Lillian C Burgess
Lexington,SC
Summary
Accomplished Clinical Research Coordinator with a proven track record at Palmetto Retina Center, enhancing patient safety and ensuring trial accuracy. Expert in Good Clinical Practices and adept in adaptability, I significantly contributed to successful audits and study completions. Skilled in documentation management and fostering team collaboration, I drive results through meticulous attention to detail and regulatory compliance.
Overview
3
3
years of professional experience
Work History
Clinical Research Coordinator
Palmetto Retina Center
10.2023 - Current
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Complied with research protocols by providing ongoing quality control audits.
- Coordinated with multiple departments to ensure compliance with regulatory standards, leading to successful trial audits.
Clinical Assistant
Atrium Healthcare
03.2022 - 10.2023
- Participated in site monitoring visits, addressing any concerns or discrepancies related to patient enrollment or data collection procedures.
- Monitored safety events during clinical trials by promptly reporting adverse events and implementing corrective action plans as needed.
- Enhanced patient recruitment by developing targeted outreach strategies and materials for clinical trials.
- Managed updates and input for patient information database.
- Managed study databases, ensuring accurate data entry, storage, and retrieval for analysis purposes.
- Gathered, processed, and shipped lab specimens.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Prepared and collected lab specimens for diagnostic. evaluation.
- Explained procedures to patients to reduce anxieties and increase patient cooperation.
- Oriented and trained new staff on proper procedures and policies.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Manufacturing Associate -Cell Therapy
Dendreon Pharmaceuticals
12.2021 - 03.2023
- Works with other Cell Therapy Specialists utilizing current good manufacturing practices (cGMPs) to aseptically manufacture commercial products using Standard Operating Procedures (SOPs).
- Ensures right-the-first-time performance of all process steps specific to the phase or stage of operation. Escalates processing and equipment issues as needed.
- Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.
- Rigorously adheres to SOPs and cGMP regulations to accurately complete paper and electronic records associated with commercial manufacturing.
- Reviews in-process cGMP documentation for completeness and accuracy.
- Unpacks and checks materials received against specifications, maintains records of materials used and rejects unsatisfactory items when necessary.
- Prepares products for final shipment and maintains records of products shipped.
- Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.
- Helps drive the safety-first culture
- Applies job skills and company policies and procedures to complete a narrow range of tasks.
- Works on assignments that are simple in nature, escalates issues when required, and making routine recommendations.
- Normally receives general instructions on routine work, detailed instructions on non-routine and new assignments.
- Ability to be flexible and support all functions by readily responding to changing circumstances (i.e. shift changes) and business needs.
- Other duties as assigned
Education
Associate of Applied Science - Respiratory Therapy
American College For Medical Professionals
Orlando, FL08.2016
Diploma - Medical Assisting
Ultrasound Diagnostic
Atlanta, GA02.1998
Skills
- Good Clinical Practices
- Electronic Data Capture
- Documentation Management
- Study protocols
- Investigational product management
- Phlebotomy
- Specimen collections
- Specimen handling
- Medication Dispensing
- Quality Assurance
- Adaptability and Flexibility
- Informed Consent Process
Timeline
Clinical Research Coordinator
Palmetto Retina Center
10.2023 - Current
Clinical Assistant
Atrium Healthcare
03.2022 - 10.2023
Manufacturing Associate -Cell Therapy
Dendreon Pharmaceuticals
12.2021 - 03.2023
Associate of Applied Science - Respiratory Therapy
American College For Medical Professionals
Diploma - Medical Assisting
Ultrasound Diagnostic
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