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• Reviewed quality events and study deviations to assess risk, verify corrective actions, and implement preventive measures• Served as back-up point of contact in review and/or submission of CAP proficiency testing results• Assisted in conduct of internal facility audits and data collection/statistics for QA monitors, with an emphasis on areas of document control and inclusion patient testing• Assisted in preparation and conduct of sponsor audits and external inspections

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