CYPRIAN NWOKORO
Irvington,NJ
Summary
Result-oriented scientist with background in development, clinical research, various healthcare settings, well-versed in both cosmetic, pharmaceutical and biopharmaceutical industry. Knowledgeable about action planing, GCP, GMP, ICH, database lock and standard operating system
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Project Associate
Gilead Sciences, Inc.
Morris Plains, NJ
04.2021 - Current
- Review the SAE listing for unreported cases not following the SOP.
- Reconcile docs. across the EDC, eTMF, Gilead System and Vendors trackers.
- Manage the reviews and update the revised newsletter
- Serve as CRA backup providing verbal and written communication with study personnel, while reviewing monitoring reports after filing in the TMF.
- Manage, draft and finalize meeting agenda and assists in preparing meeting minutes.
- manage the FDA navigation report in the preparation of audits and inspection readiness.
- Grant access to study EDC for internal company employee for the study and vendors
- Process of drug shipments, drug returns and assist with in house drug reconciliation.
- Point of contact for updating all Gilead systems for the Trodelvy study.
Intern/Clinical Research Associate/Quality Control
DSCS Sweat Equity & Investments, LLC dba DSCS CRO
08.2020 - 04.2021
- Managing the ongoing source data review and regulatory for a Phase 1 oncology study
- Assist with remote site monitoring visits to conduct source data review, informed consent, action item generation and resolution, IMV report drafting, follow up letters, and other related tasks
- Ensure that regulatory documents are complete and in compliance with federal, state, local, IRB, Sponsor, CRO and Site guidelines
- Ensure Investigator and site adherence to timelines and key performance metrics
- Collaborate with Senior DSCS CRAs on drafting monitoring reports,follow up letters,and action items
- Assist with IMVs and eTMF document collection for Senior DSCS CRAs
Product Development Technologist
Nuworld Beauty
Cataract, NJ
01.2018 - 05.2020
- Introduce and enhance the development of new and existing beauty products in the market
- Use of GMP with the Quality by Design principles to create and achieve product quality objectives and met USP specification
- Compile data on reported defective products and research, including improvements recommendations
Regulatory and Clinical Compliance Administrator
General Hospital, Kwara
11.2015 - 12.2017
- Tasks
- Acilitated and track the collection of preparation of documentation ready for submission for obtaining R&D approvals, research ethic committee approvals and other approvals needed to initial any study
- Performed the submission of protocol amendments, revised information sheets and other study documentation to the
- Egulatory authorities in the hospital for Nafdac
- Develop meetings minutes, agendas and track follow-up actions with patients for any adverse effect.
Intern Formulation and Procedure Operative Scientist
Alliance Boots
Nottingham, , UK
05.2012 - 09.2012
- Ensure product lines are working adequately, and the manufactured products meet the Quality standards of the MHRA, and
- British Pharmacopeia during testing
- Team work in setting up the product lines prior to formulation
- Involve in calibration and formulation of weighed excipients in bulk quantity.
Education
Health Care Leadership, Transforming HealthCare Delivery,From HealthDisparitiestoHealthEquity, Translating Ideas into Outcomes. -
Professional Development Certificate: Healthcare - undefined
Innovation
University of Pennsylvania
11.2021
Master of Science - Drug Discovery
University of Sunderland
01.2015
Bachelor of Science (Honors) - Pharmaceutical and Cosmetic Sciences
De Montfort University
07.2013
Skills
- Gathering requirements
- Risk management skills
- Organization skills
- Project planning
- EDC
- Monitoring Report
- SAE
- SOPs
- teamwork
- eTMF
- Source Data Review
- Newsletter
- Oncology
- Quality Control
- IMV
- GCP
- Action Items
- Quality and Compliance
Accomplishments
- Longdom Conference (Webinar Medical and pharmaceutical Science) Oct 05, 2020) (Speaker clinical Trials and its Opportunity in Pharmaceutical science), London UK.
- American Heart Association – Basic Life Support(BLS) June 2020, New Jersey USA.
- The Healthy Hair Expo by BlackSilk Sept, 2017. Health and Wealth Conference, Los Angeles Convention Centre, USA.
- Making Cosmetic Personal Care (Ingredient, Form & Manufacture) April 2015 Society of Cosmetic Scientist, Rico Arena Coventry, UK
- Manufacturing Health and Safety Programme, August2014 University of Sunderland, Sunderland UK.
- Drug Metabolism Conference July 2014 (Poster presenter How Quality by Design Affect Drug metabolism), Gordon Research Conference, Boston USA.
- Product for Paediatrics: It's Not Child's play Nov 2017. American Association of Pharmaceutical Scientist. Annual Meeting, San Diego, USA
- Healthy Canada Conference June 2017 Sheraton Centre, Toronto, Canada
- Continuous Manufacturing of Oral Solid Drug Product March 2015 American Association of Pharmaceutical Scientist 50th Arden Conference, Renaissance Harbour place Hotel, Baltimore USA
Certification
NIH:ICH-GCP (E6R2) (10/2020)
The CRA Academy (8/2020)
IATA-Dangerious goods training (8/2019)
Clinical Trial Highlights
Phase 3 Study of Sacituzumab Govitecan versus treatment of Physician's Choice in subjects with HR+ HER2- Mestastatic Breast Cancer (MBC).
A Phase 1 Dose-Escalation Study of XXX with XXX and XXX in the Neoadjuvant Setting in Previously Untreated Patients with ER+/HER2- Breast Cancer
Timeline
Clinical Project Associate
Gilead Sciences, Inc.
04.2021 - Current
Intern/Clinical Research Associate/Quality Control
DSCS Sweat Equity & Investments, LLC dba DSCS CRO
08.2020 - 04.2021
Product Development Technologist
Nuworld Beauty
01.2018 - 05.2020
Regulatory and Clinical Compliance Administrator
General Hospital, Kwara
11.2015 - 12.2017
Intern Formulation and Procedure Operative Scientist
Alliance Boots
05.2012 - 09.2012
Health Care Leadership, Transforming HealthCare Delivery,From HealthDisparitiestoHealthEquity, Translating Ideas into Outcomes. -
Professional Development Certificate: Healthcare - undefined
Innovation
University of Pennsylvania
Master of Science - Drug Discovery
University of Sunderland
Bachelor of Science (Honors) - Pharmaceutical and Cosmetic Sciences
De Montfort University
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