF) Experience with data entry, patient screening, ethical and regulatory submissions on the international level, essential document handling, protocol and monitoring report revisions Training in Good Clinical Practice (GCP), Good Epidemiological Practice (GEP), Standard Operating Procedures (SOP's), and Trial Master File (TMF) maintenance Primary responsibility of maintaining hard-copy and electronic Trial Master Files (TMF) Experience with data entry, patient screening, ethical and regulatory submissions on the international level, essential document handling, protocol and monitoring report revisions Training in Good Clinical Practice (GCP), Good Epidemiological Practice (GEP), Standard Operating Procedures (SOP's), and Trial Master File (TMF) maintenance

Organic Growth & Innovation Intern

• May 2012 - Dec 2014

Intern with the Covanta Organic Growth and Innovation department primarily working on optimization of ferrous and non-ferrous metals recovery systems in the waste to energy generation process. Intern with the Covanta Organic Growth and Innovation department primarily working on optimization of ferrous and non-ferrous metals recovery systems in the waste to energy generation process.