Microsoft Office
Elliott Jones
Senior Clinical Trial Lead
Summary
Experienced and dedicated individual with comprehensive knowledge in the research industry. Individual contributor with an eagerness to learn, develop, and grow in a dynamic environment. Strictly adheres to all company and ICH-GCP guidelines, regulations, and study protocols with diligent attention to detail for optimal end results. Works well in a team environment and can handle multiple projects and responsibilities at once. Eagerness to further education in the research industry and in all endeavors in life.
Overview
10
10
years of professional experience
4
4
years of post-secondary education
1
1
Certification
2
2
Languages
Work History
Senior Clinical Trial Lead
Sarah Cannon Research Institute
09.2023 - Current
- Expert in clinical project management with an extensive background in clinical research, project management, and expert knowledge of ICH-GCP, and applicable Federal and international research guidelines and regulatory requirements
- Works closely with the Project Manager to facilitate collaboration within Sarah Cannon Development Innovations project teams, research sites, and clinical trial sponsors to achieve project objectives and mutual goals
- Ensures that all clinical tasks meet client and Sarah Cannon expectations and are completed in accordance with the contract, protocol, project plans, ICH-GCP guidelines, and applicable Standard Operating Procedures (SOPs)
- Provides leadership in the development and execution of clinical trials by overseeing the clinical project management and operational responsibilities essential to successful development and execution of multiple assigned complex clinical research trial projects
- Provides proactive and continuous assessment of project needs for clinical resource forecasting to ensure timelines and deliverables are met while adhering to quality standards and supporting financial targets
- Plans and tracks clinical activities throughout the lifecycle of assigned study projects
- Proactively identifies and presents project-related risks and facilitate resolutions both in and across functions
- Creates and maintains Clinical Project Documents, including but not limited to clinical study plans, trackers, and team training materials
- Develops and conducts study team training
- Reviews performance metrics for assigned CRA team, including but not limited to site visit reports and other clinical study deliverables
- Manages enrollment and, as applicable, slot allocation for sites assigned to designated trial
- Works directly with data management and project team to facilitate timely data entry and cleaning
- Initiates improvements, tools, and forms to enhance the efficiency and quality of the work performed on assigned projects
- Creates a variety of reports, documents, training tools, and correspondence as needed to assist participating trial sites and for internal purposes in the ongoing monitoring and evaluation of project progress
- Identifies, addresses, and, as applicable, escalates clinical study risks and/or issues to facilitate resolution
- Provides oversight of Investigator Site File in the TMF/eTMF and performs inspection readiness per SOP
- Assists with vendor management, as applicable per study contract
- Reviews monitoring reports and tracks ongoing action items to ensure timely follow up by CPA and CRA
- Conducts CRA, sponsor, and team meetings as needed
- Ensures awareness of project-specific quality and performance standards and confirms that these are adequately documented, communicated, and understood
Site Relationship Partner (Sr. Manager)
Pfizer
01.2022 - 09.2023
- Partners with investigator sites through site identification, activation, start-up, conduct and close-out and drives execution to the right plan
- Deploy GSSO targeted site strategies by qualifying and activating targeted sites
- Lead Study Start-Up activities at the site level, including management of issues that may compromise time to site activation and enrollment
- Lead effective site recruitment planning and implementation of plans at the site level
- Monitor and support study start-up activities including review of key documents (e.g., local informed consent document templates)
- Provide enrollment support and partner with study team to define and support recruitment initiatives at site level
- Act as the main point of contact for all site and study questions, requiring attendance at protocol training and Investigator Meetings
- Identify and implement process improvements at a site level
- Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices
- Oversee local CRO representatives
- Develop positive Investigator relationships throughout the life of the study and beyond
Lead CRA
CATO-SMS
11.2021 - 01.2022
- Manages all clinical operational and quality aspects of allocated project specific requirements, may assume Lead CTM responsibilities on a regional level; e.g. process improvements, manage complex programs, have wider management of project coordinator responsibilities
- Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan for providing clinical related documents. Participate in the design and development of CRFs, CRF guidelines, patient Informed Consent templates
- Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies
- Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements
Sr. CRA/CTM-In-Training
Worldwide Clinical Trials
05.2019 - 10.2021
- Perform feasibility studies for potential sites as requested
- Conduct Pre-study, study initiation and interim monitoring visits in adherence to protocol requirements
- Function in the role of Lead CRA for global studies, coordinating CRAs
- Develop Clinical Monitoring Plan
- Design study specific tools and templates
- Actively participate in bid defenses
- Create and conduct training to study team members or colleagues
- Document site visit findings via written reports.
- Create preventative action plans for non-compliant sites
- Conduct risk based monitoring based on risk evaluation
- Conduct accompanied site visits for assessment or training of other CRAs
Clinical Research Associate II
Syneos Health
04.2018 - 05.2019
- Perform feasibility studies for potential sites as requested
- Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
- Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
- Document site visit findings via written reports Provide input into the design of protocols, CRFs and monitoring plans as requested
- Assess, monitor, and train study site staff on protocol adherence as required
- Ensure site compliance with IP receipt, accountability and return or destruction
Clinical Research Associate I
Syneos Health (Formerly InVentiv Health)
02.2016 - 05.2018
- Assess, monitor, and train study site staff on protocol adherence as required
- Review study subject safety information and informed consent
- Conduct source document verification for compliance, patient safety, and veracity of data
- Review CRFs using paper or electronic data capture systems Assist the site in maintenance of the Investigator Site File
- Maintain regular communication with sites
- Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
- Assist sites in data query resolution
- Ensure site compliance with IP receipt, accountability and return or destruction
- Complete final site close out visit and report
Monitoring Foundations Program Trainee
InVentiv Health
11.2015 - 01.2016
- Participated in a 12-week training program to acquire CRA skills.
Project Assistant
PPD
08.2014 - 10.2015
- Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and Client Company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory affairs and/or the client.
- Performed investigator file reviews and logged outstanding issues in project related tracking tools.
- Liaised with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner.
- Developed and maintained assigned data points within the CTMS database according to the established conventions and tools for the project, within specified timelines.
- Oversaw the execution and dissemination of study related information, including project tracking updates to clients, clinical study teams and other PPD departments.
Education
Bachelor Of Science - Microbiology
University of Texas At Austin
Austin, TX 08.2009 - 12.2013
Skills
Verbal and written communications
Safety standards and protocols
Knowledgeable in Microsoft Office
Vendor Management
CRO Management
Audit Conduct and Management
Risk Based Monitoring
Informed Consent Review
Protocol Deviation Management
Trip Report Review
ICH-GCP Principles
Additional Information
Therapeutic Experience
- Endocrinology
- Cardiovascular
- Hepatology
- General Medicine
- Dermatology
- Pulmonology
- Nephrology
- Oncology
- Infectious Disease
Software
CTMS
EDC
IRT/IVRS
ETMF
Certification
CRA Certification
Timeline
Senior Clinical Trial Lead
Sarah Cannon Research Institute
09.2023 - Current
Site Relationship Partner (Sr. Manager)
Pfizer
01.2022 - 09.2023
Lead CRA
CATO-SMS
11.2021 - 01.2022
CRA Certification
06-2019
Sr. CRA/CTM-In-Training
Worldwide Clinical Trials
05.2019 - 10.2021
Clinical Research Associate II
Syneos Health
04.2018 - 05.2019
Clinical Research Associate I
Syneos Health (Formerly InVentiv Health)
02.2016 - 05.2018
Monitoring Foundations Program Trainee
InVentiv Health
11.2015 - 01.2016
Project Assistant
PPD
08.2014 - 10.2015
Bachelor Of Science - Microbiology
University of Texas At Austin
08.2009 - 12.2013
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