Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
Generic

Osita Frank Akuchie

Atlanta,GA

Summary

A seasoned Clinical Trials Monitor with a proven track record at Emory University, I excel in ensuring compliance with FDA and other regulatory requirements through meticulous monitoring and documentation. My expertise in Medidata Rave and exceptional communication skills have significantly contributed to the enhancement of clinical trial performance and compliance, achieving a notable improvement in study accuracy and efficiency.

Overview

13
13
years of professional experience

Work History

Clinical Trials Project Manager

Emory University
Atlanta, GA
09.2022 - 06.2024
  • Provided clinical trial monitoring to ensure compliance with regulations and established processes.
  • Tracked essential regulatory documents, reporting safety events in a timely manner.
  • Led start-up studies, ensuring adherence to regulatory requirements throughout.
  • Managed collation and distribution of study tools and documents, updating clinical trial databases.
  • Collaborated on clinical supply and non-clinical supply management across country roles.
  • Prepared Investigator Site Binders, Patient Folders, and Regulatory Folders for trial use.
  • Conducted monitoring activities to verify compliance with approved protocols and regulatory standards.
  • Maintained accurate records of correspondence and monitoring reports per operational procedures.

Clinical Research Systems Associate

NY Langone Health
New York City, NY
02.2022 - 09.2022
  • Troubleshot system issues and implemented enhancements to optimize functionality.
  • Collaborated with business leads to identify and prioritize needs for future upgrades.
  • Fulfilled essential business administration tasks to support operational efficiency.
  • Managed user access requests for Veeva, EDC, and CTMS, ensuring compliance and timely approval.
  • Led development and execution of end-user training programs for Veeva Vault Clinical and CTMS.
  • Coordinated documentation requests for audits and regulatory inspections with relevant stakeholders.
  • Partnered with IT and business teams to resolve system issues and establish improvement strategies.
  • Maintained accurate records of end-user compliance within company protocols.

Clinical Research Associate

Novo Nordisk
Princeton, NJ
02.2021 - 02.2022
  • Verified investigator qualifications and resources throughout trial duration to ensure safety and compliance.
  • Maintained electronic Trial Master Files (TMF) in accordance with standard operating procedures.
  • Conducted ongoing TMF reviews to ensure high-quality documentation and adherence to regulations.
  • Developed oversight strategies in collaboration with trial team members.
  • Oversaw CRO monitoring reports, training records, and performance against milestones.
  • Planned and executed oversight monitoring visits and attended CRA training activities with CRO.
  • Served as primary liaison for assigned study sites to communicate project updates and resolve inquiries.
  • Collaborated with study team on Corrective Action Plans (CAP) for investigative sites to enhance compliance.

Clinical Research Associate (Temporary)

Nestle Health Sciences
Bridgewater, NJ
08.2020 - 02.2021
  • Provided operational input on development and management of study plans and tools.tools.
  • Assisted in designing clinical research projects and corresponding project plans.
  • Managed progress of protocols, case report forms, and study manuals effectively.
  • Conducted comprehensive site visits including qualification, initiation, monitoring, and closeout.
  • Prepared and distributed case report forms, study reference manuals, and monitoring guidelines.
  • Executed periodic monitoring activities with investigative sites to review case report forms.
  • Identified and escalated issues prior to site activation to prevent critical delays.
  • Maintained strong relations with investigators and site staff throughout project lifecycle.

Clinical Research Associate (In-House)

BMS (Former Celgene)
Summit, NJ
02.2019 - 03.2020
  • Conducted site feasibility assessments and provided selection recommendations to trial team.
  • Led team meetings with site personnel to ensure alignment on study objectives.
  • Collaborated with CTM and trial team to prepare, review, and execute CDAs and CTAs.
  • Managed preparation, review, and follow-up of ICFs, tracking IRB submissions and amendments.
  • Developed CRF templates for site use to streamline data collection processes.
  • Executed study initiation activities, reviewing protocols and providing training on e-CRF completion.
  • Ensured comprehensive training records for site staff were maintained throughout trial phases.
  • Monitored clinical drug supplies for proper handling, storage, inventory, and documentation.

In-house CRA

Covance
Princeton, NJ
04.2015 - 08.2018
  • Implemented and monitored clinical trials to ensure compliance with local regulations and ICH-GCP guidelines.
  • Assessed qualifications of potential investigative sites and initiated trials at selected locations.
  • Instructed site personnel on proper conduct of clinical trials and managed trial closures.
  • Reviewed and verified accuracy of clinical trial data collected onsite and remotely.
  • Provided regular updates on site status to team members; maintained trial management tools.
  • Completed monitoring activity documentation according to SOPs and contractual obligations.
  • Collaborated with clinical team members to resolve trial issues promptly.
  • Escalated site-related issues per SOPs until resolution or closure.

Lead ETMF Specialist

Covance Inc.
Princeton, NJ
04.2015 - 09.2015
  • Managed setup and maintenance of electronic trial master files for clinical studies, ensuring compliance with TMF processes.
  • Coordinated approval and control of clinical trial documents to streamline operations.
  • Led development and maintenance of eTMF plan and TMF index alongside project manager and study lead.
  • Mapped sponsor's TMF index to Covance TMF index, updating and modifying approved artifacts as per SOPs.
  • Maintained TMF in audit-ready state through visual quality checks and comprehensive document assessments.
  • Executed audits on eTMF documents to confirm clarity, accuracy, and completeness for each study.
  • Compiled performance metrics for TMF reviews to enhance operational efficiency.
  • Prepared TMF artifacts for export to sponsors at key study milestones, collaborating with project stakeholders.

Clinical Research Coordinator

Temple University Hospital
Philadelphia, PA
01.2013 - 02.2015
  • Maintained multiple tracking spreadsheets for clinical trial progress, including essential documents and investigational products.
  • Constructed ISF folders while filing and updating study documents.
  • Ordered, prepared, packaged, and shipped materials to sister clinical trial sites as needed.
  • Provided support to imaging centers, laboratories, and other study vendors.
  • Reviewed all regulatory documents from sites for accuracy and compliance with company SOPs.
  • Tracked regulatory information for reference while maintaining required documentation.
  • Ensured timely updates of regulatory documents to meet compliance standards.
  • Assisted monitors with in-house duties for sites located outside of United States.

Data Entry Lead

Fairmount Behavioral Hospital
Philadelphia, PA
01.2011 - 11.2012
  • Maintained patient stability by monitoring vital signs, weight, and intake/output data.
  • Administered adjunct care, including enemas, dressings, and therapeutic baths.
  • Transported patients and addressed requests to enhance comfort and safety.
  • Ensured confidentiality of patient information to protect organizational integrity.
  • Complied with professional standards and regulations to uphold hospital policies.
  • Updated professional knowledge through educational opportunities and publications.
  • Developed standard operating procedures to streamline daily tasks and improve efficiency.
  • Reviewed processes to identify improvements in data entry accuracy and speed.

Education

Associate Nursing -

Community College of Philadelphia
Philadelphia, PA

Skills

  • Microsoft Office Word
  • Effective Time Management
  • Communication Skills
  • Ability to Work in a Team
  • Microsoft PowerPoint
  • Computer Skills
  • Microsoft Excel
  • Microsoft Office
  • Medidata Rave
  • RedCap
  • Electronic Trial Master File
  • InForm
  • Veeva Vault
  • ERT Clario
  • Preclarus
  • E-Site and Lablink
  • Endpoint
  • Data Governance
  • Celtrak
  • CelAlert
  • Ms Teams
  • Clinical Trial Management System
  • Ms Note
  • Ms Outlook
  • Ms Projects
  • EPIC
  • SharePoint
  • Medical device experience as a monitor
  • Case report management
  • Adverse event tracking
  • Study monitoring

Affiliations

  • Oncology. Medical Device. Cardiovascular disease. Infectious diseases. Dermatology. Immunology. Respiratory disease. Neuroscience. Endocrinology. Ophthalmology. CNS. Rare disease. Hematology. Neurology. Nephrology
    Pain management. Pediatrics. Psychiatry. Urology. Vaccination

Timeline

Clinical Trials Project Manager

Emory University
09.2022 - 06.2024

Clinical Research Systems Associate

NY Langone Health
02.2022 - 09.2022

Clinical Research Associate

Novo Nordisk
02.2021 - 02.2022

Clinical Research Associate (Temporary)

Nestle Health Sciences
08.2020 - 02.2021

Clinical Research Associate (In-House)

BMS (Former Celgene)
02.2019 - 03.2020

In-house CRA

Covance
04.2015 - 08.2018

Lead ETMF Specialist

Covance Inc.
04.2015 - 09.2015

Clinical Research Coordinator

Temple University Hospital
01.2013 - 02.2015

Data Entry Lead

Fairmount Behavioral Hospital
01.2011 - 11.2012

Associate Nursing -

Community College of Philadelphia

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Osita Frank Akuchie