Jacquelyn Ward
Euless,TX
Summary
To Obtain a position that allows me to use my medical research skills effectively to assist patients.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Site Operations Manager
Helios Clinical Research
Arlington, Texas
06.2024 - Current
- Directs supervises and evaluates work activities of all site staff
- Directs or conducts recruitment, hiring, training, and performance reviews of all site staff
- Develops and implements organizational policies and procedures for the facility
- Establishes work schedules and assignments for staff according to workload, space, and equipment availability
- Monitors study activities to ensure compliance with protocols and with all relevant local, state, and federal regulations and institutions
- QC/QA work of Clinical Research Coordinator
- Budget and Contract
- Help implement Study Start-ups
- QAPI Reports.
Clinical Research Coordinator
UT Southwestern
Dallas, Texas
08.2017 - 02.2023
- Reviewed new protocols and materials provided by Study Sponsors and Doctors
- Coordinated implementation of various protocols
- Helped ensure applicable study supplies, including study drugs and/or devices, were received before study initiation
- Maintained communication with the study sponsor and/or designee throughout the study
- Coordinated research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria met
- Reported serious adverse events (SAEs) promptly per study sponsor (or designee) and IRB requirements
- Assisted with Regulatory binders and Doctor n Sponsors communication.
Lead Senior Clinical Research Coordinator
Care Access
Boston, Massachusetts
07.2022 - 01.2023
- Out of state multiple weeks out of the month
- Submission to IRB
- Submitting Adverse Event Reports and Serious Adverse Event Reports
- Review and assess protocol (including amendments) for clarity, logistical feasibility, safety, and inconsistencies
- Attend Investigator meetings, coordinate and attend pre-study site visits
- Site initiation visits and monitoring visits with clinical staff and Sponsor/'CRO representatives
- Ensure education of Assistant CRCs, CRC is site staff and/or sub-investigators is completed for required tasks
- Integrate monitoring visits and study teleconferences into existing work schedules to allow for adequate preparation and time for interaction during the meeting
- Resolve data management queries and correct source data as needed
- Record protocol exemptions and deviations as appropriate with the sponsor
- Utilize and maintain Good Clinical Practices
- Maintain adherence to FDA regulations and ICH Guidelines
- Integrate new therapeutic, more complex trail load with existing trail load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timeline
- Maintain organized files for blank source documents
- Patient's charts, CRFs, and supplies
- IRB submissions and QC for studies.
Senior Clinical Research Coordinator
Ventavia Research
Arlington, Texas
02.2022 - 07.2022
- Enrollment/ Recruitment
- Coordinated implementation of various protocols
- Consenting subject to studies
- Blood drawn, processing, and shipping blood products
- Coordinating infant visits to RSV Studies
- IRB Submissions
- Submitting Adverse events and Serious adverse events
- Setting up meetings with doctors
- Community outreach for study
- Vital signs, EKG
- Charting
- Study drug inventory.
Clinical Research Coordinator
Baylor Health Care Heart Hospital
Plano, Texas
02.2015 - 08.2017
- Reviewed new protocols and other materials provided by Study Sponsors
- Provided input to Principal Investigator and Manager, as applicable, regarding clinical and research issues to determine financial and clinical feasibility
- Coordinated implementation of various protocols for assigned research projects with appropriate departments throughout Baylor Health Care System (BHCS) by interacting with Principal Investigators and Clinical Managers/Supervisors
- Provided in-service education for healthcare professionals and working with Pharmacy to ensure a smooth project flows
- Assisted with the preparation of Institutional Review Board (IRB) materials related to the initial review and approval of the study
- Assisted in the development of research study budgets for new clinical trials, and helped ensure that appropriate billing or charging mechanisms were in place for research charges related to the research study
- Helped ensure applicable study supplies, including study drug and/or devices, received prior to study initiation
- Developed, field tests and critiqued data collection form and offers suggestions for revisions
- Develop appropriate protocol information sheets and preprinted Physician Order sets for new investigational drug protocols and revises as indicated throughout the study period Seeks
- Multidisciplinary input in developing order sets
- Maintained communication with the study sponsor and/or designee throughout the study
- Reported serious adverse events (SAEs) promptly per study sponsor (or designee) and IRB requirements
- Assisted with regulatory compliance including assisting in preparing IRB materials for approval of protocol amendments, submitting Investigational New Drug (IND) Safety Reports to the IRB, completing IRB continuing review reports and assisting with drug accountability
- Coordinated study-monitoring visits
- Assisted with preparing Institutional Review Board final report
- Helped ensure that all study documents were complete and that records were retained per Federal, State and Institutional standards.
Clinical Research Coordinator
US Renal Care
Dallas, Texas
02.2010 - 02.2015
- Helped to manage all active trials for IRB submission and the ones returning patient updates and yearly approvals
- Assisted in reviewing and selecting trails for IRB submission
- Processed protocol documents including constructing narratives and informed consent documents
- Submitted all updated versions of the protocols and informed consent to the IRB
- Advised investigators of any protocol changes, dose modifications, required lab tests and radiological evaluations, and any other protocol changes/requirements
- Served as the liaison to the medical team, patients, and family to ensure proper conduct of the protocol
- Recognized, observed queries, and documented all adverse events
- Provided relevant information for determination of seriousness, grading, causality
- Implemented Intervention for protocols
- Accepted responsibility for the investigator's recommendation for the intervention
- Acquired responsibility for all follow-up documentation and submission to the proper authorities (Sponsor, Governmental agencies, and designated Institutional Review Board) regarding adverse events and Resolution of adverse events
- Maintained protocol regulatory files in compliance with IRB, FDA, OHPRR, and all pharmaceutical Specification
- Therapeutic Studies
- Vaccines
- Cardiology
- Neurology
- OB/GYN
- Nephrology
- Rheumatology.
Education
High School Diploma -
Lamar High School
Arlington, Texas01.1988
Pursuing a bachelor’s degree in nursing -
University of Phoenix
PhoenixBryan Institute
Arlington, TexasTarrant County College
TexasSkills
- Directing
- Supervising
- Evaluating work activities
- Recruitment
- Hiring
- Training
- Performance reviews
- Developing
- Implementing organizational policies
- Monitoring study activities
- Compliance with protocols
- Regulations
- QC/QA work
- Budgeting
- Contract management
- Study start-ups
- Submitting adverse event reports
- Serious adverse event reports
- Reviewing
- Assessing protocols
- Clarity
- Feasibility
- Attending investigator meetings
- Site visits
- Ensuring education
- Assistant CRCs
- Site staff
- Resolving data management queries
- Maintaining adherence
- FDA regulations
- ICH guidelines
- Integrating new therapeutic trials
- Existing workload
- Maintaining organized files
- Study documents
- Supplies
- IRB submissions
- QC for studies
- Enrollment
- Recruitment coordination
- Coordinating implementation
- Various protocols
- Obtaining subject consent
- Conducting visits
- Blood drawing
- Processing
- Shipping
- Setting up meetings
- Doctors
- Community outreach
- Vital signs
- EKG monitoring
- Charting
- Study drug inventory management
- Reviewing new protocols
- Materials
- Maintaining communication
- Study sponsors
- Reporting serious adverse events
- Assisting with regulatory compliance
- IRB materials
- Coordinating study-monitoring visits
- Ensuring completeness
- Record retention
Certification
Patient Care Technician Certification, 01/07
Timeline
Site Operations Manager
Helios Clinical Research
06.2024 - Current
Lead Senior Clinical Research Coordinator
Care Access
07.2022 - 01.2023
Senior Clinical Research Coordinator
Ventavia Research
02.2022 - 07.2022
Clinical Research Coordinator
UT Southwestern
08.2017 - 02.2023
Clinical Research Coordinator
Baylor Health Care Heart Hospital
02.2015 - 08.2017
Clinical Research Coordinator
US Renal Care
02.2010 - 02.2015
High School Diploma -
Lamar High School
Pursuing a bachelor’s degree in nursing -
University of Phoenix
Bryan Institute
Tarrant County College
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