HANNAH SHERMAN
Marion,TX
Summary
Clinical research professional with 10+ years of experience in Pre-clinical through Phase 4 trials. Key experiences include biomarker, oncology, pain, rare disease(CF, AATD) and medical device trials with various study designs.
Overview
12
12
years of professional experience
Work History
Biosample Operations Specialist
ICON Strategic Solutions
Marion, TX
05.2023 - 10.2025
- Collaborates with data management team monthly to complete PK reconciliation reports to locate missing PK samples
- Ensures samples remaining in long term storage after study closure are discarded properly or shipped to third party lab in a timely manner
- Works closely with study teams to manage monitoring of appropriate patient consent for all biosample collection and testing
- Interfaces with laboratory personnel, sample processing and other vendors to ensure proper shipment and receipt of samples, responding to queries to ensure study objectives for clinical biomarkers are met
- Reviews clinical study protocols, informed consent forms, laboratory documents, case report forms and service provider laboratory scope of work documents for sample handling details
- Collaborates with study teams and biomarker scientists to develop biological sample management plans in concurrence with sites, and central and specialized laboratories for all biomarker samples
- Accountable for planning, coordinating and overseeing all operational activities required to manage the lifecycle of biomarkers samples ensuring sample integrity and GCP compliance throughout the process
- Assists study teams with periodic PK data reviews to ensure all PK samples are delivered to third party labs
Senior Research Associate
Scorpius Biomanufacturing
San Antonio, TX
01.2023 - 05.2023
- Support quality assurance group by assisting in document control, calibration, and preventative maintenance support, change control, deviation reporting, CAPA risk analysis
- Responsible for working with PD team staff to modify existing "R&D" manufacturing processes and develop them for clinical scale, cGMP-compliant manufacturing
- Collaborate on process transfer from Scorpius process development group and/or external client teams
- Support cGMP manufacturing activities including documentation and manufacture of clinical grade biologics
- Order/Track cleanroom supplies through Tipalti ordering system
- Maintain cleanroom supply as well as track expired materials, discard, and restock as needed
- Collaborate with operations staff in the execution process of the ongoing environmental control program including facility cleaning and environmental monitoring procedures
Clinical Sample Manager
Scorpius Biomanufacturing
San Antonio, TX
02.2022 - 12.2022
- Respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, colleagues, and outside constituents
- Managing communications with clients and vendors on receipt, returns, discrepancies and close outs
- Managing local and global shipment of blood, cell, and serum samples, electronically and storage in freezers
- Aseptic handling of human blood, isolation of PBMCs, counting, freezing, and completing all the necessary paperwork
- Sample receiving, login, inventory control and custody, and shipping
- Maintaining the general up-keeping of the lab and keep the equipment in working order
- Chemical and reagent receiving, logging in, assigning reagent/test article number working with QA
Research Data Coordinator
Urology San Antonio
San Antonio, TX
06.2018 - 02.2022
- Performs vital signs, blood collection, and patient visits under the supervision of a clinical research coordinator
- Resolves data queries on multiple electronic data capture systems
- Assists with screening potential patients to determine eligibility for current trials using the iSALUS EMR system
- Performs data entry for all ongoing clinical studies using various electronic data capture systems( iMedidata, iMednet,InForm, Medrio, IBM, etc.)
- Process all urine and blood samples for clinical studies
- Order/track all study supplies through Hybrent ordering system
- Maintain investigational product supply to ensure proper storage conditions
- Track expired investigational drug/supplies, dispose of properly, and order replacements as needed
- Review source documents to ensure completeness and accuracy per GCP/GLP regulations
Research Technician
USAISR
San Antonio, Texas
01.2018 - 05.2018
- Performs necropsy, tissue collection, processing, preservation, and carcass disposal on various animal species
- Provides instrumentation, surgical procedures, intensive care, and observation during recovery and surgical stages on various animal species
- Provides assistance with data entry and data review on all study/source documents
- Collects, processes, and stores biological specimens
Laboratory Analyst 1
PRA Health Sciences
Olathe, Kansas
04.2017 - 07.2017
- Performs data entry for multiple research trials
- Performs data review for quality control
- Identifying deviations and performing investigation under supervision
- Interpreting and data processing/reporting results
- Performs routine sample processing using multiple flow cytometry-based techniques
Laboratory Technician
Xenometrics
Stilwell, KS
02.2014 - 05.2016
- Provide QC of experimental data, records, and study containers
- Maintain pertinent records in compliance with SOPs, USDA, FDA, and AALAC regulations and guidelines
- Perform various animal dosing techniques such as oral gavage, oral capsules, subcutaneous and IV administrations
- Perform and collect various study requirements such as observations, food and water consumption and body weight
- Perform various biological sample collections procedures such as blood, urine, fecal and tissue samples
- Provide animal restraint and handling and perform animal identification
Education
Bachelor of Science - Agriculture
Kansas State University
Manhattan, KS12-2013
Skills
- GCP/GLP Regulations - 10 years
- GMP Regulations - 2 years
- EDC Systems - 4 years
- Microsoft Outlook - 10 years
- Microsoft Powerpoint - 10 years
- Microsoft Excel - 10 years
- Sample Management - 10 years
- Purchasing/Inventory Control - 10 years
- Animal Care/Handling - 2 years
- Preclarus - 2 years
- Suvoda - 2 years
- Veeva Vault eTMF - 2 years
- ICOLABS - 2 years
- Power BI - 2 years
- ICON iSite - 2 years
Timeline
Biosample Operations Specialist
ICON Strategic Solutions
05.2023 - 10.2025
Senior Research Associate
Scorpius Biomanufacturing
01.2023 - 05.2023
Clinical Sample Manager
Scorpius Biomanufacturing
02.2022 - 12.2022
Research Data Coordinator
Urology San Antonio
06.2018 - 02.2022
Research Technician
USAISR
01.2018 - 05.2018
Laboratory Analyst 1
PRA Health Sciences
04.2017 - 07.2017
Laboratory Technician
Xenometrics
02.2014 - 05.2016
Bachelor of Science - Agriculture
Kansas State University