Frank Ukata
Houston
Summary
Dynamic clinical research professional with extensive experience at Johnson & Johnson, excelling in clinical trial management and regulatory compliance. Proven track record of enhancing site compliance by 22% and optimizing patient recruitment strategies. Adept in cross-functional team leadership and problem-solving, ensuring successful trial execution and adherence to GCP standards.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Lead Clinical Research Associate
Johnson & Johnson
03.2024 - Current
- Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
- Drafted agendas, minutes and other meeting materials for Investigator Meetings or Advisory Boards.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Provided training on GCP standards to new personnel or existing staff members.
- Developed and managed budgets for clinical trials according to study protocols.
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
Senior Clinical Research Associate
Genova BioPharma
01.2019 - 03.2024
- Company Overview: Genova is a mid-sized biopharmaceutical firm focusing on oncology and immunology therapeutics in early-to-late phase clinical trials.
- Managed over 15 multi-site Phase II/III trials in Oncology and Autoimmune diseases across U.S. and EU regions.
- Improved site compliance rates by 22% by implementing targeted monitoring plans and site training protocols.
- Led site initiation, interim monitoring, and close-out visits, overseeing 30+ trial sites annually.
- Collaborated with project managers, data managers, and medical monitors to resolve 100+ protocol deviations.
- Utilized Medidata RAVE and Oracle Siebel to track visit reports, action items, and site performance metrics.
- Genova is a mid-sized biopharmaceutical firm focusing on oncology and immunology therapeutics in early-to-late phase clinical trials.
Clinical Research Associate II
Proxima Clinical Research
12.2016 - 01.2019
Clinical Research Associate I
Parexel
10.2014 - 12.2016
- Company Overview: PharmaBridge is a full-service CRO supporting clinical research in Neurology and Rare Disease pipelines.
- Supported cross-functional clinical operations team on global studies with budgets exceeding $20M.
- Performed 100% SDV and ensured regulatory documentation was audit-ready across all study sites.
- Reduced patient dropout rates by 18% through improved site communication and patient engagement strategies.
- Monitored adherence to FDA regulations, resulting in zero major audit findings in three sponsor audits.
- Mentored junior CRAs and assisted in protocol and informed consent development.
- PharmaBridge is a full-service CRO supporting clinical research in Neurology and Rare Disease pipelines.
Clinical Research Coordinator
MD Anderson Cancer Center Hospital
02.2012 - 10.2014
- Company Overview: Academic medical center conducting investigator-initiated and sponsored research trials in cardiology and endocrinology.
- Coordinated daily clinical operations for up to 6 concurrent studies including subject screening, consent, and AE reporting.
- Trained new study staff on EDC systems and clinical protocol SOPs.
- Developed site performance dashboards that helped increase recruitment efficiency by 25%.
- Academic medical center conducting investigator-initiated and sponsored research trials in cardiology and endocrinology.
Education
MBA - Project Management
American InterContinental University
Bachelor of Science - Microbiology
University of Jos
Skills
- Clinical Trial Management
- Risk-Based Monitoring (RBM)
- FDA, EMA, ICH-GCP Compliance
- Patient Recruitment & Retention
- Vendor Oversight & Site Management
- Data Collection & Quality Assurance
- Project Lifecycle Management
- Cross-Functional Team Leadership
- ETMF & CTMS Systems (Medidata, Veeva Vault, Oracle Siebel)
- Regulatory Submissions & Protocol Adherence
- Strong Written & Verbal Communication
- Problem-Solving & Process Optimization
Therapeutic Area
- Oncology: Solid Tumor, Lymphoma, Myeloma, T-cell therapy, Breast Cancer
- Infectious Disease: Covid-19(Vaccine), HPV, AIDS, Seasonal Flu
- Neuroscience: Cerebral Palsy, Multiple Sclerosis, Idiopathy Generalized Epilepsy
- Rare Disease: Auto-Immune Disease, Cystic Fibrosis, Duchenne Muscular Dystrophy (DMD)
Certification
- Certified Clinical Research Professional (CCRP), Society of Clinical Research Associates (SoCRA), 01/21
- ICH-GCP Certification, National Institute on Drug Abuse Clinical Trials Network, 01/23
- Human Subjects Protection Training, CITI Program, 01/22
Accomplishments
- Developed and implemented a centralized monitoring plan that reduced monitoring costs by 28% across three global trials.
- Recognized by senior leadership with a 'CRA of the Year' Award in 2022 for outstanding data quality and protocol compliance.
- Published: 'Best Practices in Remote Site Monitoring' in Clinical Research Monitor Journal, 2023.
- Spearheaded cross-functional training initiative that increased trial team efficiency and reduced study startup times by 15%.
Industry Specific Expertise
Risk-Based Monitoring, Central Monitoring, Source Data Verification (SDV), ICH-GCP, FDA 21 CFR Part 11, EU Clinical Trials Regulation, Medidata RAVE, Oracle Siebel CTMS, Veeva Vault, Clincapture, OpenClinica
Timeline
Lead Clinical Research Associate
Johnson & Johnson
03.2024 - Current
Senior Clinical Research Associate
Genova BioPharma
01.2019 - 03.2024
Clinical Research Associate II
Proxima Clinical Research
12.2016 - 01.2019
Clinical Research Associate I
Parexel
10.2014 - 12.2016
Clinical Research Coordinator
MD Anderson Cancer Center Hospital
02.2012 - 10.2014
MBA - Project Management
American InterContinental University
Bachelor of Science - Microbiology
University of Jos
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