Clinical Research Quality Control
Resume:
Macie M. Lieberman
ad5oeh@r.postjobfree.com
Professional Summary
Highly motivated individual with 7 years of clinical and research background. Experienced in managing teams, time-sensitive projects, developing and sustaining relationships, and streamlining workflow. Possesses excellent interpersonal communication skills, presentation skills and high ability to problem solve, prioritize, make efficient decisions, and work effectively in a highly dynamic environment.
Skills
•Protein purification, ELISA, electrophoresis, PCR, HPLC, GCMS, DNA isolation, oligonucleotide synthesis, mass spectrometry, DNA sequencing, Centrifugation, Western Blot
•Knowledge of clinical research terminology, regulations, and procedures.
•Strong computer skills (spreadsheets, databases, and interactive web-based software).
•Proactively works to maximize results of team and organization.
•Fosters collaboration through affable communication and resourceful problem solving.
Professional Experience
UT Southwestern (Dallas, TX) April 2022 – March 2023 Research Study Coordinator (Clinical)
•Independently wrote technical investigations that included a root cause and corrective action, i.e. nonconformance reports and corrective action reports.
•Under the direction of Investigators, coordinated research projects, regulatory aspects of trials, and ensured quality control of research data in compliance with industry standards.
•Conducted statistical analysis on data collection
•Screened, recruited, consented, enrolled, and followed subjects according to protocol guidelines, by patient interaction and abstracting information from medical records.
•Assisted in developing, updating and implementing research protocols.
•Maintained and coordinated data collection, conducted study procedures, and monitored patient safety.
•Proficient in the clinical trial management system, electronic medical record, and other data entry systems.
•Tracked and reported adverse events, serious adverse events, protocol waivers, deviations, and violations.
•Prepared studies for audit - filed interim reports, completed continuing reviews, addressed monitoring reports, prepped Radiation Therapy Quality Assurance Reviews.
•Coordinated study procedures such as blood draws, biopsy, imaging, treatment and surgery dates.
UT Southwestern (Dallas, TX) January 2021 – April 2022
Sr. Administrative Assistant II
•Provided research administrative support to physicians and scientists including managing laboratory inventory, editing and submitting grants, managing relationships with vendors, processing equipment orders and EAJs, reviewing contracts, calendar management, preparing travel and processing travel expenses, submitting orders, processing invoices for payment, reconciling accounts, maintaining CVs.
•Logistical lead for HERO grant and conference.
UT Southwestern (Dallas, TX) January 2020 – December 2020 Research Associate
•Performed Cardiology and Down Syndrome research on mice
•Examined effect on RCAN1 on mitochondrial morphology
•Trained lab personnel on mouse handling and injections
•Extensive experience with molecular biology (PCR), electrophoresis (agarose and polyacrylamide), and genotyping
•Exposure to molecular techniques, RNA and DNA isolation, cryopreservation of cells, protein expression and mutagenesis, some cell culture and protein analysis
NemaMetrix (Murray, UT) April 2019 – July 2019 Genetics Technician II
Used CRISPR-Cas 9 to alter the DNA of C. elegans and analyzed phenotypical mutations, designed primers, ran PCR reactions, extensive genotyping.
Biofire Defense (Salt Lake City, UT) May 2018 – February 2019 Research Associate and Data Analyst
In a BSL2+ lab, performed in silico and benchtop analyses on blood samples containing irradiated Anthrax, Ebola, Y. Pestis, Marburg, F. tularensis, and presented findings at department meetings. Performed data analyses for Quality Control and Stability studies. Coded figures in R Studio and wrote reports on findings.
Analytical Resource Laboratory (Lehi, UT) March 2017 – March 2018 Lead Microbiologist
•Wrote and reviewed validation protocols and technical reports
•Maintained QC Analytical Laboratory in compliance with regulatory standards and site procedures.
•Supervised 5 technicians at a BSL-2 laboratory while also managing the labs budget, writing SOP (Standard Operations Procedures), ordering supplies, tracking inventory, and writing certificates of analysis reports
•Became proficient at root cause investigation and taking corrective/preventive action process from the finding
•Served as spokesperson and salesperson for the lab
•Ensured products met specification and the lab operated under ISO standards
•Used problem solving and critical thinking to streamline daily lab operation
•Participated in lab audits
•Designed validation methods
Brigham Young University Idaho (Rexburg, ID) 2015 – 2017 Research Assistant
Extracted polyphenol anti-cancer properties from specific fruit. Studied brominated Nopol’s steric effects. Researched and developed 3D-printed proteins to aid the professors in classroom instruction. Oversaw the execution of proper lab Equipment and chemical set-up of all chemistry labs, managed and procured all inventory for the chemistry stockroom. Trained students on proper laboratory techniques.
University of Idaho (Moscow, ID) June – August 2016
Research Intern
Categorized efficiency of various RNA - Targeting Oligonucleotides on bovine sperm cells, presented findings at the INBRE Annual Research Conference. Managed cell culture and growth. Attached probes using various buffer solutions and analyzed probes affinity for strains.
Education
Brigham Young University - Idaho (Rexburg, ID) Bachelor of Science in Biochemistry
National Healthcare Certification Organization
Certified Phlebotomy Technician – CPT,
Certificate# 106016, Issued 10/01/2016
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