Clinical Research Associate

SAMUEL FADIYA

******.**********@*****.*** 443-***-**** Baltimore, MD

Summary

Lead Clinical Research Associate (LCRA) with 5+ years of site management experience, including 2+ years of field monitoring across cardiovascular, oncology, dermatology, endocrinology, and medical device trials. Proven record of inspection readiness with zero audit findings, expertise in Medidata RAVE, and hands-on experience implementing enrollment strategies and overseeing investigational product accountability. Adept at mentoring CRAs, liaising with Clinical Project Leads, and executing vendor oversight. Advanced knowledge of ICH-GCP, FDA regulations, ISO standards, and ethical compliance, with a track record of measurable improvements in data quality, site performance, and compliance.

Skills

Site Management & Risk-Based Monitoring

Cardiovascular & Device Trial Oversight (including IVD-adjacent)

Medidata RAVE eCRFs Data Quality & Query

Resolution

Audit/Inspection Readiness (FDA, Sponsor, IRB)

Enrollment & Retention Strategy Implementation

CAPA Management & Monitoring Visit Report (MVR)

QC

Vendor Selection & Performance Oversight

CRA Mentorship & Team Leadership

Regulatory Submissions & Informed Consent

Compliance

Experience

George Clinical

Clinical Research Associate II

05/2023 - Present

Liaised directly with Clinical Project Leads across 6 US sites, mentoring 3 CRAs through co-monitoring and MVR coaching; reduced monitoring report discrepancies by 25%.

Maintained 100% TMF/ISF completeness, ensuring zero audit findings across sponsor and FDA inspections.

Spearheaded risk-based monitoring triggers and closed 2 CAPAs within 30 days (source doc lag, AE under-reporting).

Led UAT sessions for Medidata RAVE, influencing eCRF design updates that improved data accuracy and reduced query rates by 20%.

Partnered with Clinical Ops to evaluate and onboard central vendors

(ECG, ePRO), cutting site turnaround by 2.5 days on average. Alta Sciences

Clinical Research Associate I

04/2022 - 05/2023

Conducted site initiation, interim, and closeout visits across Phase I–II dermatology and device studies; sustained zero protocol deviations for IP handling.

Implemented recruitment playbooks (prescreen trackers, referral scripts), driving +18% enrollment across 4 active sites.

Performed QC of Monitoring Visit Reports (10+/quarter) for junior CRAs; reduced reporting error rate from 9% to 3%.

Coordinated vendor communication for labs and imaging, aligning deliverables with sponsor timelines.

Siropharm

Clinical Research Associate

02/2020 - 04/2022

Authored monitoring plan addendum on device accountability and temperature excursions; zero major findings on regulatory audit.

Supported IVD-adjacent workflows: reconciled central lab sample logistics and data flags; collaborated with data mgmt to align with analytical performance testing.

Resolved 95% of site queries within 48 hours, accelerating database lock. University of Texas Medical Branch Health

(UTMB)

Clinical Research Coordinator

02/2015 - 03/2019

Coordinated 6 concurrent Phase II–III oncology and cardiology trials; prepared and submitted IRB protocols, amendments, and continuing reviews.

Designed recruitment dashboards and referral pathways, increasing randomization rates by 20%.

Standardized informed consent verification, reducing consent errors by 40%.

Maintained e-regulatory files in OnCore and Epic; ensured continuous inspection readiness.

Education and Training

Federal University of Technology NG

Bachelor of Science in Engineering

Arizona State University Tempe, AZ

Master of Science in Clinical Research Management (Regulatory Science) Certifications

Project Management Professional (PMP) - PMI (2022)

Advanced ICH-GCP Certification (AGCPC) - CCRPS (2024)

GCP Certification - CITI (2024)

Clinical Research Associate Program - CITI (2024)

Basic Life Support (BLS) - American Health Training (2024) Therapeutic Areas

Oncology: Colon Cancer, Solid Tumor

Medical Device & Cardiology: Atherosclerosis, Arrhythmia

Dermatology: Atopic Dermatitis (Eczema), Psoriasis, Dermatitis, Alopecia

Gastroenterology: IBD, IBS, Celiac Disease

CNS: Alzheimer's, Parkinson’s Disease

Rare Disease: Myasthenia Gravis

Endocrinology: Diabetes, Obesity

Raritan, NJ

New Jersey

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