Icahn School of Medicine – Mount Sinai Health System
Mineola,USA
3
Languages
1
Certification
13
years of professional experience
Results-driven Clinical Research Coordinator II with over 5 years of extensive clinical trial experience managing multiple concurrent studies in cardiology, nephrology, and autoimmune diseases at academic medical centers, including Mount Sinai and Columbia University Irving Medical Center. Dedicated to driving innovation and improving patient outcomes through research methodologies. Known for fostering team collaboration and adapting to evolving project needs, while excelling in data management and regulatory adherence. Coauthor of 7 peer-reviewed publications, demonstrating a strong commitment to advancing clinical research operations and contributing to the scientific community.
Work History
Clinical Research Coordinator II
2 Years
Icahn School of Medicine – Mount Sinai Health System | 08.2024 - Current
Manage concurrent Phase-II interventional trials across autoimmune disease (SLE, IIM, SSc, IgA nephropathy) in full compliance with ICH-GCP, FDA, and institutional guidelines.
Conduct all study visit procedures including informed consent, protocol-driven assessments, clinical evaluations, and realtime source documentation for enrolled participants.
Monitored data collection for accuracy, ensuring timely reporting of adverse events to regulatory bodies.
Served as primary site liaison for sponsors, CROs, and CRAs; coordinated monitoring visits (SIVs, IMVs, RMVs) and resolved findings within required timelines.
Proactively identify protocol deviations and enrollment barriers; implement CAPA in collaboration with investigators, reducing deviation recurrence.
Managed patient recruitment and retention strategies to enhance study participation rates.
Developed site level workflows to enhance operational efficiency; trained and mentored junior research staff on GCP standards and data quality practices.
Clinical Research Assistant / Regulatory Assistant
1 Year 9 Months
Columbia University Medical Center | 11.2022 - 08.2024
Facilitated efficient organization of study-related documents through meticulous record-keeping practices.
Monitored and maintained regulatory documents to ensure patient safety and compliance with sponsors and IRB.
Coordinated annual sponsor monitoring visits and resolved data queries within established timelines to support trial integrity.
Processed and shipped biological specimens for protocols, ensuring compliance with laboratory and regulatory requirements.
Led initiatives to improve documentation processes, increasing operational efficiency across multiple research projects.
Co-authored 7 peer-reviewed publications in high-impact cardiology journals as part of the ATTR-CM and cardiac amyloidosis research program.
Clinical Assistant
1 Year 1 Month
Essen Health Care | 10.2021 - 11.2022
Monitored and documented vital signs patients daily, ensuring accurate EMR records to support effective patient management.
Assisted in patient intake and medical history documentation.
Conducted diagnostic testing and assisted in clinical evaluations to support timely treatment decisions.
Coordinated communication between patients and healthcare providers to enhance care delivery.
Medical Assistant
5 Months
Gayatri Devi MD PC – Neurology Practice | 04.2021 - 09.2021
Conducted transcranial magnetic stimulation (TMS) sessions and EEG testing, aiding in accurate neurological diagnosis and effective treatment monitoring.
Documented comprehensive patient histories and vital signs, processed billing, and resolved reimbursement discrepancies to ensure seamless patient care.
Assisted in patient intake, ensuring accurate documentation of medical histories and current medications.
Coordinated patient appointments, optimizing scheduling for maximum efficiency and minimal wait times.
Prepared examination rooms, maintaining cleanliness and readiness for physician visits to enhance patient experience.
Medical Officer (Physician – Licensed Equivalent, Dominican Republic)
6 Years 11 Months
Air Force of the Dominican Republic | 02.2014 - 01.2021
Delivered comprehensive primary and urgent care to active-duty personnel, conducting full patient evaluations through diagnostic testing, laboratory review, and imaging interpretation to ensure accurate diagnoses.
Developed and implemented individualized pharmacologic and non-pharmacologic treatment plans in collaboration with supervising physicians, enhancing patient care across outpatient and hospital settings.
Coordinated triage communications, specialist referrals, and prescription authorizations for active-duty patients, streamlining patient access to necessary medical services.
Education
Doctor of Medicine - Medicine
Universidad Iberoamericana (UNIBE) | Santo Domingo, Dominican Republic | 07-2018
Graduated: July 2018
Honoree of Cum Laude
Skills
ICH-GCP & FDA Regulatory Compliance
Safety reporting
EDC Management (Medidata Rave)
Monitoring Visit Support (SIV / IMV / RMV)
Protocol Deviation & CAPA Management
Regulatory Binder & TMF Maintenance
HIPAA Compliance
Florence eISF & CTMS
REDcap
EMR
SELECTED RESEARCH PUBLICATIONS
Quantitative Uptake of 124I-Evuzamitide on PET Correlates with Markers of Transthyretin Cardiac Amyloidosis, Quality of Life, and Functional Status. Smiley DA, Einstein AJ, ... Collado KM, et al.
Detection of Transthyretin Cardiac Amyloidosis Using 124I-Evuzamitide: A Pilot PET/CT Study. Smiley DA, Einstein AJ, ... Mateo KA, et al. Columbia University Irving Medical Center / New York-Presbyterian Hospital.
Left Atrial Dyssynchrony During Sinus Rhythm: A Predictor for Incident Atrial Fibrillation/Flutter in Transthyretin Cardiac Amyloidosis. Chan N, Smiley DA, ... Mateo Collado KA, et al.
Sodium-Glucose Cotransporter-2 Inhibitor Therapy and Body Composition in Transthyretin Amyloid Cardiomyopathy: A Prospective Pilot Study. Nalbandian A, Teruya SL, ... Mateo Collado K, et al.
+ 3 additional publications available upon request.
Certification
Good Clinical Practice (GCP) – ICH Focus
GCP for Clinical Trials with Investigational Drugs and Biologics
Data Security & HIPAA Training
Financial Conflicts of Interest in Research
Florence eISF Training for Study Staff
+ 6 additional certifications available upon request.
LANGUAGES
English – Native/Bilingual
Native or Bilingual
Spanish – Native/Bilingual
Native or Bilingual
French – Limited Working Proficiency
Limited Working
Interests
Playing Sports
Swimming
Backpacking and Hiking
Volunteer Work
Timeline
Clinical Research Coordinator II
Icahn School of Medicine – Mount Sinai Health System
08.2024 - CurrentRead More
Clinical Research Assistant / Regulatory Assistant
Columbia University Medical Center
11.2022 - 08.2024Read More
Clinical Assistant
Essen Health Care
10.2021 - 11.2022Read More
Medical Assistant
Gayatri Devi MD PC – Neurology Practice
04.2021 - 09.2021Read More
Medical Officer (Physician – Licensed Equivalent, Dominican Republic)
Clinical Research Associate II – Site Management & Clinical Trial Operations at ICON PLCClinical Research Associate II – Site Management & Clinical Trial Operations at ICON PLC