Miriam Rodriguez
Weehawken
Summary
Dynamic Clinical Operations and Medical Device Specialist with a strong focus on cardiothoracic organ preservation. Proven track record in supporting clinical research protocols, evaluating device performance, and ensuring regulatory compliance in high-acuity environments. Adept at collaborating with multidisciplinary teams to enhance operational efficiency and improve patient outcomes. Committed to leveraging expertise to drive innovation.
Overview
7
7
years of professional experience
Work History
Senior Clinical Operations Specialist
TransMedics
Teterboro, NJ
03.2024 - Current
- Led clinical operations and field support for the TransMedics Organ Care System (OCS) across heart, lung, and liver transplant programs.
- Executed heart transplant procurement missions, supporting and collaborating with surgeons,coordinators and perfusionists.
- Operated and managed ex-vivo heart perfusion technology.
- Monitored and interpreted perfusion parameters and device performance to optimize heart viability prior to recipient transplantation.
- Contributed to clinical evidence generation and quality improvement initiatives through detailed reporting and outcomes tracking.
- Conducted regular audits and assessments to guarantee compliance with FDA regulations, GCP standards, and institutional protocols.
- Coordinated site onboarding, clinical training, and technology integration as part of new program implementation initiatives.
Emergency Department Registered Nurse
Nightingale Nurses
Englewood, NJ
12.2021 - 03.2024
- Delivered high-acuity care in fast-paced emergency settings managing trauma and critically ill patients
- Demonstrated strong clinical judgment in high-pressure, time-sensitive environments
- Collaborated across multidisciplinary teams to improve patient outcomes and operational efficiency
- Maintained compliance with clinical documentation standards, regulatory requirements, and patient safety protocols
- Participated in clinical research support activities, including protocol adherence and coordination with care teams
Emergency Department Registered Nurse
Hackensack University Medical Center
Hackensack, NJ
06.2021 - 12.2021
- Delivered high-acuity care in fast-paced emergency settings managing trauma and critically ill patients
- Demonstrated strong clinical judgment in high-pressure, time-sensitive environments
- Collaborated across multidisciplinary teams to improve patient outcomes and operational efficiency
- Maintained compliance with clinical documentation standards, regulatory requirements, and patient safety protocols
- Participated in clinical research support activities, including protocol adherence and coordination with care teams
Emergency Department Registered Nurse
Hackensack Meridian Health
Perth Amboy, NJ
10.2019 - 06.2021
- Delivered high-acuity care in fast-paced emergency settings managing trauma and critically ill patients
- Demonstrated strong clinical judgment in high-pressure, time-sensitive environments
- Collaborated across multidisciplinary teams to improve patient outcomes and operational efficiency
- Maintained compliance with clinical documentation standards, regulatory requirements, and patient safety protocols
- Participated in clinical research support activities, including protocol adherence and coordination with care teams
Education
Bachelor of Arts - Psychology
Kean University
Union, NJ05.2012
Bachelor of Science - Nursing
Chamberlain College of Nursing
North Brunswick, NJ01.2023
Associate of Science - Nursing
JFK Muhlenberg Harold B. & Dorothy A. Snyder Schools
Plainfield, NJ06.2020
Skills
- Clinical Affairs: Experience in supporting clinical research protocols, device performance evaluation, and regulatory-compliant clinical operations in high-acuity environments
- Medical Device Clinical Support: Advanced expertise with TransMedics Organ Care System (OCS) for heart, lung, and liver transplantation including device setup, troubleshooting, and intraoperative monitoring
- Device Performance Monitoring & Evaluation: Monitoring and interpreting perfusion parameters and device performance data to optimize organ viability and transplant outcomes
- Regulatory Compliance: Ensuring compliance with FDA regulations, Good Clinical Practice (GCP) standards, and institutional protocols
- Organ Transplant Logistics & Clinical Operations: Led clinical operations and field support for organ transplant programs and executed organ procurement missions with medical device deployment and clinical protocol adherence
- Cross-Functional Clinical Collaboration: Collaborated with transplant surgeons, perfusionists, Organ Procurement Organization (OPO) teams, and multidisciplinary teams to ensure protocol-driven execution of complex procedures and improve patient outcomes
- Clinical Data Reporting & Outcomes Analysis: Contributed to clinical evidence generation and quality improvement initiatives through detailed reporting and outcomes tracking
- Program Implementation & Site Training: Supported new program implementations including site onboarding, clinical training, and technology integration
Timeline
Senior Clinical Operations Specialist
TransMedics
03.2024 - Current
Emergency Department Registered Nurse
Nightingale Nurses
12.2021 - 03.2024
Emergency Department Registered Nurse
Hackensack University Medical Center
06.2021 - 12.2021
Emergency Department Registered Nurse
Hackensack Meridian Health
10.2019 - 06.2021
Bachelor of Arts - Psychology
Kean University
Bachelor of Science - Nursing
Chamberlain College of Nursing
Associate of Science - Nursing
JFK Muhlenberg Harold B. & Dorothy A. Snyder Schools