Tracie M Jones
Columbia
Summary
Senior CRA with over 20 years' combined experience in clinical trials and pharmaceuticals. Immense familiarity with CRA functions, to include clinical monitoring and ensuring all quality control measures are met. Proficient in Phase II-IV of trials, subjects' triage and assessments, and maintaining an interpersonal approach with patient protection and guideline adherence at the forefront of operations.
Overview
33
33
years of professional experience
1
1
Certification
Work History
Senior CRA 1
IQVIA
06.2022 - Current
- Conducts comprehensive site monitoring visits, including routine monitoring, initiation, and close-out visits, ensuring strict adherence to GCP, study protocols, and regulatory requirements.
- Manages main protocols and sub-protocols for early development oncology studies, ensuring high-quality execution, adherence to study objectives, and timely milestone achievement.
- Expertly utilizes Amgen Spotfire tools for in-depth data analysis, tracking study progress, and optimizing site performance, leading to improved trial efficiency.
- Develop and implement effective site-level recruitment plans to meet enrollment targets and enhance study predictability, driving recruitment success and minimizing delays.
- Leads site initiation visits, delivering comprehensive protocol-specific training to site staff, establishing clear communication channels, and ensuring expectations were met and potential issues were promptly resolved.
- Reviews and verifies informed consent documentation for subjects with complex oncology treatment regimens.
- Manages regulatory submissions, approvals, CRF completion, and data query resolution, supporting smooth and uninterrupted study progression.
- Ensures accurate and timely documentation, including proper filing of site documents in the Trial Master File (TMF) and Investigator Site File (ISF), adhering to GCP and regulatory standards.
- Prepares detailed monitoring visit reports, follow-up letters, and action plans to address findings, ensuring compliance and supporting study documentation requirements.
- Works closely with cross-functional study teams to address challenges, troubleshoot issues, and drive successful project execution, contributing to the achievement of study milestones and timelines.
Clinical Monitor Associate (CMA)
Syneos Health
03.2021 - Current
- Over 14 years in a clinical research environment, including 1 year of oncology research, 13 years of endocrine, 9 years of respiratory, 8 years of cardiovascular, and 2 years of urology research. Site management of increasing capacity and responsibility ranging from study design, project management, IRB submissions, subject recruitment and management, site monitoring, to data management.
- Achievements:
- Performs remote monitoring and site management activities for Phase I-I clinical research to assess the progress of these projects at assigned sites and to ensure these projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirement
- Performs remote site qualification, site initiation, site monitoring calls, and close-out visits ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Develops a working knowledge and operates according to ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/Processes.
CRC, Site Manager
TLM Medical Services, LLC
07.2007 - 01.2021
- Coordinate clinical research trials and perform monitoring through quality control of charts for AES (adverse events), investigational product, and source verification. Negotiate budgets and execute contracts. Create source documentation, submit required IRB (Institutional Review Board) forms, perform query resolution and data entry, and complete regulatory paperwork in a timely manner. Conduct patient contact and recruitment, to include screenings, enrollment, phlebotomy, study drug administration, and assessment.
- Achievements:
- Perform as Primary CRC (Clinical Research Coordinator) on approximately 40 clinical trials throughout tenure, successfully training and overseeing additional CRCs while maximizing productivity.
- Exemplify requirements for patient's protection and IRB guidelines related to company sponsored and supported studies.
- Complete Informed Consent process following GCP (Good Clinical Practice) and process data specific to each research project.
- Recognized for ensuring comprehension of treatment plans and enforcing compliance to protocol as Patients, Physician, and Sponsor liaison by performing site initiation visits (SIV), monitoring visits (MV), and site closeouts.
- Implement effective monitoring strategies by understanding objectives, efficacy, and safety and ensuring effective risk mitigation for seamless clinical operations.
- Record of maintaining current certifications, such as from Norton Audits, on ICH (International Conference on Harmonisation)/GCP, SOPs (Standard Operating Procedures), and Clinical Research Coordinator tasks.
- Successfully assist Investigators by developing, implementing, and supporting the research process, building rapport, and exceeding contractual requirements.
Sales Consultant
Novartis Pharmaceuticals
01.2005 - 05.2007
- Promoted pharmaceutical drug sales by developing relationships with primary care physicians and cardiologists. Demonstrated one-on-one presentations, group discussions, and education programs on product.
Senior Staff Consultant
Peoplesoft, Inc.
03.1996 - 01.1998
- Managed major accounts, grew customer base, and established cross-functional relationships with high-level officials. Performed recruitment to consult on software contracts, configure files and databases, software upgrades, and new releases.
Program Analyst, Customer Support Technician
Dynamic Resources (Pentagon)
03.1993 - 12.1995
- Provided complex solutions through mainframe, server, and software to executive levels within commercial and public sectors. Allowed for new account growth and increased profitability by strategically identifying and pursuing critical opportunities.
Education
Master of Business Administration -
Webster University
Columbia, SC01-2004
Bachelor of Science - Computer Science
Tennessee State University
Nashville, TN01-1992
Skills
- ICH-GCP
- SDR Monitoring
- SDV Monitoring
- Data Management
- ETMF management
- ISF
- Creation
- SOP's
- Regulatory
- Microsoft Office
- Electronic data capture
- Site management
- Detailed documentation
- Informed consent process
- Adverse event reporting
- CTMS
Affiliations
- Society of Clinical Research Associates (SoCRA)
- Association of Clinical Research Professionals (ACRP)
Certification
- ICH/GCP certification
- IATA certification
Timeline
Senior CRA 1
IQVIA
06.2022 - Current
Clinical Monitor Associate (CMA)
Syneos Health
03.2021 - Current
CRC, Site Manager
TLM Medical Services, LLC
07.2007 - 01.2021
Sales Consultant
Novartis Pharmaceuticals
01.2005 - 05.2007
Senior Staff Consultant
Peoplesoft, Inc.
03.1996 - 01.1998
Program Analyst, Customer Support Technician
Dynamic Resources (Pentagon)
03.1993 - 12.1995
Bachelor of Science - Computer Science
Tennessee State University
Master of Business Administration -
Webster University
CLINICAL TRIAL EXPERIENCE
- Oncology (Early and Late Phase)
- Opthalmology (Phase III)
- Hypertension (Phase II–IV)
- Type II Diabetes (Phase II-IV)