Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Nsude (Sue) Okeke

Cincinnati,OH

Summary

Motivated clinical research professional with 5 years of progressive experience in the clinical research space. Possess a track record of meeting project timelines, improving processes, cultivating change, and managing projects with detail and care. Extensive experience on operational aspects of conducting clinical studies including leading & working on collaborative clinical teams, managing study level activities to deliver high quality data as per ICH-GCP, SOPs, and protocol requirements. I am now looking to leverage my multifaceted skill sets in a long-term role as a clinical trial manager

Overview

9
9
years of professional experience
1
1
Certification

Work History

Clinical Research Associate II

Medpace
Cincinnati, OH
01.2021 - Current
  • Coordinating and scheduling protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Traveling to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Gathering and organizing clinical trial documentation to meet rigorous standards for site approval.
  • Providing guidance and leadership to co-monitors and junior CRAs
  • Reviewing clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.

Clinical Research Associate

Medpace
Cincinnati, OH
08.2020 - 01.2021
  • Travel to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Review data queries and listings and worked with study centers to resolve data discrepancies.
  • Coordinate and schedule protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Review clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Completed PACE CRA Training and put knowledge and skills learned into practice with multiple on-site training/co-visits for oncology, COVID-19, NASH studies
  • Completed institution monitoring certificates in ATMP/Gene Therapy, radiopharmaceuticals, infectious diseases, oncology, cardiology/metabolism, and rare diseases

Clinical Research Regulatory Coordinator II

Rush University Medical Center | Research Admin
Chicago, IL
06.2019 - 08.2020
  • Served as the research regulatory operations consultant on a Shared Services Team for various clinical research departments
  • Drafted protocols, ICFs, and IRB applications for various departments and independent research investigators (for both industry and internal projects.
  • Prepared and submitted various contractual agreements (such as CDAs, medical grant agreements, CRAs, MTA, NDAs, etc) between industry sponsors and investigators. Assists the Rush Legal team with statements of agreements.
  • Oversaw the regulatory start up process of $2 million worth of COVID-19 research projects
  • Conducted laboratory safety inspections with the Safety Officer from the Department of Occupational Safety and generated data, reports, and presentations in order to address lab compliance
  • Served as the primary regulatory contact between industry sponsors and Rush clinical research/ clinical trial studies. Participates in study teams to ensure implementation of amendments, awareness of safety, and protocol changes and document version control
  • Collaborates closely with the Office of Research Affair, the Research Compliance Office, and Office of Occupational Safety to ensure the ethical and safe conduct of research for the Office of Basic Biological Sciences and the Neurology department
  • Provide support and guidance to research teams lacking regulatory support
  • Assists in the development, implementation and maintenance of policies (e.g.: education policy , and electronic notebook policy)
  • Served as a scientist member of the Institution Review Board (IRB)

Lead Project Coordinator| Clinical Research Coord.

Shirley Ryan AbilityLab | Center For Bionic Med
Chicago, IL
12.2017 - 06.2019
  • Lead project coordinator for the hospital's largest-clinical trial project and a multi-site clinical research project
  • Identified optimal recruiting strategy for assigned clinical research study, which included extracting data from medical records and research subject databases.
  • Executed recruiting strategy to maximize study enrollment, participated in subject screening and recruitment, and guided subjects through the ICF process
  • Managed all data associated with assigned clinical research projects, including original source documents and data entered into electronic case report forms and interacted with study sponsors or contract research organizations to address all data inquiries; Created and maintained source documents in preparation of sponsor, CRO, FDA inspection
  • Supported all aspects of regulatory submissions including Institutional Review Board (IRB) processing and approval, ISF maintenance, and Clinicaltrials.gov listing and reporting
  • Delegated tasks to a technical team of engineers, data scientists, engineering interns and research clinicians (MDs, PTs and SLPs) order to meet project initiatives
  • Manage timelines, resources and responsible for the management/delegation of tasks for a cross-functional study team of multiple PI's, research clinicians, research engineers, and interns
  • Provided product and protocol training to new research team members
  • Worked with principal investigator and sponsors to facilitate daily trial activities and ensure compliance with research protocols
  • Prepared and presented intermittent project findings to research team and multiple investigators
  • Hosts sponsors or contract research organizations during study specific visits including but not limited to site qualification visits, site initiation visits, monitoring visits, and study closeout visits.
  • Assisted in drafting manuscripts for publication and scientific presentations when feasible.

Hospital Administrative Intern/Pharmacy Technician

Carle Foundation Hospital: Inpatient Pharmacy
Urbana, IL
05.2016 - 09.2017
  • Maintained proper drug storage procedures, registries, and records for controlled drugs.
  • Prepared intravenous solutions, admixtures, respiratory drugs and other solutions using aseptic techniques.
  • Located and measured medications according to prescription information, making modifications as instructed by pharmacists and providers.
  • Communicated with patients to collect information about prescriptions and medical conditions or arrange consultations with pharmacists.
  • Receive investigational drugs using established institutional guidelines and sponsor requirements.
  • Order and maintain protocol specific to inventory.
  • Work with IDS pharmacists to set up and operationalize new clinical trials
  • Monthly billing and payroll activities.
  • Maintain and manage sponsor established temperature storage guidelines.
  • Track monthly metrics of IDS workload activities.
  • Meet with sponsor representatives to ensure proper study maintenance and resolve issues that arise.
  • Compound and dispense protocol specific medications following institutional and sponsor specific procedures.
  • Process patient returned and expired study medication based on sponsor and institutional guidelines.
  • Create and update standardized operating procedures for technician roles.
  • Train new technicians and research pharmacy staff. working as Certified Pharmacy Technician,
  • Participated in hospital-operations administrative internship under direction of the Director of Hospital Physician Services.

Education

Master of Science - Health Communication

Northwestern University
Evanston, IL
08.2018

Bachelor of Science - B.S. Neuroscience, B.S. Health Administration

Central Michigan University
Mount Pleasant, MI
2016

Certificate Of Completetion - Pharmacy Technician

Waubonsee Community College
Sugar Grove, IL
2014

Skills

Therapeutic Areas: Neurology, Wearable Sensors, Metabolic/Endocrine Disease, Oncology, Immunology, Cardiology, Rare Disease, NASH, Radiopharmaceutical, Gene Therapy, Phases: I-III, Preclinical

Techinical Systems: Medidata, ePRO, IRT/IVRS, EDC/eCRFs, CTMS, EPIC, Cerner, Braintree, eTMF, MS-Office

Trial Management: Clinical Trial Management; Project Management; Interdisciplinary Team Supervision; study tools development; study start deliverables; vendor management; data management; study task delegation;study team training & supervision

Regulatory Affairs: SOP Development, ICH/GCP/ FDA/ EU Guidelines; Informed Consent Development; Regulatory Submissions; Contract/Budget Development and Dissemination

Clinical Monitoring: Trip Reports, Status Reporting, Site Management, Team Training; site qualification, initiation, interim monitoring; source data verification and source data review; IP and safety report reconciliation

Certification

1. Udemy- Project Management Certification

2. PRIM&R's Certification in the Foundations of Human Subjects Protections

3. NIH- Principles of Pharmacology

Timeline

Clinical Research Associate II

Medpace
01.2021 - Current

Clinical Research Associate

Medpace
08.2020 - 01.2021

Clinical Research Regulatory Coordinator II

Rush University Medical Center | Research Admin
06.2019 - 08.2020

Lead Project Coordinator| Clinical Research Coord.

Shirley Ryan AbilityLab | Center For Bionic Med
12.2017 - 06.2019

Hospital Administrative Intern/Pharmacy Technician

Carle Foundation Hospital: Inpatient Pharmacy
05.2016 - 09.2017

Master of Science - Health Communication

Northwestern University

Bachelor of Science - B.S. Neuroscience, B.S. Health Administration

Central Michigan University

Certificate Of Completetion - Pharmacy Technician

Waubonsee Community College

Similar Profiles

CREATE PROFILE