Miranda Helus Email & Phone Number

• Performs part-time, contract copyediting services for the Product Implementation Resources team
• Reviews and proofreads product instructional materials for style consistency, grammatical accuracy, and language clarity for audiences of Pre-K–12 students and educators

Lake Forest, California, United States

• Reviewed final study reports (validation and clinical) to ensure data quality & regulatory compliance before submission to clients and closure of studies
• Served as SOP coordinator by overseeing requests for creating, revising, implementing (including training applicable personnel), & archiving controlled documents
• Served as a site subadmin and the primary document control admin on company-wide eQMS MasterControl
• Reviewed electronic data transfers for data accuracy/integrity & compliance with study protocols and data transfer agreements outlined by clients
• Reviewed validation of critical lab equipment and software to ensure all qualification steps were performed in accordance with SOPs, GxP, and CAP/CLIA guidelines
• Coordinated the process of alternative performance assessment in accordance with CAP/CLIA guidelines for all non-PT assays used in prospective studies

Lake Forest, California, United States

• Reviewed spreadsheets and data transfers for data accuracy/integrity & compliance with study protocols
• Served as SOP coordinator by overseeing requests for creating, revising, & archiving controlled documents
• Assisted in configuration of the new eQMS MasterControl, including the rollout of the Documents and Training modules from fall 2021 to spring 2022
• Reviewed qualification and validation of critical lab equipment and software
• Coordinated the validation process for Excel formulas to be used in the transcription and QC of data
• Reviewed and signed off on disposal requests by the logistics or lab teams

Lake Forest, California

• Performed takedown process by making and QC’ing data analysis paperwork for current studies
• Supervised other Project Assistants and checked their takedown for completion and accuracy
• Tracked daily status/progress of takedown by organizing studies, scheduling deadlines, and setting timelines based on changing priorities
• Filed old reference slides and paperwork
• Updated clinical trial trackers and schedules
• Transcribed data into Excel spreadsheets and tables

• Research focused on G-protein coupled receptor interactions and biased agonism
• Assisted in preparation of biological samples using centrifugation methods
• Generated computer models using data simulation and performed calculations using Prism software
• Documented study and the results in an honors thesis for the UCI Campuswide Honors Program

• Assisted students with questions regarding class material during office hours
• Conducted midterm and final exam review sessions each quarter

• Wrote articles for Morning Sign Out, an online healthcare newsletter
• Independently and collaboratively wrote articles on current events in pharmacy or wellness
• Researched topics using digital or physical resources such as public health databases and news media
• Implemented feedback from editors

Los Alamitos, California

• Assisted in refill orders
• Provided customer service and handled customer transactions
• Answered phones and responded to faxes
• Labeled over-the-counter medications

Orange County, California Area

• Shadowed UCI Medical Center pharmacists in various departments as part of UCI's PharmSci Professional Summer Internship
• Assisted with stock management and organized emergency carts
• Filled medication orders and filed paperwork

Master Of Science - Ms, Management Of Drug Development

Bachelor Of Science - Bs, Pharmaceutical Sciences

Activities and Societies: Pre-Pharmacy Society, Morning Sign Out, Campuswide Honors Program