Summary
Overview
Work History
Skills
Therapeutic Areas
Systems
Bachelors Degree
Timeline
Generic

WENDIE OLAGOKE

Houston,TX

Summary

Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.

Overview

14
14
years of professional experience

Work History

Senior Clinical Research Associate

Alpha Tau
05.2020 - 02.2024
  • Assists in project planning; timeline preparation, preparation and review of study plans, including the Clinical Monitoring Plan and review of eCRF guidelines/specifications
  • Provides vendor management that may include EDC, IRT, Central Lab, and specialty lab vendors
  • Independently manages the study start up activities for multi-center, US and/or global based studies
  • Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites' and CRA's overall performance
  • Provides monitoring oversight by reviewing monitoring schedules, metrics and reports
  • Responsible for the clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations statutes and SOPs
  • Performs routine data listings review
  • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
  • Assists with the development of protocol writing, informed consent development, CRFs, monitoring conventions, tracking forms, and other study related documents
  • Assists in managing and/or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

Clinical Research Associate II

Alpha Tau
07.2015 - 05.2020
  • Scheduled and conducted routine monitoring visits as per Clinical Monitoring Plans
  • Assisted in Identifying, enlisting and choosing sites
  • Assisted in coordinating site management activities
  • Reviewed and verified source documentation and electronic case report forms
  • Tracked data entry and enrollment timelines
  • Recorded and shared interactions with client and acted as their representative
  • Participated in meetings with investigative sites, key opinion leaders and consultants as needed
  • Responded promptly and appropriately to study questions and issues raised by investigative sites
  • Gathered and examined trial documents
  • Coordinated with Clinical Trial Manager and research sites to ensure timely progress of clinical trials
  • Created and implemented study-specific clinical monitoring tools and documents
  • Provided Clinical Sites with protocol-specific training and conducted regular monitoring visits with them
  • Planned and scheduled site visits
  • Created monitoring reports and document findings from site visits to confirm appropriate conclusions and actions taken.

Clinical Research Associate I

IQVIA
05.2012 - 07.2015
  • Identified and assessed the suitability of clinical study centers for participation in clinical trials
  • Trained clinical centers on the clinical study protocol, data collection and good clinical practices
  • Performed remote and on-site monitoring visits at participating clinical study centers to ensure the safety of study patients, the reporting of accurate study data and appropriate study management at the clinical study center
  • Documented site visits by preparing visit reports and follow-up letters to the clinical study centers
  • Assisted clinical centers with the preparation of IRB/EC submissions
  • Collected and archived study related documentation and correspondence
  • Communicated monitoring and site management updates to the internal clinical team
  • Assisted with the development of the clinical study Monitoring Plan
  • Developed training materials and other study-related documentation
  • Maintained clinical monitoring tracking tools for each clinical study.

Clinical Research Coordinator

Headlands Research Inc
06.2010 - 05.2012
  • Enrolled and followed adult oncology patients participating in clinical studies
  • Assigned studies and study-related duties to coordinators based on specialty and workload
  • Ensured that each study has a trained back-up coordinator
  • Prioritized projects and assignments
  • Assisted staff with balancing workload
  • Monitored staff development
  • Ensured required training is up to date
  • Shared information regarding training opportunities
  • Monitored unit budget to meet financial objectives for spend rate and funding.

Skills

  • Site Management
  • Report Writing
  • Coordinating site operations
  • Action planning
  • Coordinating supplies
  • Completing regulatory documents
  • Therapeutic Area Expertise
  • Study documentation mastery
  • Medical terminology fluency
  • Organizational capabilities
  • Quality Assurance Techniques
  • Investigator relations
  • Data Management Proficiency
  • Electronic Data Capture Systems
  • Informed Consent Process
  • Site monitoring expertise
  • Adverse event reporting
  • Regulatory Compliance Knowledge
  • ICH-GCP guidelines
  • Team Leadership Qualities
  • Study protocols
  • Research SOPs understanding

Therapeutic Areas

  • Oncology: Acute Myeloid Leukemia, CAR-T Cell Lymphoma, Colon Cancer, Solid Tumor, Breast Cancer and Non Small Cell Lung Cancer
  • Neurology: Parkinson Disease, Multiple Sclerosis, Dementia, Major Depressive Disorder and Adolescent Autism
  • Infectious Disease: Influenza, LMP1 CART-T, HIV and AIDS
  • Ophthalmology: Macular Degeneration, Dry Eye and Glaucoma
  • Cardiovascular Disease: Hypertension, Stroke and Congestive heart failure
  • Medical Device: Pain control, Pacemaker of the heart, VAD (gastrointestinal bleeding) and congestive heart failure.

Systems

EDC: Medidata Rave,Medidata RaveX Inform, Trailmaster, Medrio and Oracle RDC

ETMF: Veeva Vault, Wingspan, SureClincal and  Pharm/CARSeTMF safe.

CTMS: Veeva Vault, Icotrail, Oracle, Rave CTMS and sponsor related systems 

IWRS: Suvoda and Endpoint.


Bachelors Degree

  • Biology

Timeline

Senior Clinical Research Associate

Alpha Tau
05.2020 - 02.2024

Clinical Research Associate II

Alpha Tau
07.2015 - 05.2020

Clinical Research Associate I

IQVIA
05.2012 - 07.2015

Clinical Research Coordinator

Headlands Research Inc
06.2010 - 05.2012

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WENDIE OLAGOKE