Osita Frank Akuchie
Atlanta
Summary
Dynamic Clinical Research Coordinator with extensive experience at Emory University, excelling in regulatory compliance and patient recruitment. Proven ability to manage electronic trial master files and enhance operational efficiency. Strong communication skills and adept at fostering collaboration among diverse teams to drive successful clinical outcomes.
Overview
15
15
years of professional experience
Work History
Clinical Research Coordinator
Midatlantic Retina
Philadelphia
08.2025 - Current
- Managed patient recruitment and informed consent processes for clinical studies.
- Oversaw regulatory submissions, ensuring compliance with institutional review boards.
- Collaborated with physicians to develop study protocols and ensure adherence.
- Maintained accurate study records and managed data within electronic systems.
- Facilitated communication among patients, investigators, and sponsors throughout trials.
- Scheduled and conducted monitoring visits for ongoing clinical research projects.
- Monitored patient safety during trials according to established guidelines.
- Reviewed case report forms for completeness before database entry.
Clinical Research Coordinator III
Emory University
Atlanta
09.2022 - 06.2024
- Tracked regulatory documents and reported safety events promptly.
- Ensured adherence to regulatory requirements during start-up studies.
- Managed collation and distribution of study tools, updating clinical trial databases.
- Collaborated on clinical and non-clinical supply management across country roles.
- Prepared Investigational Site Binders, Patient Folders, and Regulatory Folders for trials.
- Conducted monitoring activities to verify compliance with protocols and regulations.
- Maintained accurate records of correspondence and monitoring reports according to procedures.
- Participated in developing and executing the eTMF Management Plan.
Clinical Research Systems Associate
NY Langone Health
New York City
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
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
08.2020 - 02.2021
- Provided operational input on development and management of study plans and 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
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
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
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
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
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, PAPhiladelphia, 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
- 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
- Patient recruitment
- Regulatory compliance
- Data management
Therapeutic Areas Experience
- 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 Research Coordinator
Midatlantic Retina
08.2025 - Current
Clinical Research Coordinator III
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
Similar Profiles
JOLANTA GRATKOWSKAJOLANTA GRATKOWSKA
NA at MidAtlantic RetinaNA at MidAtlantic Retina
Theresa StrussTheresa Struss
Chiropractic Assistant at MidAtlantic Chiropractic CenterChiropractic Assistant at MidAtlantic Chiropractic Center
Jamie MinnichJamie Minnich
INSURANCE VERIFICATION SPECIALIST at TRINITY HEALTH MIDATLANTIC/ ST MARY MEDICAL CENTERINSURANCE VERIFICATION SPECIALIST at TRINITY HEALTH MIDATLANTIC/ ST MARY MEDICAL CENTER
Ke'Antra SmothersKe'Antra Smothers
Security Officer at Allied UniversalSecurity Officer at Allied Universal
Shamarra WoodsShamarra Woods
Logistics Specialist at Pratt IndustriesLogistics Specialist at Pratt Industries