Nikel Chevalier
Derwood,MD
Summary
As a dedicated medical professional with a bachelor’s degree in medicine and over three years of experience in clinical research trials, I specialize in research for the treatment of retinal diseases. My expertise spans conducting and managing clinical trials, data analysis, and patient care. With a strong commitment to advancing medical knowledge and improving patient outcomes, I bring a detail-oriented approach and a passion for innovation in the field of ophthalmology. I have experience with FDA-approved drugs Syfovre and Izervay for the treatment of GA secondary to AMD.
Overview
7
7
years of professional experience
Work History
Clinical Research Coordinator
The Retina Group of Washington
01.2022 - Current
- Assist with recruitment efforts and scenes potential patients for eligibility for studies
- Obtains informed consent from patients and conducts study visits for clinical trials, under the supervision of research staff (Regional Research Manager and Clinical Research Coordinators)
- Assist with creating Case Report Forms
- Assist with completing assessments on study subjects as per protocol
- Enters study data into EDC systems
- Collects, process, stores and ships lab specimens; documents lab procedures, ab results and follows up with patients and medical staff as necessary
- Assists with coordinating monitor's visit with CRAs for each trial to ensure accurate documentation; makes corrections to data as necessary
- Assists with submissions and reports to the IRB; maintains documentation of IRB communications and decisions
- Documents adverse events and notifies PI, sponsor and IRB, with guidance from research staff
- Assumes investigational product/ device accountability
- Possess knowledge and understanding of each protocol that has been assigned as a primary responsibility
- Maintains compliance with Good Clinical Practice; Clinical Safety Data Management, 21 CFR, and has IATA certification
- 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.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Clinical Research Coordinator/ Scribe
Clinical Research Coordinator
06.2020 - 07.2021
- Oversee clinical trials, collect, code, and analyze data
- Inform participants about study objectives and administer questionnaires
- Monitor participant adherence to study rules and regulatory standards
- Maintain detailed records as per FDA guidelines
- Manage study supplies and engage with subjects
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
General Physician
West Demerara Reginal Hospital
10.2017 - 04.2019
- Provided comprehensive physical examinations for patients to diagnose and treat illnesses
- Assessed patients' medical histories, ordered laboratory tests and prescribed medications as necessary
- Coordinated with other physicians to provide comprehensive patient care plans
- Explained test results and recommended next steps in the diagnostic process if needed
- Maintained accurate and thorough patient charts in accordance with legal and clinical standards.
Education
M.D. -
Shandong Medical University
Jinan, Shandong07.2017
Skills
- Specimen Collection / Processing
- Medication dispensing
- Research Experience
- Records Maintenance
- Documentation
- Management
- Trial oversight
- Research experience
- Dispensing oversight
- Case report management
- Specimen handling
- Data Analysis
- Quality SOPs Development
- Organizational Skills
Timeline
Clinical Research Coordinator
The Retina Group of Washington
01.2022 - Current
Clinical Research Coordinator/ Scribe
Clinical Research Coordinator
06.2020 - 07.2021
General Physician
West Demerara Reginal Hospital
10.2017 - 04.2019
M.D. -
Shandong Medical University
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