Lisette Herrera
Van Nuys,CA
Summary
Experienced project manager with over 7 years of experience in clinical trial research. Versatile clinical research professional knowledgeable about managing, coordinating, and monitoring PI-Initiated Phase 1-3 multi-center trials.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Trial Project Manager
Children's Hospital Los Angeles
Los Angeles
07.2022 - Current
- Oversee the maintenance of regulatory integrity of protocols through preparation and submission of the protocol, consent form, protocol amendments, study progress reports and investigational brochures to the IRB for approval in accordance with regulatory and/or IRB guidelines and in compliance with the specified timeline.
- Oversee protocol management at the institutional level to ensure team bandwidth, appropriate team training, cost effectiveness and study activation prior to patient accrual.
- Work in liaison with the COG Site Principal Investigator and departmental associate director to establish and fulfill goals, deadlines and objectives.
- Assign or perform the review of source documentation and extraction of data to accurately record results on electronic data capturing (EDC) systems yielding greater than 95% success at quarterly data cut-offs.
- Led the success of the 2022 Children's Oncology Group (COG) audit by developing a critical path plan detailing the departmental audit objectives, educational initiatives, and actionable items for key players to fulfill identified deadlines.
- Lead on nine Corrective and Preventative Action (CAPA) plans.
- Train medical staff, CRA colleagues, affiliated institutions, other group members, by means of providing protocol and regulatory information, as well as provide in-service sessions for education.
- Developed departmental training program for COG coordinators including coordinator and fellowship onboarding, adverse event training, data completion, and 1:1 protocol initiatives.
- Complete monthly metrics to yield various institution reports.
- Conduct COG Monthly Presentations, providing training, updates and upcoming news.
- Serve as the Leukemia/Lymphoma Supervisor at critical moments ensuring team support and training to in meeting daily demands.
Clinical Research II/III
Children's Hospital Los Angeles
Los Angeles
01.2018 - 07.2022
- Lead coordinator for all activities associated with research protocols assigned including subject recruitment/enrollments, study coordination, data management, regulatory compliance, IRB related activities, study evaluations and subject interfacing.
- Worked closely with Principal Investigators (PIs) and other clinical staff to ensure protocol related procedures were completed per protocol, as well as managed protocol objectives throughout the duration of patient involvement to study close-out.
- Compiled source documentation according to protocol requirements to ensure patient eligibility is reviewed by attending, followed by enrollment, randomization, completing reporting periods, routine adverse reporting, patient chart construction.
- Add audit?
- Onboarded and trained new staff on institutional, departmental and protocol specifics, ensuring exposure to all relevant elements to ensure the success in study coordination.
Clinical Research Coordinator
Southern California Research
Beverly Hills
01.2016 - 10.2018
- Created source documentation for study start-up according to the schedule of assessments, as well as completed the initial regulatory submission to the local IRB.
- Screened and recruited subjects in accordance with protocol eligibility criteria, as well as conducted the on-site medical and psychiatric intake assessments.
- Guided patients throughout the process of informed consent, vital collection, ECG and venipuncture assessments.
- Performed all laboratory processing, study data, and scheduling patients according to protocol windows.
- Completed intake, storage and the dispensation of Investigational Medication Product (IMP), as well as maintaining accountability, reconciliation.
- Hosted site-initiation visit (SIV), interim monitor and close-out visits, while completing real-time query resolution in the EDC.
Education
MBA -
California State University - Channel Islands
Camarillo, CA05.2023
Bachelor of Arts - Psychology
California State University - Los Angeles
Los Angeles, CA12.2021
Skills
- Proficiency in medical terminology
- Excellent attention to detail and commitment to quality
- In depth knowledge of GCP, CFR, and ICH Guidelines
- Ability to effectively problem solve within cross-functional team
- Deep understanding of all aspects of trials, site startup and oversight, study management and site monitoring including quality assurance (QA) and quality control (QC)
- Experience in developing Corrective and Preventative Action (CAPA) Plans
- Excellent organization and time management
- Proficiency in clinical trial software, IT computer literacy, and all Microsoft Office applications
Certification
- Certified Clinical Research Professional (CCRP)
- CITI Good Clinical Practice (GCP) and Human Subject Protection (HSP)
Timeline
Clinical Trial Project Manager
Children's Hospital Los Angeles
07.2022 - Current
Clinical Research II/III
Children's Hospital Los Angeles
01.2018 - 07.2022
Clinical Research Coordinator
Southern California Research
01.2016 - 10.2018
MBA -
California State University - Channel Islands
Bachelor of Arts - Psychology
California State University - Los Angeles