Hi, I’m
LASHON HALL
Clinical Trial Manager
Overview
19
years of professional experience
Work History
Ultragenyx PharmaceuticalNovato, CA
Clinical Trial Manager
08.2023 - Current
Job overview
- Responsible for the day-to-day management of assigned operational aspects, such as CRO/vendor management, drug supply management, management of clinical sites, etc
- For assigned region(s) or study(s)
- Manages high impact vendors, including oversight of timelines and contracts (invoicing, purchase order monitoring, and forecasting)
- Oversee development and maintenance of study documents such as Study Timelines, Vendor Management Plan, Risk Management Plan, Informed Consent Form, Monitoring Oversight Plan, CRFs, Study Reference Manual, dashboards, etc
- Lead, or actively contribute to, Study Management Team meetings
- Identify study risks, develop and implement mitigation strategies
- Oversee Trial Master File, Completeness Reviews, and Essential Document List
- Support the study budgeting process, including the review of invoices and clinical trial financial accruals
- Serve as a subject matter expert on initiatives and working groups
- Mentors Clinical Operations Staff (Clinical Trial Associates, Specialists, CTMs), including onboarding of new hires
Ultragenyx PharmaceuticalNovato, CA
Clinical Trial Specialist
01.2022 - 08.2023
Job overview
- Actively involved in the performance of study feasibility assessments
- Develop and review study documents (e.g., site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms)
- Manage the collection, review and approval of regulatory documents from clinical sites
- Coordinate investigational product release activities across clinical sites
- Manages and tracks study specific payments
- Create study-specific site budgets
- Initiate, maintain and reconcile the Trial Master File
- Assists in the preparation of Investigator and Study Coordinator Meetings
- Set-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs
- Coordinate communication of tracking information within the study team and to the clinical sites
- Develop and review Standard Operating Procedures
- Serve as a subject matter expert for the CTS role on initiatives and working groups
- Mentor Clinical Trial Associates
- May be responsible for the following activities: Manage ancillary vendors, such as a specialty lab, Assist with study-specific training of Clinical Research Associates, Perform site initiation, routine monitoring and close-out visits at a limited number of clinical sites, as well as co-monitoring with Clinical Research Associates, Review site visit reports, under the direction of the Clinical Program Manager or designee, Negotiate aspects of study-specific site budgets
Parexel BioTechDurham, NC
Laboratory Logistics Coordinator
09.2020 - 12.2021
Job overview
- Assigns study task to Laboratory Logistics Leader, Logistics Project Specialist and Laboratory Logistics Assistants
- Process Quality Management (QM) queries
- Process Procurement study orders
- Vendor Management (Third party vendors such as laboratories, courier services providers, sponsors and clinical sites)
- Create essential project documents
- Coordinates regional and global project teams
- Functional review of external costs and service fees
- Over responsibility for sample logistics, sample processing and reporting
- Coordinates development of required study documents and systems according to given timelines and resources
- Manages day to day communication with 3rd party provider and supports negotiation of scope of work
Parexel BioTechDurham, NC
Clinical Logistics Coordinator
Job overview
- Manage slot assignment
- Facilitate the review and approval of patient screening and enrollment
- Coordinate patient scheduling for leukapheresis, chemo conditioning and IP infusion
- Liaise with manufacturing on product receipt and IP shipment
- Arrange courier pick-up of both IP and leukapheresis product
- Point of contact for compliance issues with IP and temperature deviation
- Conduct site training during SIV
Chiltern (acquired by Covance)Durham, NC
Senior In-House Clinical Research Associate
01.2016 - 09.2020
Job overview
- Assist CRAs with preparation for site visits (i.e
- Running reports, QC of files (checking for missing documents), resolving action items from previous visits)
- Perform CRF review, query generation and resolution against established data review guidelines, on Covance or client data management systems, as assigned by management
- Assist CRAs with General On-Site Monitoring Responsibilities: PSVs, SIVs, RMVs and COVs and act as a co-monitor for on-site RMVs as needed
- Perform remote and onsite visits (i.e
- Phone PSVs, phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan, including remote monitoring that includes SDV when sites provide remote access to their EMR
- Conducted IVRS/IWRS review and reconciliation, ensured data was accurate and up to date
- Conducted in-house EDC review, query resolution, and data entry reconciliation
- Liaise with local or central laboratories to ensure adherence to the protocol, ensuring that all relevant documentation is current e.g., accreditation certificates, normal ranges, etc
- Conduct site training as needed via phone, onsite and/or teleconference/web meeting
- Conduct IVRS/IWRS review and reconciliation, ensuring that data is accurate and up to date
- Liaised with data management regarding data flow and data query processing
- In-House CRA Consultant for Decentralized Clinical Trials for internal teams on training material
- To serve as a mentor to less experienced In-House CRA staff
Chiltern (acquired by Covance)Durham, NC
Lead Logistics Coordinator
Job overview
- Assisted in creating sample management dashboard for sponsors
- Assisted in creating study documents for logistics e.g., logistics sample shipment checklist, internal chain of custody, logistics responsibility/process manual, logistics coordinator training module, training manual and slides for onboarding new hires
- Assigned as a vendor expert to the vendor management team
- Logistics Cell/Gene Therapy Consultant for internal teams on sample shipments and requirements
- Created excel spreadsheets for sample tracking per protocol sample collection schedule for logistic coordinators
- Assigned to the bid defenses team for strategy in presenting logistics to potential new clients
- Assigned to the Cell and Gene Therapy Group to improve the organizing, consistency, training, streamlining and communication of Cell Therapy / CAR-T capabilities
- Primary contact of sample shipments for assigned sites, conduct site phone/onsite SQVs, SIVs, SMVs and COVs, and attend co-SMVs as needed
- Provided site training as needed via phone, onsite and/or web meetings
- Monitored site performance and implement action plans for sites not meeting expectations, in conjunction with the protocol, lab manual, Investigator Brochure, ect
- Work with the site on discrepancy management and re-educate as needed on proper sample collection and shipping procedures
- Liaise with the CTA and CRA to distribute and track clinical trial supplies, e.g
- CRFs, study medication, lab kits, delivery and return of lab equipment
- Primary contact for coordination of shipment of drug and laboratory samples, clinical trial supplies to ensure sites have sufficient supplies to continue recruitment
- Liaised with sponsor/medical monitor regarding clinical questions and study status
- Mentor less experienced Logistic Coordinators
Ameritox Medication Monitoring SolutionsGreensboro, NC
Senior-LC/MS/MS Operator (Medical and Clinical Trials)
06.2013 - 01.2016
Job overview
- Analyzed urine and oral fluids using liquid chromatography mass spectrometry (LC-MS) and gas chromatography mass spectrometry (GS-MS)
- Performed Analysis and maintenance Agilent, Waters and AB Sciex instruments
- Tracked samples from clinical trial sites through mass links and worked with shipping vendors to ensure shipment of samples arrived as planned
- Verified samples against requisition form, collected the sample ID number and converted into barcode prior to processing
- Trained new hires and lab assistance on all laboratory procedures such as processing and prioritizing critical samples, data review and calibration of Agilent, Waters instruments and solvents
- Troubleshot any discrepancies by checking patient medications, screening, and data comparisons from any past testing to assist the Certifying Scientists in reporting accurate results
- Conducted second review of lab results prior to Certifying Scientists final review
- Verified and/or analyzed urine and oral fluids samples before chromatography evaluations could be completed
- Determined accuracy and consistency in data to release results
- Problem solved laboratory incidents to determine the root cause involving QA/QC
- Problem solved instrumentation aliquot and/or extractions processes to improve daily production effectively and efficiently
Aerotek ScientificGreensboro, NC
Lead-GMP Quality Control Technician III
03.2012 - 06.2013
Job overview
- Supervised and performed analytical testing such as sterility, endotoxin, cell viability using Flow Cytometers, Biosafety Cabinets, Microscopes, BacT/ALERT 3D Sterility and data collection software to archive results in NextDocs and Blue Mountain Regulatory Asset Manager
- Created and supervised routine workflow processes for non-routine analysis of consumables/reagents, in-process, and finished products according to approved GMP and GLP regulations
- Executed and reviewed all performance testing and data of environmental monitoring activities to help maintain regulatory requirements for microbial and particulate counts in the GMP and all ISO facilities
- Wrote, reviewed and/or revised SOPs and all data documents to support internal Quality Control audits for deviations, CAPA resolutions, validation documents, data systems and technical issues
- Developed, wrote, implemented SOP methods and procedures for internal and/or external inspections, testing, evaluations of cell identity and reproducibility of the products
Laboratory Corporation of AmericaBurlington, NC
Specialist Chemistry Technologist (Medical and Clinical Trials)
03.2006 - 06.2012
Job overview
- Detected and identified monoclonal gammopathy (M protein) found on serum protein by using electrophoresis; interpreted and characterized dysgammaglobulinemic states using electrophoresis on serum and urine
- Tested validation applications on, Helena SPIFE 3000 Electrophoresis and performed daily and routine maintenance activities on instruments including calibrations, quality control checks, blind studies and instrument performance evaluation
- Detected and identified the M protein found in serum protein by using electrophoresis
- Interpreted and characterized dysgammaglobulinemic states using electrophoresis in serum and urine
Mendenhall Clinical Research CenterHigh Point, NC
Lead Laboratory Technologist (Phase I Clinical Trial Unit)
05.2009 - 02.2011
Job overview
- Developed and monitored the Performance Improvement Plan for the laboratory and clinical operations
- Assisted in identifying issues that affected patient care and developed corrective plan of action
- Conducted quality improvement testing on technique performance improvement activities and target outcomes for clinical services and operations to ensure excellent care for patients in accordance with the company's strategic plan, clinical practices, quality improvement and productivity standards
- Evaluated laboratory deviations implemented CAPA resolutions
- Previous daily maintenance involving control checks and parallel readings for the YSI (glucose and lactate) and client DCA 2000 (A1c) analyzers
- Oversaw all shifts for data entry, batching, aliquot, labeling, scanning, filing of documents and maintaining compliance to ISO 9001/EN 46001 13485 of the facility
Summary
Thorough team contributor with strong organizational capabilities. Experienced in handling numerous projects at once while ensuring accuracy. Effective at prioritizing tasks and meeting deadlines. Organized, dependable and willingness to take on added responsibilities to meet team goals.
Skills
- Results-oriented
- Study design
- Protocol development
- Training and mentoring
- Clinical operations
- Good clinical practices
- Leadership skills
- Teamwork and collaboration
- Team building
- Project management
- Effective communication
- Trial oversight
Timeline
Clinical Trial Manager
Ultragenyx Pharmaceutical
08.2023 - Current
Clinical Trial Specialist
Ultragenyx Pharmaceutical
01.2022 - 08.2023
Laboratory Logistics Coordinator
Parexel BioTech
09.2020 - 12.2021
Senior In-House Clinical Research Associate
Chiltern (acquired by Covance)
01.2016 - 09.2020
Senior-LC/MS/MS Operator (Medical and Clinical Trials)
Ameritox Medication Monitoring Solutions
06.2013 - 01.2016
Lead-GMP Quality Control Technician III
Aerotek Scientific
03.2012 - 06.2013
Lead Laboratory Technologist (Phase I Clinical Trial Unit)
Mendenhall Clinical Research Center
05.2009 - 02.2011
Specialist Chemistry Technologist (Medical and Clinical Trials)
Laboratory Corporation of America
03.2006 - 06.2012
Clinical Logistics Coordinator
Parexel BioTech
Lead Logistics Coordinator
Chiltern (acquired by Covance)
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