JUDE NWOKORO
Frisco,TX
Summary
Dedicated Senior Clinical Research Associate successful at evaluating sites, initiating trials and managing closeouts. Experienced with various therapeutic areas and successful at adapting to new processes. Bringing excellent organizational, planning and interpersonal skills gained during more than 10 years career.
Overview
10
10
years of professional experience
Work History
Senior Clinical Research Associate
IQVIA
04.2017 - Current
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
- Performs remote and onsite monitoring visits ensuring data is accurate, subjects rights and safety is protected, and clinical trials are in compliance with ICH/GCP regulations
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
- Provides regular site status information to team members, trial management, and updates trial management tools
- Completes monitoring activity documents as required by IQVIA’s SOPs or other contractual obligations
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
- Manages and maintains information and documentation in Clinical Trial Management Systems (CTMS), electronic Trial master File (eTMF) and all other available systems
- Performs essential document site file reconciliation
- Performs source document verification, source data review and query resolution
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per required pathways in collaboration with Direct Line Manager
- Assesses Investigational Product accountability, dispensation, and compliance at the investigative sites
- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
- Facilitates audits and audit resolution
- Acts as a mentor to junior level CRAs and serves as a resource for new employees including conducting co-monitoring visits
- Serves as resource for and interacts with other functional areas to resolve site issues and facilitate trial timeline.
Clinical Research Associate
QUINTILES
06.2014 - 04.2017
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
- Performs remote and onsite monitoring visits ensuring data is accurate, subjects rights and safety is protected, and clinical trials are in compliance with ICH/GCP regulations
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
- Provides regular site status information to team members, trial management, and updates trial management tools
- Completes monitoring activity documents as required by IQVIA’s SOPs or other contractual obligations
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
- Manages and maintains information and documentation in Clinical Trial Management Systems (CTMS), electronic Trial master File (eTMF) and all other available systems
- Performs essential document site file reconciliation
- Performs source document verification, source data review and query resolution
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per required pathways in collaboration with Direct Line Manager
- Assesses Investigational Product accountability, dispensation, and compliance at the investigative sites
- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
- Facilitates audits and audit resolution.
Education
Master of Business Administration -
University of the people
01.2021
Bachelor of Arts-Philosophy -
University of Ibadan
Skills
- Site Management
- Clinical Trial Management
- Investigational Product
- Informed Consent
- Site Initiation
- Regulatory Compliance
- EDC
- Query Resolution
- Routine Monitoring
- TMF
Technical Computer Experience
- Microsoft Office Suite: Excel, Word, Outlook, and Power Point
- IVRS: Signant, ClinPhone, Almac
- EDC: InForm, Rave
- CTMS: Oracle, Impact, Veeva (CTMS, eTMF)
Professional Training Certifications
- Barnett Accreditation Expert GCP Exam for Managers and staff interacting with investigational sites (2014 ,2015, and 2018)
- Fundamental GCP Accreditation Exam 4.0 (IQVIA training 2022)
Therapeutic Areas Experience
- Infectious disease: Influenza
- CNS: Alzheimer’s Multiple Sclerosis
- Ophthalmology: Age Related Macular Degeneration
- Ophthalmology: Diabetic Macular Edema
- Endocrinology: Diabetes Mellitus Type 2
- Nephrology: Chronic Kidney Disease
- Cardiovascular: Ischemic Stroke, Myocardial infarction. Hypertensive disorder
- Oncology: Prostate Cancer, Chronic Lymphocytic Leukemia
Timeline
Senior Clinical Research Associate
IQVIA
04.2017 - Current
Clinical Research Associate
QUINTILES
06.2014 - 04.2017
Master of Business Administration -
University of the people
Bachelor of Arts-Philosophy -
University of Ibadan