Clinical Operations Leader with Regulatory Excellence

Rafael L. Wong, MS, CRPM, CTBS, CTM

San Antonio, Texas 210-***-**** ******.****@*******.***

March 27, 2026

Hiring Manager

Pinnacle Clinical Research

Clinical Operations Manager

Dear Hiring Manager,

I am writing to apply for the Clinical Operations Manager position at Pinnacle Clinical Research. With a career built on managing multi-study clinical research sites, directly supervising CRC teams, and maintaining rigorous GCP and FDA regulatory compliance, I am confident my background aligns closely with what Pinnacle needs in this role. At Medical Center Ophthalmology Associates (MCOA), I oversaw daily operations across 12 concurrent Phase 2-3 clinical trials, supervised a team of 10 Clinical Research Coordinators and 1 Regulatory Specialist, and served as the primary liaison with sponsors and CROs including Genentech, Allergan, Bausch + Lomb, and the National Eye Institute. I personally prepared for and facilitated 10-12 monitoring visits per 4-6 week cycle, maintained 100% on-time patient visit completion across 8 simultaneous active trials, and achieved a #2 national recruitment ranking across two retina indications. Across that tenure and throughout my career, I have never received an FDA 483 observation - a record I consider the defining standard of compliant site operations. At Phoenix Clinical Research, I advanced from CRC to CRA and Clinical QA Lead, directly executing SDV/SDR, risk-based monitoring, and CAPA programs - skills directly applicable to the supervisory and compliance responsibilities this role demands. My QA leadership experience includes CAPA program ownership, SOP development, and inspection readiness preparation, complemented by hands-on proficiency with Medidata Rave, Veeva Vault, and Oracle CTMS platforms.

I thrive in multi-study environments with competing priorities, and I understand what it takes to build and lead a high-performing CRC team while keeping research operations sponsor-ready at all times. I would welcome the opportunity to bring this experience to Pinnacle Clinical Research. Sincerely,

Rafael L. Wong, MS, CRPM, CTBS, CTM

RAFAEL L. WONG, MS, CRPM, CTBS, CTM

San Antonio, Texas 210-***-**** ******.****@*******.*** GCP · FDA 21 CFR · ICH E6(R3) · Multi-Site Clinical Trial Management · CRC Team Supervision PROFESSIONAL SUMMARY

Clinical Research Operations Manager with demonstrated expertise in multi-study site management, Clinical Research Coordinator (CRC) supervision, and GCP regulatory compliance across Phase 2-3 ophthalmology trials, oncology, and biologics therapeutics. Proven record as the primary sponsor and CRO liaison for 12 concurrent multi-center trials — achieving top-2 national recruitment rankings, zero FDA 483 observations across full career, and 100% on-time patient visit completion. Certified Clinical Research Project Manager (CRPM), Certified Trial Manager (CTM), and Certified Tissue Bank Specialist (CTBS) with additional credentials in Six Sigma Black Belt methodology and ICH E6(R3) Good Clinical Practice.

CORE COMPETENCIES

Multi-Study Site Operations CRC Team Supervision Sponsor & CRO Liaison GCP & FDA Regulatory Compliance Protocol Deviation & CAPA Management Monitor Visit Facilitation Informed Consent Oversight AE/SAE Reporting Subject Recruitment & Screening eTMF & CRF Management ICH E6(R3) Compliance Process Improvement — Six Sigma BB PROFESSIONAL EXPERIENCE

Clinical Research Consultant & Project Manager

Eleven11co LLC Eleven11biologics LLC San Antonio,TX November 2022 – Present

-Managed clinical research project oversight for Phase I-III biotech clients in oncology, ophthalmology, and wound care biologics — coordinating study timelines, vendor relationships, and regulatory deliverables across concurrent engagements.

-Served as primary sponsor and CRO liaison — reviewed vendor performance against contractual KPIs and managed corrective action requests for quality agreement non-conformances across 8 audited testing laboratories and processing CDMOs.

-Led GCP audit programs including investigator site audits, vendor audits, and internal system reviews — developed CAPA plans achieving 100% closure of 47 identified quality deficiencies within 6 months.

-Developed and maintained SOP libraries, quality plans, and eTMF governance frameworks aligned with ICH E6(R3) and FDA 21 CFR Parts 312 and 1271 — ensuring inspection-ready documentation at all times.

-Designed and delivered site initiation training programs for CRC staff across multi-site launch onboarding engagements — including protocol education, delegation authority requirements, and GCP compliance reinforcement. Regional Clinical Operations Manager

Southwest Transplant Alliance (STA) Dallas & ElPaso, TX May 2022 – October 2022 Note: Position eliminated — tissue recovery division dissolved during CMS-driven organizational restructuring.

-Directed regional clinical operations across 270 hospitals and 89 Texas counties — leading 40 Surgical Procurement Technicians, 7 Team Leads, and 20+ Referral Intake/Transplant Coordinators while maintaining regulatory compliance with FDA 21 CFR Part 1271 and AATB Standards.

-Implemented accelerated staff training program — reducing independent sign-off timeline by 83.3% (18 months to 3 months) and generating approximately $65,000 in average departmental savings per technician. Senior Medical Director Designee CAPA Program Lead San Antonio Eye and Tissue Bank (SAETB) San Antonio,TX November 2019 – May 2022

-Led quality management and regulatory compliance for GTP-regulated biological product operations — supervised 22 staff, owned CAPA program from deviation identification through root cause analysis and effectiveness verification, achieving 100% audit compliance across 2.5-year tenure.

-Served as primary FDA and AATB regulatory inspection liaison across multiple accreditation cycles — coordinated facility preparations, managed audit finding responses, and hosted inspection activities with zero regulatory findings.

-Implemented MasterControl eQMS — developed and maintained SOP library of 18 SOPs, 200+ batch records annually, and 50+ change controls; reduced document retrieval time by 65% and enabled real-time audit readiness.

-Oversaw vendor qualification audits (8 audits) and surveillance audits (15 audits) across infectious disease testing laboratories and tissue processing CDMOs — identified 12 quality agreement non-conformances and achieved 92% vendor compliance improvement.

-Conducted retrospective data analysis and designed predictive analytics algorithm — implemented protocol changes improving corneal transplant success rate from 75% to 96% over a 4-year tracking period. CRC III CRA & Clinical QA Lead

Phoenix Clinical Research San Antonio, TX June 2013 – January 2016

-Advanced from CRC III to on-site and remote CRA — executed SDV/SDR per ICH E6(R3) §5.18, risk-based monitoring per ICH Q9, and IMP/IP oversight including storage accountability and chain of custody across Phase 1-2 oncology and ophthalmology trials.

-Promoted to Clinical QA Lead — designed and executed QA audit program per ICH Q10, owned CAPA system from RCA through effectiveness verification, led inspection readiness preparation including mock FDA inspections, and developed QMS SOPs and work instructions.

-Supervised CRF completion, adverse event documentation, and protocol deviation reporting — ensured IRB and sponsor reporting timelines were met per ICH E6(R3) §4.11 and FDA 21 CFR Part 312.

-Mentored CRC I and CRC II staff, provided GCP training reinforcement, and led site training during investigator meetings and protocol amendments.

Clinical Operations Manager Site Director of Clinical Research — Ophthalmology Medical Center Ophthalmology Associates (MCOA) San Antonio, TX February 2016 – January 2017 Recruited back to MCOA by senior leadership following progression at Phoenix Clinical Research.

-Supervised daily operations for 12 concurrent Phase 2-3 ophthalmology clinical trials across 5 Principal Investigators and 12 Sub-Investigators — directly overseeing 10 CRCs and 1 Regulatory Specialist in protocol adherence, case report form completion, and study documentation.

-Served as primary liaison with sponsors and CROs including Genentech, Allergan, Bausch + Lomb, and DRCR/NEI — coordinated 10-12 monitoring visits per 4-6 week cycle, prepared site for visits, and ensured timely CAPA implementation following monitoring findings.

-Supervised subject screening, informed consent execution, appointment scheduling, and visit implementation for 200+ enrolled participants — overseeing phlebotomy, specimen processing, and biological sample shipping per IATA and protocol requirements.

-Maintained 100% on-time patient visit completion rate across 8 concurrent active trials — coordinating competing study priorities and enrollment deadlines across a 5-PI research department.

-Achieved #2 national recruitment ranking of 52 participating sites (1st of 12 in Texas) for Diabetic Retinopathy and #2 of 36 sites (1st of 10 in Texas) for Diabetic Macular Edema — demonstrating exceptional patient recruitment and retention performance.

-Ensured continuous audit readiness through rigorous eTMF management, essential document review, and GCP compliance — hosted 2 FDA site inspections with zero 483 observations.

-Documented and reported AEs, SAEs, and protocol deviations per ICH E6(R3) §4.11 and 21 CFR §312.32 — evaluated root causes, implemented corrective actions, and ensured IRB and sponsor notification within required timelines.

-Led site portfolio expansion from 8 to 18 active trials within 12 months — growing department revenue 200% ($400K to $1.2M) through sponsor relationship development and operational excellence. Senior CRC & Assistant Research PM COT Surgical Technician Medical Center Ophthalmology Associates (MCOA) San Antonio, TX April 2005 – May 2013 Concurrent with Graduate Studies — MS Cellular Biology, UTSA (2011-2013). Promoted from COT/Surgical Tech through CRC I, CRC II, CRC III to Senior CRC & Assistant Research PM over 8-year tenure.

-Conducted SDV/SDR during sponsor CRO co-monitoring visits (Genentech, Allergan, Bausch + Lomb, Bayer, DRCR/NEI) — ensured source document alignment, protocol compliance, and GCP adherence across Phase 2-3 ophthalmology trials.

-Managed protocol I/E criteria screening, informed consent execution, AE/SAE documentation, and IMP/IP accountability — supported 2 FDA site inspections with zero observations and participated in study-level CAPA follow-up.

-Lead researcher on 4 national ophthalmology publications — ASRS Honor Award recipient (2006) for Vitrase

(hyaluronidase) for Vitreous Hemorrhage in Proliferative Diabetic Retinopathy. EDUCATION

Master of Science (MS) — Cellular Biology

Concentration: Physiology, Microbiology & Infectious Disease University of Texas at San Antonio (UTSA) 2013 Bachelor of Science (BS) — Cellular Biology

Concentration: Biomedical Sciences University of Texas at San Antonio (UTSA) 2011 CERTIFICATIONS & PROFESSIONAL CREDENTIALS

-Certified Tissue Bank Specialist (CTBS) — AATB Active

-Clinical Research Project Manager (CRPM) — VIARIES 2023

-Clinical Trial Manager (CTM) — VIARIES 2023

-Six Sigma Black Belt — Level III — Management & Strategy Institute 2023

-Good Clinical Practice (GCP) — Novartis 2026

-Clinical Trial Operations Specialization — Johns Hopkins University 2026

-NIH GCP Certification — 2023

-CCRP — Certified Clinical Research Professional — SOCRA In Progress (Target Q2 2026)

-ACRP-CP — Clinical Research Professional — ACRP In Progress (Target Q3 2026) TECHNICAL SKILLS

EDC & CTMS:Medidata Rave, Veeva Vault, Oracle CTMS/Siebel,OnCore, Castor EDC, OpenClinica, CRIO, Clinical Conductor

eQMS:MasterControl, Veeva QualityDocs, TrackWise

Regulatory Frameworks:FDA 21 CFR Parts 11, 50, 54,56, 312, 600, 1271 ICH E6(R3) GCP, GMP, GTP, GDP AATB & EBAA Standards

Project Management:MS Project, MS Office Suite, SalesforceCRM, Budget Forecasting, KPI Dashboards, Enrollment Tracking

Therapeutic Areas:Ophthalmology Diabetic Macular Edema Retinal Vein Occlusion Proliferative Diabetic Retinopathy Oncology Biologics Wound Care

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