Sunday Nnadozie
Lewisville,Texas
Summary
Accomplished Clinical Research Specialist with extensive experience leading and supporting one or several Class medical device trials (IDE/HDE/PMA/PAS) while fostering strong, collaborative, productive relationships cross-functionally across the organization. Demonstrated experience with Medical Device Reporting (MDR) MDR (EU) 2017/745 regulation (21 CFR Part 803), QMS application proficient. Proven experience serving as Protocol Execution Lead for early development/initiation of studies and regulatory documentation. Working knowledge of Quality System Regulations (QSR21
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate
Sarah Cannon, Remote
10.2018 - 07.2023
- Was responsible for leading and supporting one or several Class medical device trials (IDE/HDE/PMA/PAS) while fostering strong, collaborative, productive relationships cross-functionally across the organization
- Involved in Medical Device Reporting (MDR) MDR (EU) 2017/745 regulation (21 CFR Part 803), QMS application proficient
- Served as Protocol Execution Lead for early development/initiation of studies and regulatory documentation
- Working knowledge of Quality System Regulations (QSR21 CFR820), Canadian Medical Device Regulation (CMDR), EU Medical device Directive (EUMDD 93/42 EEC), and ISO 13485:2003 and 14155:2011
- Was responsible for monitoring all stages of the conduct of clinical trials in assigned study site, this Includes performing study Site Selection Visit, Site Initiation Visit, Routine Monitoring Visit and Close-out Visits according to company SOPs
- Ensured that all trip reports are completed to quality standards within company specified timelines
- Maintained required documentation in the investigator site file and provide required documentation for the Trial Master File
- Ensured that the assigned trial site complies with the study protocol, GCP, and applicable regulatory requirement for performing study activities regarding the implementation and monitoring of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations, and SOPs
- Managed investigational product supplies to trial site
- Kept track of drug lots/batches and expiration dates and assist in investigational product forecasting in accordance with study agreements
- Performed on-site drug accountability and reconciliation and verifies drug storage meets protocol and SOP requirements
- Verified patient eligibility, communicate, and document protocol violations, non- compliance, and poor performance and assure that corrective action is taken
- Performed ongoing reviews of Investigator’s Trial File to assure quality of the documentation files, completion, and compliance with company SOPs, GCP and ICH Guidelines while on site
- Completed follow up letters for all visit types according to SOPs and completes reports to quality standards within company specified timelines
- Liaised with other CRAs to ensure the harmony of standards and procedures
- Acted as primary liaison for assigned study sites while on-site to convey project information, answer questions and address study issues in accordance with the monitoring plan.
Opthalmic Patient Care Cordinator
John G McHenry
05.2022 - 12.2022
- Performed a range of duties which included preparing the patient to see Attending Physician (preliminary exam, medical history, & testing), preparation of examination and treatment rooms, performing basic and routine vision screening examinations, administering eye medications, cleaning and maintaining ophthalmic instruments and assisting physicians during minor surgical and laser procedures
- Provided primary ophthalmic care to patients and acts as clinical assistant to physicians
- Performed complete ophthalmic history and preliminary exams, sub-specialty tests (refraction, VF test, A-Scan Biometry (IOL master), Pachymetry, PAM evaluation, color testing, and contact lens evaluation)
- Verified patient information by interviewing patients, recording medical history, and confirming purpose of visit
- Accurately records all information in the EMR system according to established standards and physician requirements
- Checked the condition of patients' eyes by observing pupils, muscle, visual acuity, extraocular movements, and blood pressure (if requested by Physician)
- Prepared patients for ophthalmology examination by dilating pupils, changes in visual acuity, elevated intraocular pressure, or blood pressure and communicating results to Attending Physician
- Secured patient information and maintains patient confidence by completing and safeguarding medical records, completing diagnostic and procedure coding, and keeping patient information confidential
- Counselled patients by transmitting physician's orders, use of drops, contact lenses, drugs, and answer questions about surgery and specialty imagining required/ordered
- Maintained safe, secure, and healthy work environment by establishing and following standards and procedures along with complying with legal regulations
- Kept equipment operating by following operating instructions, troubleshooting breakdowns, maintaining supplies, performing preventive maintenance, and promptly reporting equipment issues.
Clinical Research Associate II
Sarah Cannon
06.2016 - 10.2018
- Ensured adherence to study protocols, company’s SOPs, and compliance with GCP guidelines and FDA regulations and IRB requirements
- Reviewed source documentation, case report forms, and data reports for accuracy, completeness, and timely submission
- Managed investigational product accountability
- Communicated and worked with site investigators and research staff to ensure proper reporting of adverse events and protocol deviations and escalated critical compliance issues to manager promptly
- Responded to any protocol-related issues and timely escalated to management
- Collected and transferred required site documents
- Arranged secure storage of study documents that was maintained according to Good Clinical Practice guidelines or for the contracted length of time
- Protected the rights and welfare of all human research participants involved in research in accordance with Federal regulations
- Reviewed on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identified deficiencies and discrepancies and provided remedial training and corrective action as required
- Developed and implemented study specific tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution.
Clinical Research Associate I
RHO
05.2014 - 06.2016
- Followed the corresponding Monitoring Guidelines for each assigned trial
- Coordinated and assisted with the activities associated with site start-up and overall study site management, including review of site documents in anticipation of site activation and site oversight through close-out
- Assisted with the preparation, conduct and presentations for CRA Trainings
- Assisted with coordination and management of study site budgets when assigned to
- Ensured that the study staff complies with the serious adverse event reporting requirements
- Prepared and submitted visit trip reports, Confirmation and Follow up letters within timelines outlined in the Clinical Monitoring Plan
- Ensured clinical site training records were current and maintained as required
- Assisted in the preparation and follow up of on-site sponsored quality audits, as well as regulatory authority inspections
- Identified data discrepancies, trends, and other analytics related to site performance
- Attended staff meetings and trainings as required
- Adhered to Clinical Operations or project specific quality documents (i.e
- SOPs, Work Instruction, etc.) as applicable
- Assisted with program oversight, identified deficiencies and risks, as well as improvement and mitigation plans
- Gained an in-depth understanding of the study protocol and related procedures.
Clinical Research Coordinator
Cedars-Sinai
02.2012 - 05.2014
- Maintained investigational drug/device dispensing accountability and shipping logs according to protocol guidelines
- Collected supplies and ensured everything was accounted for such as lab kits, ancillary supplies, and investigational medication
- Participated in web conferences and teleconferences for each study protocol in order to stay updated
- Instructed Principal Investigator on procedures and tests that needed to be performed in compliance with the study protocol and advised Principal Investigator on the results of procedures and tests, calling to attention findings of clinical importance
- Documented research related examinations, procedures, tests, and other activities in appropriate clinic or hospital charts
- Scheduled follow-up visits for study patients in collaboration with Principal Investigator and provided source documentation for the activities conducted during these visits
- Completed accurate and complete data entry into case report forms or pre-established computer programmed formats ensuring appropriate source documentation
- Scheduled and underwent initiated monitor visits and quality assurance audits for periodic reviewing and querying of collected data in a timely fashion.
Education
Doctor of Medicine -
Lugansk State Medical University
2012
Skills
- 2011
- Highly skilled with ensuring that the assigned trial site complies with the study protocol, GCP, and applicable regulatory requirement for performing study activities regarding the implementation and monitoring of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations, and SOPs
- Hands on experience performing ongoing reviews of Investigator’s Trial File to assure quality of the documentation files, completion, and compliance with company SOPs, GCP and ICH Guidelines while on site
- Therapeutic Experience:
- Medical Devices: Ascites abdominal pump, Catheter, Bypass Grafts, IVD, Colonoscopy, Inhaler
- Circulatory: Hypertension, ACS, Stroke, and Cardiomyopathy
- Neurology: Alzheimer’s disease, Parkinson’s disease, Neuropathic Pain, Multiple Sclerosis
- Ophthalmology: Glaucoma, Macular Degeneration
- Oncology: Ovarian Cancer, Colorectal Cancer, Leukemia, Melanoma, Breast Cancer
- Rare Diseases: Kawasaki Disease, Crohn’s Disease, Systemic Lupus
- Infectious Diseases: COVID-19 (Vaccine)
Certification
CFR820), Canadian Medical Device Regulation (CMDR), EU Medical device Directive (EUMDD 93/42 EEC), and ISO 13485:2003 and 14155
Timeline
Opthalmic Patient Care Cordinator
John G McHenry
05.2022 - 12.2022
Senior Clinical Research Associate
Sarah Cannon, Remote
10.2018 - 07.2023
Clinical Research Associate II
Sarah Cannon
06.2016 - 10.2018
Clinical Research Associate I
RHO
05.2014 - 06.2016
Clinical Research Coordinator
Cedars-Sinai
02.2012 - 05.2014
Doctor of Medicine -
Lugansk State Medical University
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