Raquel Williams
Tucker,GA
Summary
Adaptive Clinical Research Professional dedicated to advancing the future of medicine through clinical research. My primary therapeutic expertise is in Oncology, more specifically, Solid Tumor, Leukemia, Lymphoma, Multiple Myeloma and Uterine(Endometrial)/Breast Cancer. I have the capacity to recognize recurring data issues and analyze the cause to reach a resolution. I can function independently with limited supervision and/or with a team. Initiative-taking and creatively driven to impact quality care of clinical trial subjects. With my knowledge in Oncology, I can certainly attribute quality results to your organization. I am thrilled to acquire new skills that will make me a valuable resource in the workplace. Additionally, I look forward to building and bridging the gap in health disparity while contributing to the culture of perpetual learning and meaningful collaboration.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator (Remote/Contracted)
Medasource
04.2024 - Current
- Follows clinical research protocols and conducts study visits in compliance with ICH/GCP and FDA regulations.
- Works with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Maintains a working knowledge of study guidelines, and investigational product data entry process, as applicable, documentation, and safety reporting per study guidelines.
- Coordinate and oversee clinical trial activities to ensure studies are completed on time and with high accuracy.
- Assesses patients' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Completes full follow-up with regard to missing information from stakeholders.
- Enhances patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Collaborates with clinical staff and other healthcare professionals to support clinical trial data accuracy
- Documents study-related information in the EDC system, manage data queries, and actively participate in monitoring visits.
- Reduces data entry errors by implementing stringent quality control measures throughout the study lifecycle.
- Escalates potential problems or issues that require management's immediate attention.
Patient Recruitment Specialist
Alcanza Clinical Research
01.2024 - 04.2024
- Acted as the primary contact for new and existing patients, orchestrating appointments, and addressing study-related inquiries.
- Managed approximately 80+ outbound calls a day.
- Employed the company's screening process to recruit and pre-screen study participants.
- Contributed to study enrollment goals by cross-screening patients for multiple studies.
- Understood and applied study protocol criteria, visit schedules, and compensation guidelines.
- Conducted pre-screen conversations utilizing sponsor/trial specific pre-screen questionnaire to evaluate potential eligibility for a clinical trial.
- Scheduled eligible patients for on-site visits, meticulously documenting transportation or special accommodation needs.
- Maintained confidentiality of patient protected health information.
- Ensured compliance with FDA/GCP/HIPAA guidelines.
Clinical Research Data Coordinator
Actalent
06.2023 - 11.2023
- Ensured all protocol procedures and ordered and completed as specified by protocol.
- Abstracted data from the medical record and completes paper and electronic CRFs including responding to any requests for data clarification.
- Optimized the safety of research subjects by ensuring any adverse events (AE) are appropriately reported to the sponsor, study team and institution according to protocol and regulatory requirements.
- Point person to receive AE notification from study team and ensures AE is followed up and/or resolved, as applicable.
- Scheduled and participated in interim monitoring visits (IMV) for source data verification (SDV).
- Reviewed monitoring reports for assigned studies, determines any discrepancies, and resolves outstanding data issues identified by the monitor.
- Ensured all patients, for assigned studies, are entered into the CTMS according to COH policies and status is correct.
- Assisted Clinical Research Billing (CRB) with resolving outstanding data issues or inquiries for financial concerns.
- Participated in the validation of the Epic treatment plans and CTMS calendars for assigned studies.
- Sorted and processed incoming reports before putting data into processing software.
CLINICAL RESEARCH DATA COORDINATOR
Winship Cancer Institute, Emory University
05.2021 - 06.2023
- Served as lead Data Coordinator of 8 Cellular Therapy assigned studies while developing strong working relationships across departments to resolve data issues.
- Worked with principal investigator(s) and sponsors to facilitate daily trial activities and comply with research protocols.
- Executed and coordinated daily clinical research activities according to CRA's, CRC's, SOP's, GCP's, and NIH/ICH guidelines.
- Reviewed and analyzed information from medical records (clinic notes, pathology reports, radiology reports patient questionnaires, etc.).
- Independently responsible for all aspects of clinical data management including creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events.
- Accurately captured and entered data into clinical trial databases as necessary, and within timeliness set by study Sponsors and/or CTO.
- Reviewed CRF completion guidelines, monitoring plans and clinical monitoring reports for accuracy and completeness.
- Presented CRF and Discrepancy Management at Investigator Meetings when requested.
- Completed Soft Lock and Hard Lock of the database prior to the completion of the study after rigorous QC of data.
- Ensured the timeliness of projects for clinical trials from Study Start-Up to Close Out.
- Prepared, collected, and ensured all data is available prior to pharmaceutical representative for CRO visit.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
TAX EXAMING TECHNICIAN
Internal Revenue Service, IRS
08.2020 - 01.2021
- Requested and reviewed taxpayers' records to verify claims and resolve inquiries that occurred during initial review.
- Processed tax payments, set up payment plans and worked with delinquent taxpayers to resolve issues.
- Researched corrective actions to close a case, such as adjusting taxpayer's account, recomputing tax liability, and preparing manual refunds with 98% accuracy.
- Detected violations of tax law and cases requiring examination determinations or legal determinations of the tax codes.
- Sent correspondence to resolve auditing issues from non-compliance to verify by supplying documentation.
- Communicated results of audits to taxpayers and taxpayers' representatives.
- Organized work to meet demanding production goals.
CASE WORKER, DISASTER RELIEF MEMBER
Red Cross
06.2019 - 05.2020
- Collaborated with team members to prevent and prepare for emergencies/disaster relief.
- Educated and conducted over 200 community members on fire disaster relief and how to prepare for natural disasters.
- Approached issues proactively to best meet current and future community needs.
- Utilized evidence-based practices to provide effective interventions for clients.
- Assessed and evaluated clients' needs, determined eligibility for services, and developed individualized plans.
- Created report of findings and presented to supervisor at close of internship.
- Acquired deeper knowledge of how to interact with clients, appreciation for diverse cultures and perspectives, and a sense of one's responsibility to community and service.
- Maintained high level of client confidentiality, following strict guidelines, and recommendations.
Education
Bachelor of Science - Health Administration
Fresno State University
Clinical Research
Clinical Research Fastrack
Skills
- People Skills
- Critical Thinking
- Change Management
- Process Improvement
- Detail Orientation
- Data Analysis
- Clinical Trials Research
- Good Clinical Practice
- Regulatory Compliance
- Protocol Adherence
- Coachable
Certification
- HIPAA Certification, 2024
- Good Clinical Practice Certificate, 20234
- Mayo Clinic Dangerous Goods Training, 2024
- CPR/AED + First Aid Certification, 2024
Affiliations
- Member: College of Health and Human Services Honors Program
- Member: University Student Union Board of Directors
- Nominated for the President's & Dean's Medalist Award for the College of Health & Human Services
- Question. Persuade. Refer. (QPR) Institute – Suicide Prevention
- Central California SPCA Volunteer
Timeline
Clinical Research Coordinator (Remote/Contracted)
Medasource
04.2024 - Current
Patient Recruitment Specialist
Alcanza Clinical Research
01.2024 - 04.2024
Clinical Research Data Coordinator
Actalent
06.2023 - 11.2023
CLINICAL RESEARCH DATA COORDINATOR
Winship Cancer Institute, Emory University
05.2021 - 06.2023
TAX EXAMING TECHNICIAN
Internal Revenue Service, IRS
08.2020 - 01.2021
CASE WORKER, DISASTER RELIEF MEMBER
Red Cross
06.2019 - 05.2020
Bachelor of Science - Health Administration
Fresno State University
Clinical Research
Clinical Research Fastrack
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