Clinical Research Associate

Clinical Research Associate profile

Accomplished Clinical Research Associate (CRA) with over 8yrs in clinical research and 3yrs as a clinical monitor. Medical degree holder with expert knowledge of ICH-GCP, GPP, and regulatory guidelines. Proven track record in site qualification, initiation, monitoring, and close-out, with a keen focus on patient safety, data integrity, and protocol adherence. Excellent communicator and presenter, with ability to manage and swiftly adapt to evolving project demands. Willing to learn and embrace new technologies

CORE COMPETENCIES

Regulatory Compliance: ICH/Good Clinical Practice, GPP, IRB submissions, FDA regulations

Clinical Monitoring: Site Qualification, Initiation, Monitoring and Close-Out visits, Source document verification, Developing and implementing SOPs

Data Management: Chart abstraction & data collection, Case Report Form Review, Query Resolution

Patient Safety: Informed Consent process, AE/SAE reporting, Pharmacovigilance, Patient advocacy

Computer Skills: Clinical Trial Management Systems, Electronic Data Capture, Electronic Medical Records, electronic Trial Master File, Microsoft Office Suite

Communication: Excellent verbal and written skills, Presentation, and Interpersonal skills, Problem Solver, Detail-Oriented, Flexible, Self-Starter,

PROFESSIONAL EXPERIENCE

Clinical Monitor (CRA)

USC - Alzheimer Therapeutic Research Institute (ATRI) - San Diego, CA June 2021 to July2024

Conducted site qualification, site initiation, interim monitoring, dug accountability and close-out visits, ensuring compliance with ICH-GCP, GPP, and protocol requirements. Scheduled and managed budget for trips.

Assessed site processes, performed Source Document Review, and verified clinical data accuracy and completeness in CRFs.

Managed query resolution both remotely and on-site, providing guidance to site staff and driving closure within agreed timelines. Developed action plans in coordination with site staff.

Verified site compliance with electronic data capture requirements and IP inventory management, including reconciliation, storage, and security.

Reviewed Investigator Site File (ISF) and reconciled with the Trial Master File (TMF) for accuracy, timeliness, and completeness.

Documented site activities through confirmation letters, follow-up letters, trip reports, and communication logs.

Supported subject/patient recruitment, retention, and awareness strategies, entering data into tracking systems as required.

Acted as primary liaison with study site personnel, ensuring training and compliance with project-specific requirements.

Prepared for and attended Investigator Meetings, sponsor face-to-face meetings, clinical training sessions according to the project specific requirements and clinical monitoring/project staff meetings.

Provided guidance towards audit readiness standards, supporting preparation and follow-up actions.

Verified the informed consent process, demonstrated diligence in protecting the confidentiality of subjects and assessing factors affecting data integrity.

Trained junior staff and collaborated with vendors, MSLs, and local country staff.

Clinical Research Coordinator 2

Stanford University – Stanford Center for Clinical Research – Palo Alto, CA Sep 2020 to June 2021

Applied site management expertise to oversee investigator-initiated multisite COVID trials, ensuring seamless operations and 100% protocol adherence.

Applied keen problem-solving skills to develop effective strategies for patient recruitment and retention in various clinical studies

KEY ACHIEVEMENTS:

Achieved 100% recruitment targets through strategic patient recruitment and enrollment initiatives.

Played a pivotal role in the submission of 2 IND applications, facilitating effective communication between study chairs and participating sites.

Research Specialist

Georgetown University Lombardi Comprehensive Cancer center – DC Jun 2019 to Sep 2020

Directed a team overseeing the start-up and maintenance of 11 Phase I-IV clinical trials, in the Hematology-Oncology team ensuring compliance and precise data collection.

KEY ACHIEVEMENTS:

Fostered collaboration among diverse stakeholders, achieving a 20% increase in study enrollment and 100% on-time project completion.

Clinical Data Associate

Crown Hills Enterprises - Nottingham, MD June 2018 to June 2019

Supported clinical trials for CRO by providing meticulous data management. Designed and maintained databases, queries, reports; performed data entry, data reviews and supported database audits.

CLINICAL EXPERIENCE

Medical Officer October 2016 - April 2018

Lagos State University Teaching Hospital - Lagos, Nigeria

Medical Officer August 2012 - August 2015

National Neuropsychiatry Hospital - Lagos, Nigeria

Medical Doctor Nov 2011 - November 2012

Borsod-Abauj-Zemplen County Hospital - Miskolc, Hungary

Education and Certifications

Doctor of Medicine Nov 2011

University of Szeged, Hungary

Harvard Medical School Postgraduate Medical Education, Global Clinical Scholars Research Training Program, 1-year Certificate Program (2022-2023) Jan 2022

Harvard Medical School, Boston MA

Certified Clinical Research Associate (CCRA) May 2024

Association of Clinical Research Professionals (ACRP)

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