Clinical Research Operations Leader - Mayo Clinic Arizona

Guillermo Armando Barahona Hernandez, MPH, MBA

410-***-**** **************@*****.*** Scottsdale, AZ LinkedIn Profile PROFESSIONAL SUMMARY

A dedicated professional leveraging several years of progressive experience in clinical trial operations to oversee clinical research and trials, as well as to build and lead a high-performance clinical operations team performing duties by established protocols. History of facilitating progressive growth, seizing opportunities, strengthening operations, improving processes, and elevating output, quality, and patient satisfaction. Adept at leading high-value clinical research trials and providing patient-centric medical solutions to support patient wellbeing. Innate ability to excel in the face of adversity by creatively overcoming obstacles. SKILLS AND COMPETENCIES

• Time Management • Data Analysis • Oral & Written Communication

• Training & Development • Interpersonal Skills • Regulatory Compliance

• Continuous Improvement • Clinical Research • On-Boarding / Orientation

• Cross-Group Collaboration • Process Improvement • Organization & Flexibility

• Team Leadership • Protocol Implementation • Project Management

• Industry Trends • Attention to Detail • Research Operations Management

• Vendor Management • Documentation & Reporting • Study Design & Deployment

• Presenting & Facilitating • Records Maintenance • Employee Engagement & Morale

• Clinical Trial Supervision • Decision Making • Multitasking & Prioritizing PROFESSIONAL WORK EXPERIENCE

Research Program Coordinator, Mayo Clinic Arizona 2022-Present

• Coordinate the program's operations within the assigned Gastroenterology Division, efficiently directing resources and workloads to facilitate the realization of set objectives and strategies.

• Liaise with Scientific and Administrative leadership to develop strategic plans, program budgets, and process improvements.

• Serve as an intermediary between national and international consortium or program members, strengthening collaboration and coordinating with federal and industry sponsors and agencies on matters regarding Motility problems/illnesses.

• Maintain internal relationships with entities such as IRB, Compliance Offices, and Research Legal Contracts, and manage external collaborations with the FDA, NIH, and other key bodies.

• Function as the “go-to” resource for all issues and communications related to the Gastroenterology Division’s research activities and projects.

• Spearhead an innovative project utilizing AI to generate clinical notes from standardized questionnaires within the GI, Rheumatology, and Pulmonology divisions; build a strategic partnership with Google to improve the project’s capabilities, seamlessly integrating with the REDCap and EPIC systems.

• Provide coaching and mentorship to national and international researchers in the GI division to support their development as clinical research professionals.

• Oversee the research administrative base for the medium-sized research program, encompassing multicenter clinical trials and research groups, with national and international participation, while leading seven clinical trials, two multisite and five single sites.

Postdoctoral Fellow Neurogastroenterology, Department of Medicine, John Hopkins University 2018-2022

• Oversaw the informed consent process, effectively interacting with the Institutional Review Board (IRB) and facilitating discussions with research participants; answered participant inquiries related to the study to promote their safety and increase their comprehension of the process.

• Confirmed, amended consent forms were accurately implemented, and participant signatures were obtained, ensuring compliance with regulatory requirements and ethical standards.

• Developed effective and ongoing communications with sponsors, vendors, Contract Research Organizations (CROs), research participants, and Principal Investigators (PIs) to ensure seamless study operations.

• Screened subjects for eligibility using protocol-specific inclusion and exclusion criteria; accurately entered each potential participant’s eligibility or exclusion, driving the recruitment process.

• Leveraged extensive REDCap project design and management knowledge to ensure and facilitate efficient data collection and management.

GB

Guillermo Armando Barahona Hernandez, MPH, MBA

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PROFESSIONAL WORK EXPERIENCE CONTINUED

Postdoctoral Fellow Neurogastroenterology, Department of Medicine, John Hopkins University 2018-2022

• Screened subjects for eligibility using protocol-specific inclusion and exclusion criteria; accurately entered each potential participant’s eligibility or exclusion, driving the recruitment process.

• Collected data and samples by established protocols and provided the time to complete Case Report Forms, supporting data integrity and facilitating study progress. Maintained study files according to sponsor requirements and the University’s policies.

• Worked closely with the PI to create research protocol modifications, maintaining compliance with Federal regulations, including university and sponsoring agency policies and procedures.

• Coordinated with the PI to oversee the study's daily activities, address challenges, drive communications, and lead protocol management.

• Led the assessment and development of a comprehensive understanding of study protocols, study proceedings, timelines, and inclusion and exclusion criteria, including confidentiality and privacy protections, maintaining strict compliance with research standards.

Associate Professor, School of Medicine, Universidad, Dr. Jose Matias Delgado (UJMD) 2017-2018

• Participated in designing course materials, syllabi, and assessment tools to ensure the clinical research curriculum aligned with the latest advancements in the field and met the program's educational objectives.

• Supervised and directed medical students and residents interested in clinical research; coached them on research projects, study design, data collection, analysis, and manuscript writing; and provided career guidance and support to students considering a career in clinical research.

• Oversaw and mentored graduate students, research assistants, and fellows involved in clinical research projects; directed them through the research process, assisted in data analysis, and provided feedback on research proposals, manuscripts, and presentations to support their development.

• Drove research collaborations, by liaising with colleagues within and outside the School of Medicine; participated in multidisciplinary research teams, collaborated on grant proposals, and contributed to research projects addressing clinical research questions and enhancing patient care.

• Assisted with securing funding for clinical research projects by participating in grant writing activities involving research proposal development and budgeting while maintaining compliance with funding agency guidelines.

• Served on multiple committees related to curriculum development, research ethics, and faculty development. Attended faculty meetings, participated in creating strategic plans, and worked with colleagues to improve the academic environment and promote excellence in education and research.

• Kept abreast of advancements in the field and improved knowledge by attending conferences, workshops and seminars on clinical research methodologies and teaching techniques.

• Prepared lecture notes and taught courses in clinical research to medical students and other healthcare professionals; initiated classroom discussions and led practical sessions to build skills in study design, data analysis, ethical considerations, and research methodology.

Consultant, World Health Organization 2017-2018

• Established partnerships between El Salvador’s national hospitals of the second and third levels of care to collect clinical and epidemiological data on Zika virus projects.

• Collaborated with hospital administrators, healthcare providers, and research teams to develop collaboration agreements and ensure uniform data collection procedures.

• Championed the development of a national database on Zika cases in El Salvador; designed data entry protocols and data validation procedures and ensured data security and confidentiality.

• Analyzed the collected clinical and epidemiological data, interpreted the results from the analysis, and summarized the results into comprehensive and detailed reports.

• Prepared the final report on the data gathered for the investigation into the classification of Zika cases, ensuring the report included recommendations and conclusions based on the research outcomes.

• Spearheaded the establishment of research protocol on the clinical and epidemiological characterization of patients with Zika in El Salvador; designed research study, determined effective data collection methods, and defined the research objectives. Guillermo Armando Barahona Hernandez, MPH, MBA

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PROFESSIONAL WORK EXPERIENCE CONTINUED

Postdoctoral Fellowship Infectious Diseases, University of Louisville 2015-2017

• Successfully completed two Community-acquired Pneumonia studies in all nine adult acute care hospitals in Jefferson County under the mentorship of Dr. Julio Ramirez: “Streptococcus Pneumoniae Serotypes in adults 18 years and older with Radiographically Confirmed Acquired Pneumonia (UAD).” “Population-Based Study to define the clinical and economic burden of Pneumococcal Pneumonia in Hospitalized Adult Patients in Jefferson County, Kentucky (HAPPI).”

• Led a team of 15 research associates in screening patients through electronic medical records, focusing on identifying potential research subjects who exhibited radiological findings indicative of pneumonia and recording respiratory symptoms using a screening log to ensure they met the eligibility criteria.

• Selected and assigned one Research Associate to visit each of the nine hospitals of Jefferson County for enrollment and oversaw the data collection process assigned to the rest of the team.

• Built, developed, and supervised two additional teams, specifically for data quality and for informed consent auditing; supervised the teams’ operations, recording an 85% reduction in the queries identified by CCRO from Pfizer.

• Completed the two-year data collection for the HAPPI study four months before the deadline proposed by the study sponsor by building a team of the best data collectors from the research division. CLINICAL TRIALS MANAGED

Source of

funding

IRB ID NCT ID Study Title

Federally

funded

studies

NA_00077378 NCT01696747 Gastroparesis Registry 2 (GpR2): Continuation of the NIDDK Registry for the Characterization and Clinical Course of Gastroparesis Patients. IRB00188854 NCT03680859 The NIDDK Gastroparesis Registry 3 (GpR3): Characterization and Clinical Course of Symptoms and Gastric Emptying in Patients with Symptoms of Gastroparesis. IRB00201691 NCT03587142 Buspirone for Early Satiety and Symptoms of Gastroparesis: A Multicenter, Randomized, Placebo-Controlled, Double-masked Trial (BESST). 23-013033 NCT05846802 Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia.

21-001928 NCT04869670 A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis. Industry

sponsored

IRB00190328 NCT03712124 A Phase 2, Randomized, Double-Blind, Placebo-Controlled Pilot Study of CNSA- 001 in Women with Moderate to Severe Diabetic Gastroparesis. IRB00210911 NCT04028492 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy of Tradipitant in Relieving Symptoms of Gastroparesis. IRB00245377 NCT04303195 A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of NG101 Administered Orally to Patients with Gastroparesis.

IRB00204104 NCT04309396 Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities.

IRB00265410 NCT04857281 Non-invasive vagal nerve stimulation (nVNS) for symptomatic exacerbation of nausea in patients with gastroparesis and related disorders. Investigator

Initiated

IRB00247402 NCT04349891 Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders (TEA). IRB00146085 NCT04872452 Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders. IRB00268695 NCT04611958 Intraductal Liposomal Bupivacaine for Chronic Pancreatitis. IRB00184232 NCT04300127 Pioglitazone for Idiopathic Gastroparesis (PIOGAS). IRB00114555 NCT04872439 Novel Antineuronal Antibodies in Gastrointestinal Motility Disorders. IRB00087869 NCT04859829 Autoimmune Gastrointestinal Dysmotility: Symptoms, Pathogenesis and Treatment.

IRB00248899 NCT04360252 Gracie Diet for Gastroesophageal Reflux Disease. IRB00082222 NCT03035799 Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms. IRB00082222 NCT03035799 Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms. IRB00146589 NCT04880538 Enteric Neural Precursor Cells (ENPC) in the Human Gut. IRB00165256 Brain/Human Computer Interface (B/HCI) technologies for enhancing motor skills learning and rehabilitation.

IRB00179949 Compassionate single case use of autologous muscle derived cells for gastro- intestinal repair (AMDC-GIR) for the treatment of esophageal aperistalsis. IRB00181108 Identification and isolation of the human enteric neural stem cell: laying the foundation for curing achalasia.

IRB00209799 Correlation between gastrointestinal symptoms and Esophago-Gastro-Intestinal Transit Scintigraphy results.

IRB00218893 JAG-A Registry

23-002017 Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders. 23-011453 Identifying new antibodies and genotyping patients with gastrointestinal dysmotility. (GGIG study).

23-010435 Interrogating the Pathophysiology Mechanism of Constipation in Patients with Systemic Sclerosis.

23-000805 JAGA Registry Mayo Clinic

23-004127 Low-Dose Growth Hormone for the Treatment of Gastroparesis. EDUCATION

Master’s Degree, Public Health, Universidad Europa del Atlantico, Santander, Spain Master’s Degree, Palliative Care, Universidad San Jorge, Zaragoza, Spain Master’s Degree, Executive Leadership Development, Universidad de Nebrija, Madrid, Spain Master’s Degree, MBA in Healthcare Management, Cerem Business School, Universidad Rey Juan Carlos, Madrid, Spain Doctor in Medicine, Universidad de El Salvador, San Salvador, El Salvador LANGUAGES

English and Spanish

AWARD, TRAINING & CERTIFICATIONS

• Certification of Educational Commission for Foreign Medical Graduates (ECFMG) United States of America.

• Johns Hopkins Department of Medicine. W. Leigh Thompson Excellence in Research – Clinical Research Fellow Award.

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)- CITI Program.

• Human Subject Protection – CITI Program.

• Biosafety (Research Teams) – CITI Program.

• Basic Human Subjects Research – CITI Program.

• Good Clinical Practice – CITI Program.

• Basic Life Support Certified.

• Patient Privacy for Workforce Members.

• Electronic Information Security and Data Management Training Language Services for Patients, Family and Friends: Best Practices in the Use of Language Services.

• Bloodborne Pathogens.

• Clinical Research Management System (CRMS).

• Clinical Research Billing Orientation.

• Conflict of Interest and Commitment.

• HIPAA for Research Complete.

Guillermo Armando Barahona Hernadez, MPH, MBA

410-***-**** **************@*****.*** Scottsdale, AZ LinkedIn Profile PUBLICATIONS

• Non-Invasive Vagal Nerve Stimulation Reduces Nausea Rescue Medication in Patients with Gastroparesis and Related Disorders, With Additional Benefits on Multiple Other Associated Symptoms. G. Barahona, L. Villatoro, G. Treisman, M. McKnight, R. Burns, C. K. McClure, et al. Official journal of the American College of Gastroenterology ACG 2023 Vol. 118 Issue 10S Pages S1373.

• A Syndrome of Joint Hypermobility, Autonomic Dysfunction, Gastrointestinal Dysfunction and Autoimmune markers (JAG- A): Clinical Associations and Response to Intravenous Immunoglobulin Therapy. P. J. Pasricha, M. McKnight, L. Villatoro, G. Barahona, J. Brinker, K. Hui, et al. medRxiv 2023 Pages 2023.10. 01.23296388

• The Use of Post-Prandial Breath Hydrogen to Monitor Antibiotic-Induced Changes in the Activity of the Gut Microbiome G. Barahona, A. Moran, B. McBride, K. Harrison, L. Villatoro, R. Burns, et al. Official journal of the American College of Gastroenterology ACG 2022 Vol. 117 Issue 10S Pages e1122-e1123.

• Breath hydrogen responses measured by a novel portable hydrogen breath analyzer and smart phone App used at home can distinguish normal subjects from patients with suspected SIBO. Barahona G.A., Villatoro L.G., McKnight M., Burns R., Shortt C., McGovern N., Pasricha P.J., May 1, 2021. In: The American Journal of Gastroenterology. 160 (6), S-485-S-486.

• THE MORBIDITY AND MORTALITY BURDEN OF PEDIATRIC GASTROPARESIS: A NATION-WIDE ANALYSIS OF ACADEMIC MEDICAL CENTERS. B. Konings, L. V. de Barahona, G. Barahona, R. Burns, M. McKnight, B. P. Chumpitazi, et al. Gastroenterology 2023 Vol. 164 Issue 6 Pages S-948.

• Impact of COVID-19 on Motility Practices: New Onset Gastrointestinal and Autonomic Dysfunction After COVID-19 and the Effects of Vaccination in a Nationwide Cohort Study. B. Konings, L. Villatoro, G. Barahona, R. Burns, M. McKnight, K. Hui, et al. Official journal of the American College of Gastroenterology ACG 2022 Vol. 117 Issue 10S Pages e367-e368.

• Comparison of an At-Home Hydrogen Methane Breath Analysis Device With Reference Benchtop Devices. B. McBride, E. Lafferty, C. Waechter, C. Shortt, P. Harte, A. Shortt, et al. Official journal of the American College of Gastroenterology ACG 2023 Vol. 118 Issue 10S Pages S1345-S1346.

• Joint hypermobility, autonomic dysfunction, gastrointestinal dysmotility and autoimmunity (JAG-A)-Clinical associations and the response to intravenous immunoglobulin therapy. Pasricha P.J., McKnight M., Burns R., Villatoro L., Barahona G., Hui K., Bulat R., Treisman G., Yenokyan G., Aug 1, 2021. In: Neurogastroenterology and Motility. 33.

• DIFFERENCES IN THE INCIDENCE AND PREVALENCE OF GASTROPARESIS IN THE WHITE, BLACK AND HISPANIC POPULATION: AN ANALYSIS OF A NATIONWIDE DATABASE. B. Konings, L. V. de Barahona, G. Barahona, R. Burns, M. McKnight, K. Y. Hui, et al. Gastroenterology 2023 Vol. 164 Issue 6 Pages S-737.

• Stiff person syndrome is commonly associated with gastrointestinal symptoms and dysmotility. Villatoro L., Barahona G., McKnight M., Burns R., Koshorek J., Newsome S., Pasricha P.J., Aug 1, 2021. In: Neurogastroenterology and Motility. 33.

• Postprandial Breath H2 Using a Portable Handheld App-Connected Device to Predict the Presence of Small Intestinal Bacterial Overgrowth as Well as the Response to Antibiotic Treatment. Barahona G., Moran A., Bride B., Villatoro L., Burns R., Konings B., Bulat R., McKnight M., Pasricha P.J., Oct 1, 2021. In: The American Journal of Gastroenterology. 116, S632.

• Improving the Diagnosis of SIBO Using an At-Home Handheld App Connected Breath Analysis Device (AIRE). Barahona G., Mc Bride B., Moran A., Hawamdeh S., Villatoro L., Burns R., Konings B., Bulat R., McKnight M., Shortt C., Pasricha P.J., Jan 1, 2022. In: medRXiv.

• An open-label trial of the PPAR-γ Ligand pioglitazone for idiopathic gastroparesis: a first step towards disease-modifying therapy. Barahona G.A., Villatoro L.G., Konings B., Burns R., McKnight M., Bulat R.S., Pasricha P.J., May 1, 2022. In: The American Journal of Gastroenterology. 162 (7), S-394. Guillermo Armando Barahona Hernadez, MPH, MBA

410-***-**** **************@*****.*** Scottsdale, AZ LinkedIn Profile

• Differences in the epidemiology, treatment and outcomes of black patients with gastroparesis in a nationwide analysis of academic medical centers. Konings B., Villatoro L.G., Barahona G.A., Burns R., McKnight M., Potter J.J., Hui K.Y., Gayane Y., Pasricha P.J., May 1, 2022. In: The American Journal of Gastroenterology. 162 (7), S-108-S-109.

• Does prior gastrointestinal (GI) dysfunction predict the development of Parkinson's disease: testing the Braak hypothesis using a large national database. Konings B., Villatoro L.G., Van den Eynde J., Barahona G.A., Burns R., McKnight M., Hui K.Y., Pasricha P.J., May 1, 2022. In: The American Journal of Gastroenterology. 162 (7), S-196- S197.

• Gastrointestinal syndromes preceding a diagnosis of Parkinson’s disease: testing Braak’s hypothesis using a nationwide database for comparison with Alzheimer’s disease and cerebrovascular diseases. B. Konings, L. Villatoro, J. Van den Eynde, G. Barahona, R. Burns, M. McKnight, et al. Gut 2023 Vol. 72 Issue 11 Pages 2103-2111.

• Impact of the Episod trial on practice: A retrospective study using a nationwide electronic health record network. Konings B., Villatoro L.G., Barahona G.A., Burns R., McKnight M., Hui K.Y., Pasricha P.J., June 1, 2022. In: Gastrointestinal Endoscopy. 95 (6), AB324.

POSTER PRESENTATIONS

• The Impact of Prior Antibiotic Therapy on the Clinical Outcomes of patients admitted in the hospital for Community Acquired Pneumonia. Barahona, G.A. & Reyes, A. A., & Arnouk, J.A. (September 2015). Poster presented at: Research Louisville; Louisville, KY, USA.

• Correlation of procalcitonin levels with severity of disease in hospitalized patients with CAP Arnouk, J. & Booja, H. & Murtaza, A. & Barahona, G. A. & Srinivasan, K. (September 2015). Poster presented at: Research Louisville; Louisville, KY, USA.

• Cardiovascular events associated with Pneumococcal Pneumonia versus Influenza Gonzalez, J. & Barahona G. A. & Reyes E. Medina M. (September 2015). Poster presented at: Research Louisville; Louisville, KY, USA.

• Incidence and clinical outcomes of hospitalized patients with viral community acquired pneumonia (CAP) in Louisville, KY: Results from the University of Louisville Pneumonia Study. Villatoro, L. & Barahona, G. & Abaid, B. & Pattampalli, S. & Ramachandruni, S & Persaud, A & Ramirez, J. (October, 2016). Poster presented at: Research Louisville; Louisville, KY, USA.

• Do antiplatelet medications prevent poor clinical outcomes in patients with CAP. Martell, C. & Barahona, G. A. & Baires, J. & SirDeshpande, P. & Uranga, A. (September 2015). Poster presented at: Research Louisville; Louisville KY, USA

• Isolation of two organisms in hospitalizations due to CAP in Louisville, KY: is this true co-infection? Barahona, G.A. & Villatoro, L.G. & Ramachandruni, S & Burns, M. & Martell, C.A. & Fernandez, F. (October 2016). Poster presented at: Research Louisville; Louisville, KY, USA.

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