Justin Scott Brathwaite

About Justin Scott Brathwaite

Currently a Clinical Research Associate I at Fortrea with an extensive background in Study Startup Skilled in all areas of regulatory study startup, which includes processing protocol amendments, negotiating contract/budgets, projecting study timelines, feasibility, study audits, TMF, and Clinical Trial Management Systems (CTMS). Received more than 14 company (Achieving Covance Excellence) awards for activating research sites quickly to achieve deliverables and ready to enroll dates. 2022 & 2023 Clinical-Researcher of The Year the Americas competition for Study startup 2022 Research Revolution Scholarship Winner by for Florence healthcareAwarded team of the month by senior leadership at LabCorp for successful study startup on two phase II trials. Experience in the following indications Cardiac Sarcoidosis Solid Tumors Non-Small Cell Lung Cancer Metastatic Gastrointestinal Stromal Tumors Chronic Pulmonary Sarcoidosis Psoriatic Arthritis Refractory Multiple Myeloma Non-Small Cell Lung Cancer Non-Hodgkin Lymphoma Prostate Cancer Type I Diabetes Additional Skills Trained in FDA regulations 21 CFR, Parts 11,50,54, and 56; knowledgeable in clinical trial operations from feasibility through closeout. Skillful in maintaining the regulatory binder, which houses essential documents such as: 1572, source documents, DOA, training Logs, ICF, SAE forms, Financial Disclosures, Subject Enrollment & Identification Logs, Case Report Forms (CRF), Procedure manuals, Standard Operating Procedures (SOP), Site Visit Logs, Correspondences, and other Investigator Site File (ISF) document; ICF Development

Experience

1. Clinical Research Associate i

   Fortrea

   Jan 2026 — Present

   Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned • Responsible for all aspects of site management as prescribed in the project plans • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review • Monitor data for missing or implausible data • Ensure the resources of the sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy • Ensure audit readiness at the site level • Prepare accurate and timely trip reports

Education

• University of Jamestown

  Doctor of Philosophy - PhD, Clinical Research

• Questrom School of Business, Boston University

  Master of Business Administration - MBA, Business Administration and Management, General

• Columbia University

  Bachelor of Arts (A.B), Chemistry

Skills

• Statistics
• Pcr
• Polymerase Chain Reaction (Pcr)
• Clinical Research
• Public Speaking
• Scientific Writing
• Agarose Gel Electrophoresis
• Research
• Powerpoint
• Microsoft Excel
• Community Outreach
• Genotyping
• Microsoft Word
• Teaching
• Social Media
• Organization Skills
• Event Planning
• Data Analysis
• Leadership
• Microsoft Office
• Rt-Pcr
• Editing
• Rna Isolation