Olivia Ayanruoh
San Jose
Summary
Clinical and research professional with 4+ years of experience in clinical research and healthcare operations. Strong knowledge of clinical trials in medical devices, pharma, and biotechnology companies. Seeking to contribute unique insight of complex remote studies and operational workflows to innovative research projects.
Overview
6
6
years of professional experience
Work History
Clinical Trial Associate
May Health
09.2023 - Current
- Assisted with study start up activities for 15+ sites including all regulatory document collection, filing, and research coordinator training.
- Feasibility/Qualification (QV), Site Initiation (SIV)
- Maintained detailed tracking systems including protocol & document revisions, IRB submissions, operations budgeting, and participant enrollment dashboard for external stakeholders
- Clinical SOP and form review
- Creation and implementation of comprehensive device management plan.
- Assisted with eTMF set-up, implementation, and audit Plan that successfully ensured the clinical success of 3 company audits
- Developed, coordinated, and shipped participant facing supplies and recruitment material packets to study sites
- Helped to draft Central Lab Manual for specimen collection at study sites following study design and coordinator input
- Ensured programs and Quality Systems requirements were in place and followed, by providing guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.
- Enhanced patient recruitment through marketing agency developing targeted outreach strategies for diverse populations.
- Managed investigational product inventory levels, ensuring adequate supply for all enrolled patients at each study location.
- Worked with CRAs to manage all regulatory (ISF) documents and source worksheets
- Helped to develop automated payment process for site reimbursement to ensure accurate and timely payments
Clinical Trial Assistant
Verily, Google Life Sciences
06.2022 - 09.2023
- Responsible for assisting in operational management of the company's first fully de-centralized study involving 80+ participants
- Conducted 70+ on-site study sessions with adults over age 50 utilizing an early heart failure device
- Conducted 70+ in person and virtual follow-up interviews for study participants that ranged from 24 hour to one year follow-up
- Maintained screening and enrollment trackers to capture essential
- Assisted study manager in IRB submissions and protocol amendments
- Executed successful close-out procedures between the sponsor and study sites including query resolution and database lockout.
- Responsible for filing and maintaining the Trial Master File (TMF and e-TMF)
- Prepared and dispersed study-related documents,
including consent forms and recruitment materials to study sites. - Maintained all regulatory binders including
Clinical Study Coordinator
Guardant Health
03.2021 - 06.2022
- Managed Site Files (ISF) and Site Study Binders (SSB) to meet ICH/GCP requirements
- Created and executed study-specific plans and protocols for new pharma partners
- Assisted in creating cross functional collaboration between lab teams and clinical study coordinators
- Managed all Research Use Only studies and acted as lead for 4 external and internal audits with large PharmD partners
- Filed, tracked, and maintained study activity for 5+ studies both retrospectively and prospectively
- Ensured trial monitoring activities were completed per sponsor and site protocols
- Assisted team with study supplies management
- Conducted study tracking activities (sample status, reconciliation activities, filing, archiving)
- Assisted with meeting coordination: scheduling meetings, meeting agendas, meeting minutes, meeting materials
- Worked with quality team to review and implement effective electronic organizational processes
Clinical Research Coordintor -Consultant
WCG-ThreeWire, Inc
01.2021 - 03.2021
- Responsible for chart review, prescreening, medical record retrieval, and processing media referrals
- Gathered patient consent for 200 participants
- Patient Retention Tasks: Data Entry, Source Document Storage, E-Diary Compliance & Study Visit Preparation
- Screened patients against study criteria for enrollment
- Educated patients on clinical trials and investigational drugs/devices, and answer study-related questions
- Maintained and updated multiple portals to track patient interactions throughout study participation
Patient Care Navigator
UCSF Medical Center
02.2020 - 12.2020
- Navigated over 30 patient & employee inbound and outbound calls per day for COVID hotline
- Inputted information in various medical systems such as EPIC and APEX using appropriate workflows
- Assisted with improving user surveys for tracking increased COVID diagnoses
- Troubleshoot clinical concerns as per COVID Hotline protocol
- Worked collaboratively with nurse coordinators and department staff to triage employees
- Assisted patients with care coordination, appointment scheduling, and medication management
Intake Specialist/ Clinic Assistant
Rogers Memorial Behavioral Health
01.2019 - 01.2020
- Recruited, enrolled, registered, and scheduled patients for treatment programs
- Provided front desk assistance and perform administrative duties (faxing, scanning, and supply ordering)
- Conducted pre-admission screenings based on inclusion/exclusion criteria
- Coordinated adult and child admissions including consent forms
- Helped manage 40+ electronic patient records with rolling admission schedule
- Assisted with all management scheduling and organize clinic events
- Recorded meeting minutes and generate expense reports
- Coordinated care with internal & external healthcare providers
- Interpreted medical notes and performed utilization reviews for insurance companies
- Analyzed and tracked incoming patient data demographics for marketing
- Collaborated with clinical and administrative staff regarding patient care
Education
Bachelor of Science - Psychology, Neuroscience
Saint Mary’s College of California
Moraga, CA01.2019
Skills
- Written and Verbal Communication Skills
- Research Participant Evaluation and Assessment
- Data Analysis
- GCP and HIPAA policies
- Monitoring Plans
- Clinical Trials and Research
- Particpant Recruitment
- Experience working on interdisciplinary teams
- Outlook, eTMF systems, JIRA, EDC systems, Tableau, Confluence, Trello, WorkDay, MS Office Suite, Mac and PC platforms, SmartSheets, Cerner & Epic (Medical Charts), PubMed, REDcap
Timeline
Clinical Trial Associate
May Health
09.2023 - Current
Clinical Trial Assistant
Verily, Google Life Sciences
06.2022 - 09.2023
Clinical Study Coordinator
Guardant Health
03.2021 - 06.2022
Clinical Research Coordintor -Consultant
WCG-ThreeWire, Inc
01.2021 - 03.2021
Patient Care Navigator
UCSF Medical Center
02.2020 - 12.2020
Intake Specialist/ Clinic Assistant
Rogers Memorial Behavioral Health
01.2019 - 01.2020
Bachelor of Science - Psychology, Neuroscience
Saint Mary’s College of California
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