Summary
Overview
Work History
Education
Skills
THERAPEUTIC AREAS:
Timeline
Generic

Bukky Awodein

Houston,Texas

Summary

Experienced field CRA with 8 years in Phase I, II, III, and Senior Clinical Trials Associate roles. Skilled Clinical Research Coordinator with 2 years of national travel experience. Proficient in GCPs, ICH Guidelines, and FDA Regulations, excelling in PSSVs, SIVs, IMVs, and COVs. Known for delivering results under pressure with a proactive work ethic and strong interpersonal skills. Extensive knowledge of medical terminology and clinical monitoring processes. Advanced expertise in Oncology, Neurology, Respiratory, Infectious Disease, and Cardiovascular Disease.

Overview

11
11
years of professional experience

Work History

Senior Clinical Research Associate I

PPD
04.2019 - Current
  • Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
  • Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
  • Assesses site processes
  • Conducts Source Document Review of appropriate site source documents and medical records
  • Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
  • Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
  • Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
  • Verifies site compliance with electronic data capture requirements
  • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
  • Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
  • May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
  • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
  • May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.

Clinical Research Associate I-III

PPD
07.2016 - 04.2019
  • Performs Selection, Initiation, Monitoring, and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and POI SOPs for monitoring requirements.
  • Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
  • Tracks and supervises collection of ongoing study data for purpose of regular project status reporting.
  • Collects and reviews regulatory documents as required.
  • Prepares site visit reports and telephone contact reports.
  • May participate in the start-up process including reviewing protocols, reviewing CRFs, preparing Informed Consent forms, developing study documents, and organizing and presenting at investigator meetings.
  • Resolves site issues, including site recruitment challenges, and determines status for IP shipment.
  • Assists the Project Manager (PM), Clinical Team Leader and/or Lead CRA (CTL/LCRA) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission.
  • Works with PM/CTL/LCRA to secure authorization of site contracts.
  • Informs team members of completion of regulatory and contractual documents for individual sites.
  • Attends Investigator Meetings (IM) and study specific training meetings.
  • May translate, coordinate translations or review completed translations of critical documents.
  • Participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation. Follows the feasibility procedures for documentation of feasibilities performed.
  • Identifies the documentation required for review by Regulatory Authorities and Ethical Committees. Prepare Regulatory and Ethics Committee submissions. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation.
  • Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required.
  • Conducts Assessment and/or Training Visits of CRA I/II as required.
  • Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings.
  • Organizes processes for interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with POI accountant, logging trial expenditure, receipts, invoices and income.

Clinical Research Coordinator

Baylor College of Medicine
04.2014 - 06.2016
  • Managed study finances including sponsor invoicing & resolving study subject billing issues
  • Developed advertising materials
  • Acted as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
  • Documented investigational product (drug/device) accountability
  • Self monitored and self-audit responsibilities
  • Developed informed consent document
  • Maintained Clinical Trials for given SOPs
  • Developed Case Report Forms
  • Was assigned more complex studies
  • Documented all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.
  • Maintained organized, accurate and complete study records
  • Assisted Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
  • Entered data as appropriate for protocol (paper-electronic data capture)
  • In conjunction with Principal Investigator, accurately reported and tracked adverse events as defined by each study protocol.
  • Performed study close-out procedures
  • Stored study records appropriately

Education

Bachelors - Biology

University of Maryland Global Campus
Hyattsville, MD

Skills

  • Inform
  • Medidata Rave
  • Omnicomm
  • Impact Harmony
  • Trial Master
  • Impact
  • E-clinical
  • Siebel
  • EDOCS
  • OCRDC

THERAPEUTIC AREAS:

  • Oncology: Breast Cancer – Phase I (3 years)
  • Lung – Phase II (1 year)
  • Bladder – Phase I(1 year)
  • Cervical – Phase II (1.5 years)
  • Head and Neck – Phase I (6-8 months)
  • Acute Leukemia – Phase I (2 years)
  • Breast Cancer - Phase I (2 years)
  • Colorectal Cancer - Phase II (1 year)
  • Gastric Cancer - Phase III (1 year)
  • Hodgkin’s Lymphoma - Phase I (1.5 years)
  • Non-Small Cell Lung - Phase I (1 year)
  • Central Nervous System:
  • Alzheimer’s Disease- Phase II (3 years)
  • Bipolar Disorder – Phase II (2 years)
  • Schizophrenia- Phase II (2 years)
  • Ophthalmology:
  • Glaucoma- Phase III (2 years)
  • Infectious Disease:
  • HIV/AIDS and FLU- Phase I (3years)
  • Cardiovascular:
  • Cardiac Arrest- Phase III (3 years)
  • Respiratory
  • Asthma - Phase I (2 years)
  • COPD - Phase I (2 years)
  • Cardiovascular: Hypertension - Phase III (1 year)
  • Oncology: Breast Cancer - Phase I (2 years)
  • Central Nervous System: Alzheimer’s Disease - Phase II (1 year)

Timeline

Senior Clinical Research Associate I

PPD
04.2019 - Current

Clinical Research Associate I-III

PPD
07.2016 - 04.2019

Clinical Research Coordinator

Baylor College of Medicine
04.2014 - 06.2016

Bachelors - Biology

University of Maryland Global Campus

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