Clinical Research Quality & Compliance Leader

ANATALIO E. REYES JR., MS

Certified Clinical Research Professional

Contact Information

Address: **** ******* *****, ** *****, Maryland 20646 E-mail: **********@*******.***

Phone: 410-***-****

LICENSES & CERTIFICATIONS

• Certified Clinical Research Professional, Society of Clinical Research Associates

(SOCRA), effective until November 1, 2027.

• Certification in Regulatory Affairs: Pharmaceuticals, Regulatory Affairs Professionals Society (2022)

• Certification in Regulatory Requirements for Medical Device, University of California, Irvine (2005)

• Clinical Laboratory Scientist, State of California (1994) EDUCATION

• Cambridge College, New England Institute of Business, MS in Quality Systems Management

• Far Eastern University, BS in Medical Technology

• Department of Defense, US Navy – Advanced Medical Laboratory Technician SUMMARY OF EXPERIENCE

• Certified Clinical Research Professional with 15 years of experience in Clinical Quality Assurance (CQA), regulatory compliance, and clinical operations.

• Conducted global clinical site audits across phases I-IV, ensuring compliance with FDA and ICH guidelines and regulations.

• Performed audits of the electronic Trial Master File (eTMF) and archiving processes to confirm preparedness for FDA inspections.

• Proven ability to conduct internal and external audits, ensuring adherence to ICH GCP guidelines and FDA regulatory standards.

• Performed audits of clinical sites and vendors across private and government sectors, conducting facility tours, SOP reviews, personnel training assessments, and interviews of investigators and staff to evaluate regulatory adherence.

• Successfully represented clients and sites in FDA audits, site qualification visits, and securing approvals for clinical trial participation and vendor qualifications prior to engaging their services.

• Led Clinical Site Quality Management Programs (CQMP) for the National Institute of Allergy and Infectious Diseases, Division of Microbiology and Infectious Diseases

(DMID), ensuring compliance with ICH E-6 GCP and federal regulations.

• Managed a CQMP review team, overseeing 152 protocol-specific CQMPs and fifty site- specific CQMPs with 100% on-time delivery.

• Conducts audits of monitors and monitoring processes to ensure appropriate procedures and documentation were reviewed as defined in Manual of procedures, Monitoring manual and the Protocol.

• Assigned as the quality person in the Regulatory Support Center for the National Institute of Allergy and Infectious Diseases, Department of AIDS, overseeing the review and approval of unplanned and planned deviations submitted in the company’s quality management system, MasterControl.

• Review Corrective Action and Preventive Action (CAPA) plans.

• Review and approve internal Standard Operating Procedures (SOPs), Corporate Work Instructions, and Project-Specific Procedures using the Quality Management System, MasterControl.

• Designed and implemented tailored training programs for staff, aligned with their specific roles and responsibilities.

• Monitor and ensure staff training compliance by tracking their progress in completing required training programs.

• Hosted and passed regulatory inspections by FDA, JCAHO, and AAB, demonstrating excellence in clinical laboratory compliance.

• Also experienced as a Medical Technologist, specializing in quality control (QC) testing for new reagent batches, adhering to Good Laboratory Practice (GLP) guidelines. Skilled in hematology, chemistry analysis, coagulation, blood banking, parasitology, and microbiology testing, with expertise in urine and cerebrospinal fluid analysis, cell counts, sedimentation rate, and quantitative protein assessments.

• Holds an active U.S. Department of State Security Clearance through 2029. EXPERIENCE

Manager, Quality Assurance

Technical Resources International, Inc. (TRI), A Full-Service Clinical Research Organization

(CRO)

Apr 2022–Jul 2025

• Lead domestic and international clinical site audits across phases I-IV, ensuring compliance with FDA and ICH guidelines and regulations.

• Conduct internal audits and mentor junior auditors to enhance team capabilities

• Oversee client and vendor audits, ensuring adherence to quality standards.

• Performed audits of the electronic Trial Master File (eTMF) and archiving process to ensure readiness for FDA inspections.

• Serve as quality subject matter expert in stakeholder meetings, promoting a culture of compliance through staff training and Quality Management System (QMS) enhancement.

• Led a 7-member Clinical Quality Management Plan (CQMP) review team for DMID- CROMS, overseeing initial and revised CQMPs submitted by clinical trial sites for DMID-funded research.

• Uploaded approved CQMPs to the company’s portal, Document Library, and maintain CQMP Status Reports for monitors, ensuring presence of the plan and with the correct version.

• Created and provided monthly, quarterly, and annual CROMS Reports for QA metrics & Goals in the Clinical Quality Management Tas Area.

• Evaluate and approve DAIDS RSC deviations, tracking deliverables and overseeing the implementation of corrective actions to maintain operational integrity. Manager Quality Assurance

General Dynamics Information Technology, Inc. (GDIT) 2019–2022

• Provided comprehensive on-site clinical trial monitoring and auditing in support of the Naval Medical Research Center (NMRC) as part of Quality Assurance (QA) procedures. Implemented and maintained QA and Quality Control (QC) measures, ensuring trials were conducted, recorded, and reported in alignment with protocols, Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and regulatory requirements.

• Verified trial subjects’ rights and well-being, ensuring data integrity by adhering to Good Documentation Practices (GDP) principles, confirming data was attributable, legible, contemporaneous, original, and accurate. Assessed Investigational Product (IP) integrity upon receipt, confirming shipping details matched packing slip records, including lot numbers, quantities, timestamps, and condition upon arrival.

• Performed vendor audits, including assessments of LabCorp diagnostic facility

(Baltimore, MD) for sample collection and reporting and biorepository/pharmaceutical company (Frederick, MD) for sample storage. Conducted computer validation (hardware and software) to ensure reliability before trial data collection. Additionally, supported Uniformed Services University of Health Sciences (USU), Bethesda, MD, in the implementation of COVID-19 observational studies.

Quality Assurance Manager

Henry M. Jackson Foundation

2009–2019

• Provided on-site quality oversight at the Clinical Trials Center (CTC) for the Naval Medical Research Center (NMRC), ensuring clinical trials adhered to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) regulations, and ICH guidelines. Supported CTC operations by maintaining regulatory documentation, conducting regulatory inspections, internal audits, qualifying vendors, and facilitating staff training.

• Served as CTC Lead Representative during the Department of the Navy (DON) Human Research Protection Program (HRPP) inspection and audit, earning high marks for compliance and quality management.

Medical Technologist

Doctors Community Hospital, Lanham, MD

2007–2010

• Validated new analytical equipment through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) procedures, ensuring accuracy and regulatory compliance. Conducted Quality Control (QC) testing on new reagent batches, verifying performance against manufacturer-set acceptable parameters under Good Laboratory Practice (GLP) guidelines.

• Performed microbiology, hematology, and chemistry analyses, including urine and cerebrospinal fluid testing, cell counts, sedimentation rates, and quantitative protein assessments, ensuring precision in diagnostic evaluations. United States Navy

1993-2009

• With extensive experience across clinical research, laboratory operations, and quality assurance, supported chemical, biological, and radiological consequence management for the U.S. Marine Corps Chemical Biological Incident Response Force (CBIRF), leading terrorist incident response and leadership training for DoD, civilian, and allied organizations.

• Operated and maintained DoD Bio-Safety Level (BSL) 3 laboratories at the Naval Medical Research Center (NMRC), helping advance biological weapons detection training for Navy personnel.

• Managed blood bank operations and led Good Laboratory Practice (GLP) audits at the Naval Hospital Naples, Italy, ensuring successful FDA inspection completion.

• Developed and optimized automated human leukocyte antigen (HLA) typing procedures at the NMRC Bone Marrow Research Program, improving sample processing accuracy.

• Oversaw vendor qualifications and laboratory logistics at the Naval Hospital Pathology Department, ensuring efficient operations and regulatory compliance. PROFESSIONAL DEVELOPMENT

• Good Clinical Practice (GCP) Training – Collaborative Institutional Training Initiative

(CITI Program)

• CITI Human Subject Protection Training

• Regulatory Oversight of Extramural Human Subject Research – CITI Program

• Pharmaceuticals Certificate Program – Regulatory Affairs Professional Society

• Pharmaceutical Quality Symposium – FDA

• Generic Drugs Forum – FDA

• Quality Tools Training – Six Sigma

• Lean Six Sigma Yellow Belt Training – Walter Reed National Military Medical Center

• Annual FDA Conference (CDER & SBIA)

• Data Integrity in Global Clinical Trials – FDA & MHRA GCP Workshop

• Defining Quality in Clinical Trial Conduct – Association of Clinical Research Professionals

• HIPAA and Privacy Act Training – Defense Health Agency

• Good Clinical Laboratory Practice (GCLP) – Naval Medical Research Center/Walter Reed Army Institute of Research

• Lean Six Sigma White Belt Course – Naval Education and Training Command

• Basic Computer Validation – Society of Quality Assurance

• Introduction to Medical Device Law and Regulation – The Food and Drug Law Institute

• Excellence in DoD Human Research Protection Programs – Undersecretary of Defense

• Medical Device Quality Systems Management – University of California, Irvine COMPUTER SKILLS

• Hardware: Intel-based PC, Apple Macintosh

• Software: Microsoft Office (Word, Excel, Power Point, Outlook), MS Teams

• Quality Management Software: MasterControl System AWARDS/HONORS

• Richard C. Knudsen Award by American Biological Safety Association (ABSA) MEMBERSHIPS/ PROFESSIONAL ASSOCIATIONS

• The Society of Clinical Research Associates, Inc 2024-2027 SELECTED PUBLICATIONS

1. Graydon E., Conner T., Dunham, Olsen C., Goguet E., Si’Ana A. Coggins, Rekedal M., Samuels E., Belinda Jackson-Thompson, Moser M., Lindrose A., Hollis-Perry M., Wang G., Maiolatesi S., Alcorta Y., Reyes A., & et al. (2023). Natural killer cells and BNT162b2 mRNA vaccine reactogenicity and durability. Frontier Immunology, Volume 14-2023.

2. Goguet E., Powers J. III, Olsen C., Tribble D., Davies J., Illinik L., Jackson-Thompson B., Hollis-Perry M., Maiolatesi S., Pollett S., Duplessis C., Wang G., Ramsey K., Reyes A., & et al. (2022). Prospective Assessment of Symptoms to Evaluate Asymptomatic SARS-CoV-2 Infections in a Cohort of Health Care Workers. Open forum Infectious Diseases, Oxford University Press (2022) 9(3)

3. Laing E., Weiss C., Samuels E., Coggins S., Wang W., Wang R., Vassell R., Sterling S., Tso M., Conner T., Goguet E., Moser M., Jackson-Thompson B., Illinik L., Davies J., Ortega O., Parmelee E., Hollis-Perry M., Maiolatesi S., Wang G., Ramsey K., Reyes A.,

& et al. (2022). Durability of Antibody Response and Frequency of SARS-CoV-2 Infection 6 Months after COVID-19 Vaccination in Healthcare Workers. Emerging Infectious Diseases, 28(4)

4. Sklar, M. J., Maiolatesi, S., Patterson, N., Sedegah, M., Limbach, K., Teneza-Mora, N., Chuang, I., Hollis-Perry, K. M., Banania, J. G., Guzman, I., Ganesha, H., Reyes, S., Hollingdale, M. R., Wong, M., Lindstrom, A., Reyes, A., & et al. (2021). A three-antigen Plasmodium falciparum DNA prime-Adenovirus boost malaria vaccine regimen is superior to a two-antigen regimen and protects against controlled human malaria infection in healthy malaria-naïve adults. PLoS One,(2021) 16(9), e0256980. 5. Coggins, S. A., Laing, E. D., Olsen, C. H., Goguet, E., Moser, M., Jackson-Thompson, B. M., Samuels, E. C., Pollett, S. D., Triblle, D. R., Davies, J., Illinik, L., Hollis-Perry, M., Maiolatesi, S. E., Duplessis, C. A., Ramsey, K. F., Reyes, A. E., & et al. (2021). Adverse effects and antibody titers in response to the BNT162b2 mRNA COVID-19 vaccine in a prospective study of healthcare workers. Open Forum Infectious Diseases, 9(1), ofab575. 6. Jackson-Thompson, B. M., Goguet, E., Laing, E. D., Olsen, C. H., Pollett, S., Hollis- Perry, K. M., Maiolatesi, S. E., Illinik, L., Ramsey, K. F., Reyes, A. E., & et al. (2021). Prospective assessment of SARS-CoV-2 Seroconversion (PASS) study: an observational cohort study of SARS-CoV-2 infection and vaccination in health care workers. BMC Infectious Diseases, 21(1), 544.

7. Lyke, K. E., Singer, A., Berry, A. A., Reyes, S., Chakravarty, S., James, E. R., Billingsley, P. F., Gunasekera, A., Manoj, A., Murshedkar, T., Laurens, M. B., Church, W. P., Garver Baldwin, L. S., Sedegah, M., Banania, G., Ganesha, H., Guzman, I., Reyes, A., & et al. (2020). Multidose priming and delayed boosting improve PfSPZ vaccine efficacy against heterologous P. falciparum controlled human malaria infection. Clinical Infectious Disease, 73(7), e2424–e2435.

8. Hickey, B., Teneza-Mora, N., Lumsden, J., Reyes, S., Sedegah, M., Garver, L., Hollingdale, M. R., Banania, J. G., Ganeshan, H., Dowler, M., Reyes, A., & et al. (2020). IMRAS–A clinical trial of mosquito-bite immunization with live, radiation-attenuated P. falciparum sporozoites; Impact of immunization parameters on protective efficacy and generation of a repository of immunologic reagents. PLoS One, 15(6), e)233840. 9. Tamminga, C., Sedegah, M., Maiolatesi, S., Fedders, C., Reyes, S., Reyes, A., et al.

(2013). Human adenovirus 5-vectored Plasmodium falciparum NMRC-M3V-Ad-PfCA vaccine encoding CSP and AMA1 is safe, well-tolerated and immunogenic but does not protect against controlled human malaria infection. Human Vaccines & Immunotherapeutics, 9(10), 2165–2177.

10. Turnbull, P. C. B., Reyes, A. E., Chute, M. D., & Mateczun, A. J. (2008). Effectiveness of UV exposure of items contaminated with anthrax spores in a Class 2 biosafety cabinet and a Biosafety Level 3 pass-box. Applied Biosafety, 13(3), 164–168. Received ABSA Richard C. Knudsen Award (2009).

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