Dana Levin-Lopez
Stevenson Ranch,CA
Summary
Versatile clinical research professional knowledgeable about FDA regulated sponsor and sponsor-investigator clinical trials.
Overview
11
11
years of professional experience
Work History
Clinical Research Manager
UCLA Health
09.2019 - Current
- Oversees three teams of study and regulatory coordinators working on combination of industry, investigator initiated, and grant funded clinical trials in department of Urology and OBGYN
- Directed growth of clinical trials from one unit with two direct reports to three distinct units with 10 direct reports in under four years
- Responsible for overseeing study start-up, implementation, quality control, and tracking metrics for unit
- Implemented invoicing system, leading to 60% increase in revenue
- Conducts quality assurance activities to ensure compliance with federal, state, and local regulations
- Established standard operating procedures to streamline start-up and ensure compliance during study conduct
- Analyzes departmental metrics related to enrollments, deviations, adverse events, and data submission timeliness
- Leads team to report any Serious Adverse Events, Protocol Violations, or other events in a timely manner
- Established effective monitoring systems to track progress and identify potential issues in ongoing clinical trials.
- Develops comprehensive budgets for clinical research projects, optimizing resource allocation and cost-efficiency.
- Manages multi-site clinical studies, ensuring timely completion and compliance with regulatory standards.
- Spearheads interdepartmental collaboration for improved communication and resource sharing in clinical research projects.
Clinical Research Specialist
Cedars-Sinai Medical Center
05.2018 - 09.2019
- Oversaw multiple medium-scale oncology investigator-initiated clinical trials from inception to study closure, including protocol development, regulatory submission, clinical coordination, and study closure with a focus on prostate cancer
- Navigated multiple high priority assignments including NIH and DOD grant deadlines, patient care crises, and urgent regulatory issues
- Responsible for 44 studies’ regulatory submissions to local IRB including initial submission, amendments, continuing reviews, reliance reviews, adverse events/other reports to the IRB, and Medicare Cover Analysis
- Provided day-to-day guidance, oversight, and troubleshooting for clinical research coordinators as Team Lead, including oversight of study visits, regulatory submissions, and data management
- Assisted principal investigators in preparing grant proposals, securing funding for critical research projects
Clinical Research Coordinator
Cedars Sinai Medical Center
03.2016 - 05.2018
- Provided coordination for 7 oncology clinical trials for extended period during severe staff shortage while also training new team members
- Studies included therapeutic, lifestyle intervention, and psychosocial trials while including clinical and regulatory responsibilities
- Prepared protocol deviation reports, source documentation, completed eCRFs in multiple electronic databases, scheduled patient visits and lab draws, and ensured study activities were completed per protocol
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
Graduate Student Researcher
UCLA
07.2013 - 03.2016
- Staff Research Associate II
- Research coordination for PURPOSE social media study and START follow-up study
- Assisted in Data Security Management Protocol creation, Study Protocol editing, IRB submission and approval process, and clinicaltrials.gov registration
- Conducted literature reviews on topics related to substance use disorders and sexual health behaviors
- Coordinated data monitor visit and assisted in resolving protocol deviations and violations
- Tracked, located, and surveyed participants in CTN-0050 START follow-up study
- Experience in data management, entry, and coding
- Consented interview participants and administered standard assessments.
Education
MPH Community Health Sciences -
University of California, Los Angeles
Westwood, CA03.2016
B.A. Biological Sciences -
University of Southern California
Los Angeles, CA05.2012
Skills
- Organizational Skills
- Regulatory Compliance
- Project Coordination
- Clinical Data Management
- Good Clinical Practice
- Quality Assurance
Timeline
Clinical Research Manager
UCLA Health
09.2019 - Current
Clinical Research Specialist
Cedars-Sinai Medical Center
05.2018 - 09.2019
Clinical Research Coordinator
Cedars Sinai Medical Center
03.2016 - 05.2018
Graduate Student Researcher
UCLA
07.2013 - 03.2016
MPH Community Health Sciences -
University of California, Los Angeles
B.A. Biological Sciences -
University of Southern California