- Youth mentor, providing guidance and support to empower the next generation of leaders
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- I enjoy helping others and giving back to the community
Courtney Hall
Lockhart,USA
Summary
Senior Clinical Research Associate II with over 10 years of experience in the clinical research and pharmaceutical industry, including 5 years as a Clinical Research Associate, 1 year as a Principal Clinical Trial Coordinator Lead, and 5 years as a Project Assistant.
Experienced leader, as a Sr. CRA II, with a strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence. Serves as point person for remote CRA team in executing research projects and disseminating findings to leadership. Displays strong written and oral communication skills to present complex analyses effectively. Cross functionally collaborates with remote site monitors, on-site monitors, Clinical Team Managers, and Project Managers on strategy and process improvement to increase compliance with regulatory document review and data stewardship across multiple systems.
Overview
11
11
years of professional experience
Work History
REMOTE Sr. CRA II
THERMO FISHER SCIENTIFIC
08.2024 - Current
- Remote Senior Clinical Research Associate II on a double-blind phase III study in Secondary Hyperparathyroidism in individuals with end stage kidney disease on hemodialysis
- Serves as the primary site contact from study start up through close out and maintains regular site staff contacts, trainings, and query resolution support
- Demonstrates an understanding of the disease from diagnosis through progression
- Knowledgeable about standard of care and treatment approaches per protocol with strong understanding of the study as well as project-level knowledge of the disease area under investigation
- Performs and coordinates tasks related to combined Pre-Study Visits and Site Initiation Visits and has oversight of site start-up activities during pre-activation phase to identify, escalate and mitigate any risks to site activation
- Performs remote monitoring activities including continual review of clinical data, investigation of trends, and determination of appropriate action for risk mitigation
- Completes actions driving improved data currency to ensure protocol, regulatory, and SOP compliance and to guarantee subject safety, data integrity, and site compliance
- Performs Remote Initiation Events, Remote Monitoring Events (with 100% or reduced SDV)
- Reviews electronic regulatory documents and electronic Investigator files and ensures subject safety by overseeing timely and accurate AE/SAE reporting and follow-up
- Uses IVRS for IP set-up, accountability, and management
- Prepares work orders for On-site Site Initiation Events/ On-site Monitoring Events/ On-site Close-out Events for on-site monitors and manages assigned on-site CRAs assigned for compliance of assigned tasks
- Supports investigative sites in FDA and sponsor lead audits to provide responses and manage CAPA/sPIP implementation
- Acts as a study specific mentor to provide guidance to onboarding CRAs and support to the team via protocol specific monitoring tool creation, active CRA monitoring shadowing, study specific Lunch and Learn targeted topic presenter, and various other activities
REMOTE Senior CRA I
THERMO FISHER SCIENTIFIC
11.2023 - 08.2024
- Served as the primary site contact from study start up through close out
- Knowledgeable about standard of care and treatment approaches per protocol with strong understanding of the study as well as project-level knowledge of the disease area under investigation
- Performs and coordinates tasks related to combined Pre-Study Visits and Site Initiation Visits and has oversight of site start-up activities during pre-activation phase to identify, escalate and mitigate any risks to site activation
- Performs remote monitoring activities including continual review of clinical data, investigation of trends, and determination of appropriate action
- Completes actions driving improved data currency to ensure protocol, regulatory, and SOP compliance and to guarantee subject safety, data integrity, and site compliance
- Performs Remote Initiation Events, Remote Monitoring Events (with 100% or reduced SDV)
- Reviews electronic regulatory documents and electronic Investigator files and ensures subject safety by overseeing timely and accurate AE/SAE reporting and follow-up
- Uses IVRS for IP set-up, accountability, and management
- Triggers On-site Site Initiation Events/ On-site Monitoring Events/ On-site Close-out Events
Senior CRA I
THERMO FISHER SCIENTIFIC
10.2022 - 11.2023
- Acted as Senior Clinical Research Associate on a double-blind phase III study in primary IgA Nephropathy and double-blind phase III study in Secondary Hyperparathyroidism
- Performed monitoring activities onsite from start up through maintenance in close collaboration with the Remote CRA including IP accountability, Investigator Site File review and source data review and verification through sponsor specific systems
- Conducted on-site sponsor attended Site Initiation Visits and remote refresher SIV’s to assist and accommodate investigator sites during start-up phase
- Updated systems and tracked activity in real time to facilitate monitoring team collaboration to ensure protocol, regulatory and SOP compliance and to guarantee subject safety, data integrity and site compliance
- As an Onsite CRA, developed collaborative relationships with investigational sites and ensured site audit readiness
- Built relationships with site staff while onsite, complementing and supporting effective remote interactions that a site will have with the remote CRA as their primary contact
- Acted as the Onsite CRA as the ‘site expert’ understanding site-specific processes, site staff dynamics and patient pathways
- Demonstrated an understanding of the project-level processes and requirements necessary for the targeted disease and patient population under investigation
- Implemented, and assisted with resolution of sPIP procedures for an investigative site per SOPs
- Attended remote and in person investigator meetings to assist with training, patient recruitment collaboration, and team building
CRA II
THERMO FISHER SCIENTIFIC
08.2021 - 10.2022
- Acted as blinded/unblinded CRA, main and co-CRA on two, phase I/II and III, double-blind, partially blind, Vaccine (COVID-19, Influenza) clinical trials in adult population
- Conducted on-site and remote SIV, COV and IMV with reduced SDV in accordance with the protocol and AIM sampling
- As unblinded CRA conducted full IP accountability, management, and destruction oversight including review and updates to IVRS system
- Supported sites in preparation for database lock
- Collected, reviewed, and filed all essential documentation
- Provided ongoing site training, supported with query resolution
- Participated in an investigator site audit as a co-CRA
- Performed management of related unblinded documents and safeguarded maintenance of blinding (email and phone communications and filing of documents in eTMF)
Clinical trial coordinator – Lead
THERMO FISHER SCIENTIFIC
04.2019 - 07.2020
- Delivered clinical trial project-related tasks according to budget, quality, and timelines, including increasing site and monitoring efficiency through timeline management of study documents in eTMF, and remote resolution of findings
- Performed PPD investigator file reviews and logged outstanding issues in project tracking tools and application clinical systems
- Liaised with RSM/CRA and investigative sites to resolve site level outstanding regulatory issues and helped to identify risks
- Managed and guided onboarding CTCs in task allocation, developmental trainings, and completion of assigned project responsibilities
- Created and revised trainings for multiple roles (Remote Site Monitor, CTC-Local, and Clinical Research Associates) within clinical administration through Lunch and Learn and the North America Business Trainer group to further enhance employees’ knowledge and efficiency in performing day to day tasks and effectively collaborating with other functional groups to further the company’s business objectives and culture
- Managed resourcing allocations in Clarity according to study budget
- Created meeting agendas, recorded meeting minutes, and lead calls for study, and internal team calls
- Managed and submitted Adverse Events and Serious Adverse Events to Central IRB’s when required by Sponsor
- Liaised with vendors like Inform, Sensonics, and Cenduit for site staff access, reporting, and urgent study deliverables
Senior project assistant
THERMO FISHER SCIENTIFIC
04.2018 - 04.2019
- Provided administrative and technical support to Project Teams
- Coordinated responsibilities of project administration as applicable to client contracts under direction
- Managed procedures and guidelines from different sponsors and monitoring environments
- Responsibilities included but were not limited to issuing feasibility questionnaires, building sites within CTMS database, performing file reviews, preparing project meeting minutes, mass mailing and communication to sites, processing regulatory and other study specific documents, entering quality data, reviewing, and updating document metrics and findings, updating and maintaining vendor trackers and maintaining data repositories
project assistant II
THERMO FISHER SCIENTIFIC
04.2015 - 04.2018
- Provided administrative and technical support to Project Teams
- Coordinated responsibilities of project administration as applicable to client contracts under direction
- Responsibilities included but were not limited to performing file reviews, preparing project meeting minutes, mass mailing and communication to sites, processing regulatory and other study specific documents, entering quality data, reviewing, and updating document metrics and findings, updating and maintaining vendor trackers and maintaining data repositories
project assistant
THERMO FISHER SCIENTIFIC
03.2014 - 04.2015
- Provided administrative and technical support to Project Teams
- Coordinated responsibilities of project administration as applicable to client contracts under direction
- Managed procedures and guidelines from different sponsors and monitoring environments
- Responsibilities included but were not limited to performing file reviews, preparing project meeting minutes, mass mailing and communication to sites, processing regulatory and other study specific documents, entering quality data, reviewing, and updating document metrics and findings, updating and maintaining vendor trackers and maintaining data repositories
Education
BA. - Communication in Rhetorical and Cultural Studies
St. Edwards University
Austin, Tx07.2012
Skills
- Leadership
- Conflict resolution
- Good clinical practice
- Regulatory compliance
- Coordinating supplies
- Protocol development
- Site management
- Patient recruitment strategies
- Monitoring visits
- Study design
- Interdepartmental collaboration
- Research and development
- Patient safety
Candidate
Courtney Hall, 832-452-7339, 1615 Twin Island Dr, Lockhart, TX, 78644, Senior Clinical Research Associate with more than 10 years of experience in the clinical research and pharmaceutical industry in various positions: 1 year of experience as a Remote Clinical Research Associate overseeing assigned on-site CRAs, 3 years of experience as an on-site Clinical Research Associate, 1 year of experience as a Principal Clinical Trial Coordinator Lead, and 5 years of experience as a Project Assistant directly supporting assigned project managers., CRA, Performed all types of on-site and remote Monitoring Visits: PSV, SIV, IMV and COV with 100% or reduced SDV. Coordinated and oversaw all clinical aspects for assigned sites from start-up to close-out., Principal Clinical Trial Coordinator, Lead the NA Business Training unit for onboarding company staff. Collaborated with remote site monitors, on-site monitors, Clinical Team Managers, and Project Managers on strategy and process improvement., BA., Communication in Rhetorical and Cultural Studies, St. Edwards University, Austin, TX, USA, 07/01/12, Vaccines Academy Certificate Program, 2022, PPD Hematology and Oncology Academy Certificate Program, 2020, THERMO FISHER SCIENTIFIC, Lockhart, TX, USA, REMOTE Senior CRA II, 08/01/24, PRESENT, Remote Senior Clinical Research Associate II on a double-blind phase III study in Secondary Hyperparathyroidism., REMOTE Senior CRA I, 11/01/23, 08/01/24, Served as the primary site contact from study start up through close out., Senior CRA I, 10/01/22, 11/01/23, Acted as Senior Clinical Research Associate on a double-blind phase III study in primary IgA Nephropathy., CRA II, 08/01/21, 10/01/22, CRA I, 07/01/20, 07/01/21, Clinical trial coordinator – Lead, 04/01/19, 07/01/20, Senior project assistant, 04/01/18, 04/01/19, Project assistant II, 04/01/15, 04/01/18, Project assistant, 03/01/14, 04/01/15, PPD CRA Academy, 07/01/20, Clinical Foundation Program and CRA procedure document training, 07/01/20, English, English, Endocrinology/Metabolic Diseases: Secondary Hyperparathyroidism, End Stage Kidney Disease, Rare/Genetic Diseases/Disorders: IgA Nephropathy, Vaccine: COVID-19, Influenza, and Cancer Vaccine (Immunotherapy), Hematology/Oncology: Myeloma, Large B-Cell Lymphoma, Hepatocellular Carcinoma, Metastatic Triple-Negative Breast Cancer, Acute Myeloid Leukemia, and Non-Small Cell Lung Cancer, Neuroscience: Schizophrenia, Prodromal Alzheimer’s Disease, and Generalized Myasthenia Gravis, Investigator Site Audit per sponsor, attended as Co-Monitor, EDC (Medidata RAVE), CTMS, eTMF, eDiaries, ePIP, MS Office (Word, Excel, PowerPoint, Outlook, OneNote, Skype Business, Microsoft Teams, SharePoint, OneDrive, Yammer), IVRS/IWRS (Almac, RAVE), EMR (CRIO)
Interests
Timeline
REMOTE Sr. CRA II
THERMO FISHER SCIENTIFIC
08.2024 - Current
REMOTE Senior CRA I
THERMO FISHER SCIENTIFIC
11.2023 - 08.2024
Senior CRA I
THERMO FISHER SCIENTIFIC
10.2022 - 11.2023
CRA II
THERMO FISHER SCIENTIFIC
08.2021 - 10.2022
Clinical trial coordinator – Lead
THERMO FISHER SCIENTIFIC
04.2019 - 07.2020
Senior project assistant
THERMO FISHER SCIENTIFIC
04.2018 - 04.2019
project assistant II
THERMO FISHER SCIENTIFIC
04.2015 - 04.2018
project assistant
THERMO FISHER SCIENTIFIC
03.2014 - 04.2015
BA. - Communication in Rhetorical and Cultural Studies
St. Edwards University
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