Accomplished Clinical Research Manager with over 6 years in clinical trial management and regulatory compliance. Led teams to improve patient recruitment strategies and ensure quality assurance. Developed consent forms and streamlined stakeholder communication to achieve successful research outcomes.
Overview
13
13
years of professional experience
3
3
Certifications
Work History
Clinical Research Manager 2
Stanford School of Medicine-Cardiothoracic Surgery
Stanford, CA
09.2019 - Current
Managed clinical research operations, ensuring compliance with quality management standards and regulations to support trial integrity.
Provided leadership and oversight for large and small clinical research projects.
Supervised clinical research staff, promoting collaboration to improve team effectiveness and project outcomes.
Hired, oriented, trained, and conducted performance reviews for research administration staff.
Monitored staffing levels to ensure adequate coverage for trial workloads across study coordinators.
Educated research staff on established policies, processes, and procedures.
Developed consent forms for approval by Human Subjects Panel and coordinated protocol submissions to Institutional Review Board.
Prepared annual reports for regulatory agencies and conducted audits to confirm compliance with applicable regulations, maintaining research integrity.
Senior Clinical Research Coordinator
Stanford School of Medicine-Cardiothoracic Surgery
Stanford, CA
01.2016 - 09.2019
Achieved enrollment targets by overseeing subject recruitment for 12 clinical trials.
Developed strategies that increased research participation and enhanced long-term retention rates.
Managed data collection and reporting for research projects, enhancing accuracy and reliability of findings.
Collaborated with investigators to monitor adverse events and address study-related queries.
Created systems for data organization and analysis, enabling actionable insights extraction from research outcomes.
Produced educational materials on clinical trials, improving understanding for patients and healthcare professionals.
Facilitated team communication by leading meetings, preparing agendas, and distributing minutes to ensure alignment.
Clinical Research Coordinator/ Clinical Administrative Associate
Stanford School of Medicine-Cardiothoracic Surgery
Stanford, CA
10.2014 - 01.2016
Oversaw subject recruitment, successfully meeting study enrollment goals.
Collaborate with Principal Investigators to ensure serious adverse events are reported promptly.
Worked with Institutional Review Board (IRB) on amendments and investigator compliance.
Monitored data entered to ensure accuracy.
Maintains REDCap database and Human Biorepository Tissue Bank Study.
Developed project schedules and targets to minimize protocol deviations.
Developed and followed protocol budgets along with department expenses.
Provide assistance to PA-C with research study documentation and protocols.
Provided administrative support for Chair of Cardiothoracic Surgery, improving operational workflows.
Coordinated logistics for meetings, conferences, and teleconferences to ensure effective communication.
Coordinated domestic and international travel arrangements, including flight bookings and hotel reservations.
Prepare itineraries and reconcile travel expenses in a timely manner.
Licensed Vocational Nurse/CRC
Pacific Brain & Spine Medical Group
San Ramon, CA
11.2012 - 10.2014
Assisted neurosurgeons with daily operations, facilitating patient visit purposes and executing medical procedures.
Monitored study participants for side effects and healing progress, contributing to trial integrity and patient safety.
Obtained informed consent from patients for clinical trial participation, ensuring adherence to ethical standards.
Screened subjects for eligibility based on protocol-specific criteria, documenting potential participant status.
Ensured accurate and timely data collection, documentation, entry, and reporting.
Collaborated with IRB on protocol submissions, renewals, and amendments to maintain compliance with regulatory requirements.
Worked with principal investigator to address serious adverse events and resolve study queries.
Coordinated laboratory specimen collection for research studies, adhering to protocol guidelines to support accurate data acquisition.
Licensed Vocational Nurse/CRC
Dr. Patrick Bitter JR. MD
Saratoga, CA
11.2012 - 10.2014
Facilitated patient consent and recruited participants for facial rejuvenation trials to enhance research outcomes.
Evaluated clinical patient data to support informed decision-making.
Assisted physician with medical procedures, including Botox and dermal fillers.
Managed laboratory specimens, ensuring compliance with protocols to support accurate diagnostic processes.
Obtained and processed specimens for timely shipment to lab centers.
Managed incoming phone calls to ensure effective communication with patients. and submitted insurance claims to streamline patient scheduling.
Education
Licensed Vocational Nurse - Advanced Research Laboratory in Experimental Biology, Molecular and Cellular Immunology, Translational Immunology, Introduction to Laboratory Research in Cell and Molecular Biology, Cell Biology and Animal Physiology, Tumor Immunology
Unitek College
Fremont, CA
10.2010
Associates Degree A.S. -
DeAnza College
Cupertino, CA
06.2013
Skills
Microsoft Office suite
Clinical trial management
Regulatory compliance
Data management
Quality assurance
Consent form development
Team leadership
Research protocol oversight
Training and onboarding
Patient recruitment strategy
Risk management
Effective communication
GCP training
Epic EHR system
REDCap database
Conflict resolution
Clinical data management
Adverse event reporting
Site monitoring
Research tracking
Stakeholder communication
Clinical monitoring
Compliance review
Audit preparation
Budget control
Medical terminology
Patient care coordination
Discharge coordination
Blood transfusion administration
Triage assessment
Patient education
Compassionate care
Medication administration
Healthcare ethics
Nursing staff leadership
Patient advocacy
Community health
Direct nursing care
Outpatient care
Clinical documentation
Advanced cardiac life support
Surgical care
Affiliations
Research Staff COS Steering Committee, 2025
Stanford Policies and Procedures Working Group, 2023
Research Onboarding Working Group, 2023
Edwards Lifesciences Research Advisory Committee, 2024
Certification
Licensed Vocational Nurse, 2011
CPR Certified, 03/01/23
Stanford CROP Certification, 03/01/23
MRS Certified, 01/01/23
IV Certified, 09/01/10
Collaborative Institutional Training Initiative (CITI) Research Ethics Training Certifications, Human Subject Research, Good Clinical Practice Certification, HIPAA Certification
Other
Conversational Spanish, Microsoft Office suite, Epic Electronic Health Records System, REDCap Database
Professional Publications
Akurassa Hewage, S., St. Fleur, M., Kotadia, S., Flores, T., Wood, E., Tafoya, E., Okumu, A., Hughes, T., Sinclair, D., Olatunde, P., Nuñez, M., & Hurtado, J. (2025). Beyond technical skills: Building communities of support for research staff. Advice & News, Stanford School of Medicine.
Peer-Reviewed Publications
Woo, Y. J., Boyd, J., Villanueva, R., Benjamin-Addy, R., Vesom, N., Flores, T., Bakshi, K., Lee, A., Hiesinger, W., & Liang, D. (Year). Pacemaker implantation associated with tricuspid repair in the setting of mitral valve surgery: Insights from a Cardiothoracic Surgical Trials Network randomized trial. Journal Name, Volume(Issue), pages.
Timeline
Clinical Research Manager 2
Stanford School of Medicine-Cardiothoracic Surgery
09.2019 - Current
Senior Clinical Research Coordinator
Stanford School of Medicine-Cardiothoracic Surgery
01.2016 - 09.2019
Clinical Research Coordinator/ Clinical Administrative Associate
Stanford School of Medicine-Cardiothoracic Surgery
10.2014 - 01.2016
Licensed Vocational Nurse/CRC
Pacific Brain & Spine Medical Group
11.2012 - 10.2014
Licensed Vocational Nurse/CRC
Dr. Patrick Bitter JR. MD
11.2012 - 10.2014
Licensed Vocational Nurse - Advanced Research Laboratory in Experimental Biology, Molecular and Cellular Immunology, Translational Immunology, Introduction to Laboratory Research in Cell and Molecular Biology, Cell Biology and Animal Physiology, Tumor Immunology