MICHELLE L. MENDIOLAZA
New York,NY
Summary
Highly skilled and enthusiastic professional with experience managing operations in patient-centric medical offices. Successfully oversee various human research studies, budgeting, supply management, and patient services. Develop and lead productive and efficient office staff. Contribute to high-volume medical practices by providing exceptional customer service.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Program Manager I
Institutes for Translational Sciences at Mount Sinai
06.2022 - Current
- Responsible for the development and delivery of comprehensive training and educational content for clinical research trainees and faculty (in-person and virtually); supervises new hires on the effective use of internal research systems to ensure a smooth onboarding process; develops departmental standard operating procedures (SOPs) and job aids to improve workflows; serves as a liaison and represents the Office of Research Services (ORS) to administrators, leaders, and staff in other departments; implements new programs, such as New Research Faculty and New Clinical Research Coordinator Orientations for MSHS; creates program newsletters and announcements for distribution via research listservs; manages institutional research queries and performs issue resolutions through JIRA Software; uses REDCap for building and managing needs assessments
- Project Management: facilitates coordination of ongoing quantitative and qualitative projects (e.g., agendas, goal metrics, spreadsheets), defines project tasks, delegates staff, and provides technical advice to resolve problems toward project milestones; cleans and statistically analyzes clinical data; ensures the prompt submission of Institutional Review Board (IRB) documents for internal projects; and remains informed of changing regulations which may affect project objectives
- Aids in the submission of NIH/NCATS applications for UL1, KL2, and similar pilot studies; provides direction to investigators regarding tactical and time-sensitive submission of regulatory (e.g
- Other Support) documents.
Clinical Research Coordinator II
Pediatric Clinical Trials Office (PCTO) at Mount Sinai
07.2021 - 06.2022
- Under the Department of Pediatrics, concurrently supported both the PCTO and Inflammatory Bowel Disease Center by managing and monitoring all aspects of IBD-related projects and pediatric clinical trials (Phase II-IV)
- Managed subject screening and recruitment using various tools in EPIC
- Assisted with Industry Collaborations, Clinical Trial Feasibility, Site Selection, and Site Initiation Visits
- Maintained strategic relationships with stakeholders inside and outside the health system (e.g
- Physicians, cross-functional partners, payers, suppliers)
- Prepared the site for regulatory inspections and audits; identified compliance issues and verified that all regulatory procedures were documented and communicated to the study team and sponsor
- Ensured execution of Clinical Trial Agreements, oversaw updates to relevant source systems (e.g
- Milestone tracking, enrolment status), and handled archiving of essential documentation in Central Document Repositories
- Provided Sponsor with updates regarding subject enrollment, milestone payments, and approved invoices per contract; managed monitoring visits (remote and in-person); directed clinical assessments and evaluation of subjects following administration of intervention; worked with and oversaw vendors and Contract Research Organizations (CRO) on clinical trials; maintained Paper and Electronic Trial Master File (eTMF), Electronic Data Capture (EDC) systems, reporting of Adverse Events, and quality control (QC) testing activities
- Served as the liaison to industry, vendors, and institutional offices.
Clinical Research Coordinator II
The Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai
12.2019 - 06.2022
- Under the Department of Pediatrics, supported the IBD Center by analyzing complex clinical data for quantitative and qualitative projects, handled data entry management, and ensured research protocols were submitted and renewed in a timely and efficient manner
- Submitted human subjects’ research applications to the IRB, Grants Office, and related departments; ensured that all institutional and external regulatory requirements were addressed for various clinical research projects
- Trained less experienced research staff on screening and recruitment methods, quality standards, institutional procedures, and ICH/GCP regulations for investigational/biologic agents; developed SOPs to improve research operations and workflows; assisted with the preparation of new IRB protocols, protocol amendments, and renewals of ongoing studies by working with internal and external IRBs; handled specimen collections, processing, and shipment for industry-funded clinical trials; and assisted with expansive REDCap database enhancements
- Expertise with institutional systems: EPIC, IRB, Grants Office (InfoEd), MSIP, Sinai Central, PEAK, CITI Program and external systems: Advarra, WIRB, DrugDev, Covance, Veeva, Medrio, Medidata/RAVE, and InForm.
Program Coordinator I
The Graduate School of Biomedical Sciences at Mount Sinai
04.2019 - 12.2019
- Under the Clinical Research Education (CLR) Program, developed project timelines related to student milestones, tracked progress of current graduate students, and conducted weekly information sessions about the program online
- Maintained programming activities, including space allocations and program events, and created program evaluation surveys using RedCap and Formstack
- Prepared program orientation materials; provided resources for students seeking academic or disability support services; collaborated internally with central admissions, the Office of Enrollment Services, the Deans’ offices, and other ISMMS departments; represented the program at national conferences; and trained and delegated tasks to the Administrative Assistant.
Graduate Student Intern
The Graduate School of Biomedical Sciences at Mount Sinai
12.2018 - 04.2019
- Under the direction of the Clinical Research Education (CLR) Program, provided administrative and logistical support; spoke with and provided guidance to prospective applicants; monitored, and screened graduate school applications
- Worked directly with the program Associate Director on marketing material, assisted with program information sessions, answered program phone calls, responded to program emails, compiled, and tabulated student data, and performed other administrative duties assigned.
Undergraduate Advocate & Triage Coordinator
Health Leads Program at Woodhull Medical Center
09.2015 - 05.2017
- Maintained a caseload of 6-10 patients per week
- Advocated for patients in English and Spanish, liaising with various departments and outside agencies
- Translated messages for medical staff and maintained confidentiality of patient documents (HIPAA trained)
- As Triage Coordinator, managed the patient database (REACH), trained new advocates on screening protocol to obtain demographic information from patients, and managed a Triage Team to improve patient enrollment rates and to monitor REACH.
Student Laboratory Worker
NYU College Core Curriculum at the NYU Silver Building
02.2014 - 10.2016
- Set up and removed equipment for labs, followed oral and written protocol instructions, handled toxic waste and chemicals, reported and stocked inventory of research supplies, performed washes and sterilization of lab equipment, transported documents and lab tools, and maintained lab documentation.
Summer Fellow
Health Leads Program at Woodhull Medical Center
05.2015 - 08.2015
- Maintained a caseload of 15-18 patients per week and connected disadvantaged families to public resources such as summer camps, exercise programs, academic enrichment programs, medical and dental insurance, and legal assistance
- Discussed patient cases with Program Manager and summer fellows, listened to healthcare professional guest-speakers, and presented a quality improvement summer project.
Education
Doctor of Philosophy (Ph.D.) - Clinical Research
Icahn School of Medicine At Mount Sinai
New York, NY05.2025
Master of Science (M.S.) - Clinical Research
Icahn School of Medicine at Mount Sinai
New York, NY06.2019
Certificate - Clinical Research
Icahn School of Medicine at Mount Sinai
New York, NY06.2018
Bachelor of Arts (B.A.) - Chemistry
New York University
New York, NY05.2017
Skills
- Combined 10 years of expertise in Clinical Research
- 4 years of ensuring regulatory compliance, operational management, and analyses of human subject studies: internal studies and multi-site industry-funded clinical trials
- 6-year educational background focusing on research design, ethical guidelines, biostatistical analyses, and study management
- Highly skilled in SAS and R for clinical data analyses, visualization, and cleaning
- Strong expertise using REDCap for instrument development and highly experienced with mixed-methods research and MAXQDA software
- Strong proficiency in evaluating manuscript coherence through journal peer review processes and providing editorial guidance
- Proficient in various professional tools: Outlook, Microsoft Word, Excel, PowerPoint, SharePoint, MS Teams, Zoom, and Slack
Peer Review Experience
- Inflammatory Bowel Diseases, Our life is a roller-coaster! A qualitative phenomenological study exploring the impact of IBD on family members, Reviewer, 12/2023
- Patient Preference and Adherence, A Systematic Review of Quality of Life in Patients with Short Bowel Syndrome and Their Caregivers, Reviewer, 12/2023
- Patient Preference and Adherence, Experience of Disease Acceptance in Chinese Patients with Newly Diagnosed Crohn's Disease: A Descriptive Qualitative Study, Reviewer, 08/2023
- Journal of Inflammation Research, Identification of Targets for Subsequent Treatment of Crohn's Disease Patients After Failure of Anti- TNF Therapy, Reviewer, 07/2023
- Psychology Research and Behavior Management, A qualitative analysis of stress experiences and coping strategies in adolescents with Crohn’s disease, Reviewer, 07/2023
Teaching Assistant Experience
- PhD Year 1, Spring 2, CLR 207, Culture, Illness, and Community Health, Dr. Gallane Abraham, Dr. Georgina Osorio
- PhD Year 2, Spring 1, MPH 812, Applied Linear Models I, Dr. John Doucette
- PhD Year 2, Spring 2, CLR 207, Culture, Illness, and Community Health, Dr. Gallane Abraham, Dr. Georgina Osorio
- PhD Year 3, Fall, MPH 300, Introduction to Biostatistics, Dr. John Doucette
- PhD Year 3, Spring 1, MPH 812, Applied Linear Models I, Dr. John Doucette
- PhD Year 4, Fall, MPH 300, Introduction to Biostatistics, Dr. John Doucette
- PhD Year 4, Spring 1, MPH 812, Applied Linear Models I, Dr. John Doucette
- PhD Year 4, Spring 2, MPH 822, Applied Linear Models II, Dr. Elena Colicino
- PhD Year 5, Fall, MPH 300, Introduction to Biostatistics, Dr. John Doucette
- PhD Year 5, Spring 1, MPH 812, Applied Linear Model I, Dr. John Doucette
Master Thesis
Treatment of Gastrointestinal Perforations and Leaks using Endoscopic Vacuum Therapy: A Systematic Review, Icahn School of Medicine at Mount Sinai, Ann Arbor, MI, 2019, https://www.proquest.com/docview/2240033865?pq-origsite=gscholar
Honors Awards
- ISMMS Graduate Student Travel Award
- Full Graduate Student Travel Award incl. Transportation & Housing
- Mount Sinai Innovation Partners (MSIP) Fellows Scholar
- Recipient of TL1 Fellows Award for Clinical and Translational Research
- Excellence in Leadership and Service Award in the Clinical Research Education Program
- NYU Opportunity Program: Dr. Bernadette W. Penceal Legacy Award
- NYU LatinX Distinguished Student Award
- NYU President’s Service Award
- Kaplan Scholarship
- CSTEP Sagamore Statewide Research Conference Medal
- Perry McDonough Collins Scholarship
Publications
- Transitions from pediatric to adult IBD care: Incorporating lessons from psychogastroenterology, Mendiolaza ML, Feingold JH, Kaye-Kauderer HP, Dubinsky MC, Gorbenko KO, Keefer LA, Front. Gastroenterol., 1, 1037421, 09/2022, 10.3389/fgstr.2022.1037421, https://www.frontiersin.org/articles/10.3389/fgstr.2022.1037421/full?utm_source=F-NTF&utm_medium=EMLX&utm_campaign=PRD_FEOPS_20170000_ARTICLE
- Dashboard-Driven Accelerated Infliximab Induction Dosing Increases Infliximab Durability and Reduces Immunogenicity, Dubinsky MC, Mendiolaza ML, Phan BL, Moran HR, Tse SS, Mould DR, Inflammatory Bowel Dis., 28, 9, 1375-1385, 09/2022, 10.1093/ibd/izab285
- Serologic Response to Messenger RNA Coronavirus Disease 2019 Vaccines in Inflammatory Bowel Disease Patients Receiving Biologic Therapies, Wong SY, Dixon R, Martinez Pazos V, Gnjatic S, Colombel JF, Cadwell K, Mendiolaza M, Gastroenterology, 161, 2, 715-718.e4, 08/2021, 10.1053/j.gastro.2021.04.025
- Empowered transitions: Understanding the experience of transitioning from pediatric to adult care among adolescents with inflammatory bowel disease and their parents using photovoice, Feingold JH, Kaye-Kauderer H, Mendiolaza M, Dubinsky MC, Keefer L, Gorbenko K, J Psychosom Res., 143, 110400, 04/2021, 10.1016/j.jpsychores.2021.110400
- Self-Reported Health and Preferences for Disclosure of Medical Information (SA527C), Kazi S, Kelley A, Boutin C, Nagpal N, Mendiolaza M, Journal of Pain and Symptom Management, 51, 2, 399, 2016, 10.1016/j.jpainsymman.2015.12.288
Affiliations
- Teaching Assistant
Certification
Awards 1
Awards 2
Awards 3
References
References available upon request.
Timeline
Program Manager I
Institutes for Translational Sciences at Mount Sinai
06.2022 - Current
Clinical Research Coordinator II
Pediatric Clinical Trials Office (PCTO) at Mount Sinai
07.2021 - 06.2022
Clinical Research Coordinator II
The Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai
12.2019 - 06.2022
Program Coordinator I
The Graduate School of Biomedical Sciences at Mount Sinai
04.2019 - 12.2019
Graduate Student Intern
The Graduate School of Biomedical Sciences at Mount Sinai
12.2018 - 04.2019
Undergraduate Advocate & Triage Coordinator
Health Leads Program at Woodhull Medical Center
09.2015 - 05.2017
Summer Fellow
Health Leads Program at Woodhull Medical Center
05.2015 - 08.2015
Student Laboratory Worker
NYU College Core Curriculum at the NYU Silver Building
02.2014 - 10.2016
Doctor of Philosophy (Ph.D.) - Clinical Research
Icahn School of Medicine At Mount Sinai
Master of Science (M.S.) - Clinical Research
Icahn School of Medicine at Mount Sinai
Certificate - Clinical Research
Icahn School of Medicine at Mount Sinai
Bachelor of Arts (B.A.) - Chemistry
New York University
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