Yarnick Mirjah
Orlando,USA
Summary
Highly skilled and experienced Quality Control Auditor and Data Manager, with 15+ years of experience on 26+ Oncology and 50 Neurological and General Medicine clinical trials. Knowledge in managing staff, monitoring data, reporting data discrepancies, abstracting and entering clinical research data for phase I, II, III & IV trials.
Quality control professional with robust background in auditing and compliance. Expertise in identifying and resolving quality issues, ensuring adherence to industry standards. Strong focus on team collaboration and achieving results, known for adaptability and reliability in dynamic environments. Skilled in data analysis and process improvement, with keen eye for detail.
Overview
16
16
years of professional experience
Work History
Quality Control Auditor
AES/PPD-Thermo Fisher Scientific
02.2019 - 07.2025
- Review draft informed consents, protocols, source documentation forms, by cross referencing protocol, lab manuals, annotated case report forms and Good Clinical Practice requirements.
- Conduct eligibility reviews on participant’s reported data and medical records via protocol Inclusion/Exclusion criteria to ensure qualified participants are enrolled.
- Perform post rando chart and e-source data reviews, on all study visits to ensure GCP (ALCOA) and protocol adherence, for audit/inspection readiness and participants safety.
- Confirm PI and Sub-Investigators oversight is present on source documents /records.
- Create, complete & utilize Quality Management Summary Reports & Key Quality Indicator Worksheets, to identify, detect, reduce and correct problem areas, trends, potential discrepancies /queries, and protocol deviations before monitoring visits, audits and inspections.
- Conduct one on one, Good Documentation and Good Clinical Practices training for new hires, seasoned research staff, Principal Investigators and Sub Investigator(s).
- Assist in data entry, query resolutions and database locks, ensuring that the data abstracted and entered is accurate and consistent.
- Strong ability to understand and interpret data management and monitor queries with resolutions in a timely manner.
- Organize and conduct periodic audits on regulatory Investigator Site File binders.
- Assist research staff, with Note to files, Protocol Deviation and CAPA(s) narratives.
- Collaborate and answer questions on a day-to-day basis regarding study specific concerns and issues.
- Manage the organization, shipping manifest and retrieval for closed and terminated studies to and from offsite storage facilities.
- Enhanced product quality by conducting thorough audits and identifying areas for improvement.
- Analyzed audit findings to identify trends and recommend process improvements.
- Trained staff on quality control protocols and best practices to promote adherence.
- Maintained detailed audit records and documentation to support regulatory compliance efforts.
Data Manager
AES/PPD Thermo Fisher Scientific
08.2016 - 07.2025
- Assist with data entry of phase I, II and III clinical trials from internal and external source documents.
- Abstract, enter and submit time sensitive data via electronic case report forms into Sponsor’s database and site database (e-Source).
- Work independently and directly with CRA to resolve manual and system generated queries to ensure data is accurate and in compliance with the protocol.
- Create and maintain a study specific query list for Research Coordinators for complex queries.
- Manage and assist PI in e-signing eCRFs for database locks.
- Upload & download eCRF casebooks / questionnaires to USB for storage after study closure.
- Assist in Regulatory documents maintenance.
- Neurology, Gen Med, Pain, Vaccine & Phase 1 Clinical Trials
- Mentored junior staff on best practices in data collection, analysis, and reporting techniques.
- Collaborated with cross-functional teams to identify data needs, ensuring alignment with business objectives.
- Trained team members in best practices for data handling, improving overall productivity and data integrity.
Clinical Research Coordinator
Orlando Health - Formerly UF and MD Anderson Cancer Center Orlando
09.2013 - 08.2016
- Assist Principal Investigators during, IRB approved Inform Consent process with potential participants, ensuring all signatures, date and time are on the informed consent(s).
- Created source documents and worksheets to collect vital information from Principal Investigators, Sub-Investigators, Chemo Nurses, Pharmacy, Radiology and Laboratory personnel.
- Manage IWRS entries at visit time points and coordinate protocol required clinic visits and procedures via scheduling department for potential participants and enrolled participants.
- Followed up with participants after treatment(s), procedures and hospitalizations (SAE).
- Retrieved and collected data from hospital electronic medical records system, by reviewing, and abstracting information from progress notes, laboratory and radiology reports in a timely manner.
- Maintain research charts by performing internal chart audits.
- Reached out to monitor(s) and medical monitor(s) for clarifications, when required.
- Strong medical terminology with the ability to clarify and resolve manual and system generated queries daily and at critical time points.
- Ensure Adverse Event terminology is used, via Common Terminology Criteria for Adverse Events.
- Collected, completed, and submitted SAE and follow up reports with redacted PHI within 24hrs, to sponsor's safety department while ensuring Good Clinical Practice is enforced.
- Complete Revenue Compliance Worksheets for research budgeting department.
- Thoracic /Head and Neck Oncology
Clinical Data Manager II
07.2009 - 09.2013
- Responsible for the collection and timely entry of data for phase II and phase III clinical trials from internal and external source documents.
- Ensure Adverse Event terminologies correlate with Common Terminology Criteria for Adverse Events (CTCAEv4.0).
- Abstracted, completed, entered and submitted time sensitive paper case report forms and electronic case report forms to Cooperative/Government and Sponsor studies.
- Work independently and directly with CRA to resolve manual and system generated queries to ensure data is accurate and in compliance with the protocols.
- Assist in the development of case report forms for Principal Investigator Initiated studies.
- Create worksheets to capture specific information required for study and data entry.
- Perform internal chart audits in prep for monitoring visits and FDA inspections.
- Train new Data Managers on department processes, Standard Operating Procedures, Good Clinical Practice, protocol specifics, tool development, query resolution, AE terminology and how to maneuver database and comprehend (e)CRF completion guidelines.
- Hematology, Genitourinary, Head, Neck, and Thoracic Oncology
Education
Bachelor of Science - Health Sciences
SUNY Nassau Community College
Garden City, New York01.2006
Skills
- ICH Good Clinical Practice → Certificate
- Human Subject Research → Certificate
- Knowledge of Microsoft Platforms
- Complion – e-Regulatory
- Veeva Vault – Company’s SOP and Quality Event Reporting System
- Multiple eCRF database maneuverability and knowledge: Inform iMedidata Rave Oracle Life Science eClinical OS / IBM Clinical Development Advarra e-Source
- Excellent oral and written communication skills
- Outstanding organizational and meticulous abilities
- Strong professional interpersonal skills
- Leadership qualities
- Quality tools
- Quality control processes
- Documentation review
- Continuous improvement
- Internal auditing
- Training and coaching
- Staff management
- Document review
- Process implementation
- Corrective action planning
- Teamwork
- Teamwork and collaboration
- Problem-solving
- Time management
- Attention to detail
- Problem-solving abilities
- Excellent communication
- Reliability
- Documentation skills
- Quality inspection
Timeline
Quality Control Auditor
AES/PPD-Thermo Fisher Scientific
02.2019 - 07.2025
Data Manager
AES/PPD Thermo Fisher Scientific
08.2016 - 07.2025
Clinical Research Coordinator
Orlando Health - Formerly UF and MD Anderson Cancer Center Orlando
09.2013 - 08.2016
Clinical Data Manager II
07.2009 - 09.2013
Bachelor of Science - Health Sciences
SUNY Nassau Community College
Therapeutic Area - Critical & Healthy Adults
- Neurological, General Medicine, Pain, Vaccine and Phase 1 clinical trials- first in human use.
- Oncology: Genitourinary, Hematology, Melanoma/Sarcoma, Thoracic /Head and Neck Cancer clinical trials.
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