- I participate in various sports activities such as cycling for physical activity, camaraderie, and personal growth
- Gardening
- Exploring famous landmarks, historical sites, and cultural attractions in a new destination
CHARLENE L. JONES, BSN, RN, MBA, CCRP
Clinical Research Operations Manager
INDIANAPOLIS
Summary
Clinical research and regulatory compliance professional with a proven track record in effectively managing complex operations. Skilled at optimizing processes and ensuring data integrity to drive impactful research initiatives. Recognized for strong team collaboration skills, consistent achievement of results, and adaptability to evolving project needs. Noted for problem-solving, strategic planning, and effective communication to successfully navigate industry challenges.
Overview
28
28
years of professional experience
3
3
Certifications
Work History
Clinical Research Operations Manager
FHI360
Durham, NC
03.2023 - Current
- Manage cross-functional study teams coordinating the staff conducting the day-to-day operations of multiple clinical trials including trial start-up, conduct, and close-out activities
- Develop and implement clinical operational plans, incorporating the study and scientific plan
- Oversee forecasting of technical, operational, and staffing resources
- Recommend and implement innovative process ideas to impact clinical trials management
- Develop and implement study materials, which may include protocols, informed consent documents, manuals of operation, quality management plans, clinical and safety monitoring plans and project management plans
- Provide general oversight of the electronic Trial Master File (eTMF) for assigned projects to ensure study document compliance for multiple clinical trials
- Identify risks and resolves issues within the clinical project, ensuring issue escalation
- Responsible for overall project or program risk development and maintenance
- Oversee the preparation for and participate in audits by study sponsors or other oversight bodies
- Establish and facilitate working groups and committees
Clinical Research Manager
Indiana University School of Medicine
10.2018 - 02.2023
- Contributed to the strategic management and planning within Krannert Cardiovascular Research Center through tactical process improvement initiatives and guidance document development
- Provided oversight and ensured effective screening and recruitment of research participants
- Fostered collaborative interdepartmental relationships with PIs, study teams., and hospital/ research center key personnel
- Ensured timely completion and submission of Regulatory documents
- Built and directed effective Investigator Initiated Trials and Industry Sponsored trial budgets
- Managed six research employees and three third-party contractors in the implementation of clinical trials
- Wrote and led the development of Clinical Trial protocols, Informed Consent documents, CRFs, INDs and Regulatory documents
- Ensured timely local and single IRB submissions and follow-up
- Worked closely with Regulatory Associate in the submission of INDs to the FDA and amendments to existing INDs
- Ensured timely annual reports were written and submitted for IND submissions
- Managed trials conducted at multiple locations, (2016-2020), under the same protocol, sometimes including participating centers that are outside of the university
Clinical Research Coordinator
Indiana University School of Medicine
02.2016 - 09.2018
- Project Managed and Implemented Hepatic phase 2 research studies
- Scheduled and/or coordinated pre-study site visits of sponsors
- Evaluated study protocol, study design and risk to subject populations
- Coordinated and conducted informed consent discussions with research participants
- Ensured swift documentation and PI communication of AES and SAEs throughout course of trials
- Data management: Data collection and entry into electronic Data Capture systems; Query resolution
- Institutional Review Board (IRB): Timely submission of documents and notification of deviations
- Complied with all policies mandated from ICH, FDA, and clinical trial agreement
- Ongoing development of strategies for clinical performance improvement
Manager, Clinical Pharmacology, Scientific Communications, Clinical Trials Implementation
Eli Lilly and Company
01.2008 - 01.2016
- Manager for in-house Scientific Communications writers across phase 1 and phase 2, Clinical Pharmacology/ Exploratory Medicine
- Implemented and managed $2.5million budget for Exploratory Medicine's Scientific Communications functional outsourcing
- Worked with External Sourcing to ensure key vendors and vendor products were available to Early Phase Research
- Collaborated with functional leadership to define policies and/or improve processes to deliver quality deliverables
Clinical Research Nurse/CRA/ Team Leader
Eli Lilly and Company
01.1997 - 01.2008
- Therapeutic areas of expertise: Cardiology, Endocrinology, Oncology, Auto Immune, Renal
- Ensured compliance with clinical trial protocol and study procedures
- Implemented and supported study start-up and protocol training to ensure all personnel working on the trial were trained prior to study implementation
- Assisted study team in randomization of study participants
- Collaborated cross-functionally with ADME, PK, study monitors, study sponsors to ensure clinical studies were implemented accurately and data was clean to enable Database lock
- Accurately utilized several direct data capture systems such as AS400, CPOS, InForm, and Alphadas
- Developed and Implemented Telemetry and ABP processes and monitoring
- Ensured accurate calibrations of ABP monitoring equipment and ECG processes and equipment
Education
Master's in Business Administration - MBA
Indiana Wesleyan University
Indianapolis, INBaccalaureate of Science - Nursing
Indiana University
Indianapolis, INSkills
Microsoft Office
Data Quality Management
Methodological Research Design
Specialized Knowledge
Regulatory Compliance Expertise
Clinical Research Proficiency
Research Project Management
Advanced Excel Skills
Process Optimization
Detail Orientation
Effective Project Management
Effective Written Communication
Clear Communication Skills
Certification
Echosens Fibroscan, 2016
Work Phone
317-274-0983
Accomplishments
- Supervised team of 10 staff members.
- Used Microsoft Excel to develop milestones tracking spreadsheets.
- Achieved timely FDA submissions by completing protocol and Informed consent document creation with accuracy and efficiency.
- Documented and resolved team interpersonal conflicts which led to employee disciplinary model being implemented and eventual team harmony.
- Collaborated with external NIH team in the development of BCG /TICE; Malaria, and West Nile Virus protocols. Two of these trials resulted in timely site activation with sites meeting enrollment goals.
Affiliations
- Society of Clinical Research Professionals
- American Heart Association
- Chi Eta Phi Nursing Sorority
- Sigma Theta Tau Nursing Sorority
- New Era Church
- The Elephant Community Gardens
- Boy Scouts of America
Interests
Timeline
Clinical Research Operations Manager
FHI360
03.2023 - Current
Clinical Research Manager
Indiana University School of Medicine
10.2018 - 02.2023
Clinical Research Coordinator
Indiana University School of Medicine
02.2016 - 09.2018
Manager, Clinical Pharmacology, Scientific Communications, Clinical Trials Implementation
Eli Lilly and Company
01.2008 - 01.2016
Clinical Research Nurse/CRA/ Team Leader
Eli Lilly and Company
01.1997 - 01.2008
Baccalaureate of Science - Nursing
Indiana University
Master's in Business Administration - MBA
Indiana Wesleyan University
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