Jessenia Lopez
Summary
Nearly 10 years of research experience, including over 5 years in clinical trials. Expertise in protocol adherence, recruitment, and data collection. Proven ability to manage interns and volunteers while ensuring quality and compliance. Strong communication skills and adaptability to changing priorities.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Research Manager
Mount Sinai Hospital
New York, New York
07.2024 - Current
- Managed operational and regulatory oversight for multiple active clinical trials, including NIH-funded studies.
- Ensured compliance with FDA regulations, ICH-GCP guidelines, and institutional policies.
- Led preparation for internal audits, sponsor monitoring visits, and regulatory inspections.
- Coordinated with research teams to facilitate efficient study operations and monitor participant recruitment.
- Developed training materials for clinical research staff on GCPs and relevant ethical guidelines.
- Provided leadership and supervision to clinical research coordinators and assistants.
- Directed study start-up activities, including feasibility reviews and IRB submissions.
- Evaluated compliance with ethical guidelines throughout all research studies.
Clinical Research Coordinator
Mount Sinai Hospital
New York, New York
07.2022 - 06.2024
- Led participant screening, enrollment, and retention efforts across multiple clinical trials, ensuring protocol adherence and high-quality informed consent processes.
- Built and managed REDCap databases to support accurate, compliant data capture and maintain data integrity throughout the study lifecycle.
- Coordinated clinical trial operations and specimen handling between clinical and laboratory teams, ensuring compliance with GCP, IRB, and biosafety requirements.
- Partnered with Principal Investigators and cross-functional teams to execute study activities, support regulatory compliance, and maintain effective communication with research participants.
- Oversaw data quality and mentored junior research staff on clinical protocols, regulatory standards, and best practices.
Clinical Research Coordinator
Vireo Health
Queens, New York
06.2021 - 04.2022
- Managed participant recruitment and maintained accurate enrollment records.
- Coordinated clinical trial activities and ensured compliance with regulatory requirements.
- Scheduled participant visits and ensured timely data collection from trials.
- Assisted in preparing regulatory documents and submissions to ethics committees.
- Maintained study databases and ensured data integrity throughout the research process.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Reviewed CRFs for completeness and accuracy before database entry.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
Study Coordinator
Albert Einstein College of Medicine
The Bronx, New York
05.2018 - 06.2021
- Screen, schedule, and enroll participants into a genetic clinical research study.
- Conducting harmonized surveys on parents of children enrolled in both English and Spanish
- Design, maintain, and organize study documentation as per IRB protocols.
Education
Master of Science - Interdisciplinary And Physical Sciences
Touro College of Osteopathic Medicine
Middletown, NY05-2018
Bachelor of Science - Biology
City College At CUNY
New York, NY06-2016
Skills
- Clinical trial management
- Regulatory compliance
- Data integrity management
- Training development
- Patient recruitment
- Ethical guidelines adherence
- Leadership skills
- Time management
- Attention to detail
- Audit preparation
- Project coordination
- Cross-functional collaboration
- Mentorship capabilities
- CCPRS Clinical Research Management certified
- Microsoft office
- MS office
- Bilingual Spanish and English
- GCP training
- Site monitoring
Languages
Spanish
Native/ Bilingual
Certification
CCRPS Advanced Clinical Research Project Manager Certification (ACRPMC), Received 2025
Publications
Odgis, J. A., Gallagher, K. M., Suckiel, S. A., Donohue, K. E., Ramos, M. A., Kelly, N. R., Bertier, G., Blackburn, C., Brown, K., Fielding, L., Lopez, J., Aguiniga, K. L., Maria, E., Rodriguez, J. E., Sebastin, M., Teitelman, N., Watnick, D., Yelton, N. M., Abhyankar, A., . . . Kenny, E. E. (2021). The NYCKidSeq project: study protocol for a randomized controlled trial incorporating genomics into the clinical care of diverse New York City children. Trials, 22(1), 146. https://doi.org/10.1186/s13063-020-04953-4
Sebastin, M., Odgis, J. A., Suckiel, S. A., Bonini, K. E., Di Biase, M., Brown, K., Marathe, P., Kelly, N. R., Ramos, M. A., Rodriguez, J. E., Aguiñiga, K. L., Lopez, J., Maria, E., Rodriguez, M. A., Yelton, N. M., Cunningham-Rundles, C., Gallagher, K., McDonald, T. V., McGoldrick, P. E., . . . Wasserstein, M. P. (2023). The TeleKidSeq pilot study: incorporating telehealth into clinical care of children from diverse backgrounds undergoing whole genome sequencing. Pilot and Feasibility Studies, 9(1), 47. https://doi.org/10.1186/s40814-023-01259-5
Timeline
Clinical Research Manager
Mount Sinai Hospital
07.2024 - Current
Clinical Research Coordinator
Mount Sinai Hospital
07.2022 - 06.2024
Clinical Research Coordinator
Vireo Health
06.2021 - 04.2022
Study Coordinator
Albert Einstein College of Medicine
05.2018 - 06.2021
Master of Science - Interdisciplinary And Physical Sciences
Touro College of Osteopathic Medicine
Bachelor of Science - Biology
City College At CUNY