Janet Jaime
Los Angeles,CA
Summary
Regulatory affairs professional with over 8 years of experience supporting clinical research operations, regulatory compliance, and regulatory documentation to ensure compliance with FDA regulations, Institutional Review Board (IRB) requirements, and Good Clinical Practices (GCP) guidelines.
Overview
2
2
Languages
1
1
Certification
12
12
years of professional experience
Work History
Clinical Research Regulatory Manager
Long Beach VA Healthcare System, SCIRE
Long Beach, CA
06.2026 - Current
- Prepare regulatory packages for submission to obtain VA and IRB approval in efforts to maintain compliance with VA and federal requirements.
- Manage regulatory submissions for study amendments to ensure regulatory compliance with federal regulations
- Maintain regulatory binders, approvals, and study files, enhancing audit readiness and compliance oversight.
- Communicate with VA offices, sponsors, and auditors on regulatory issues.
- Assist in developing internal policies (standard operating procedures)
- Facilitate study personnel interviews for SCIRE and the VA onboarding process
Regulatory Affairs Specialist II
City of Hope, Duarte
Duarte
05.2024 - Current
- Assisted Department of Hematology (Diamond Lab) with regulatory submissions for pre-clinical studies, IACUC protocols, IBC submissions, and IRB continuations, ensuring compliance with regulatory requirements.
- Developed SOPs for the lab
- I facilitated biostatistics discussions for experimental designs with scientists and lab personnel
- Submitted responses to IND FDA non-hold comments
Clinical Research Regulatory Administrator
USC Radiology
06.2023 - 05.2024
- Oversaw regulatory aspects, monitoring 100+ active projects, including IRB submissions, amendments, and annual reviews for investigator-initiated and industry-funded studies.Assisted investigators in creating protocols, informed consent forms, and data collection, while managing audits and maintaining regulatory binders. Facilitated onboarding process for new medical researchers, streamlining integration into research protocols.
Regulatory Assistant
USC Radiology
05.2021 - 05.2023
- Assisted the Department's Regulatory Manager and Radiology faculty with regulatory compliance for research personnel across radiology studies by maintaining regulatory binders, submitting study amendments and reportable events, and writing protocols and ICFs.
Clinical Research Coordinator I
Children's Hospital Los Angeles
07.2018 - 04.2021
- Directed and managed clinical trials, including multi-phase studies and investigator-initiated projects. Responsibilities included collecting patient data, submitting IRB applications, negotiating contracts and budgets with sponsors, processing invoices, creating research accounts, recruiting subjects through phone, flyers, and ads, submitting regulatory documents, ordering lab supplies, preparing specimens for shipment, and creating clinical source documents.
Pharmacy Transporter
UCLA Medical Center
Santa Monica, CA
10.2018 - 10.2019
- Under direct supervision of registered pharmacists- deliver medications to hospital nursing stations. Delivered medications to nursing stations under supervision of registered pharmacists, signed off by pharmacists; processed urgent medication requests via p-tube system, verified chemotherapy orders, disposed of expired medications, and restocked supplies.
Education Specialist/Sports Coach
08.2014 - 10.2018
- Saturday Academy Mathematics Tutor: provided supplemental instruction to 6th grade students by teaching new weekly math lessons that reviewed important algebraic concepts.
Clinical Allergy and Immunology Research Assistant
Children's Hospital Los Angeles
10.2017 - 07.2018
- Supported CRCs in clinical research by recruiting subjects, submitting IRB applications, and submitting data collection to electronic data capture (EDC) systems
Neighborhood Academic Initiative Science (NAI) Coordinator
02.2017 - 10.2017
- Executed science classes by managing supply inventory and designing exams/quizzes to enhance student learning outcomes
- Developed and provided science teachers and assistants with a structured curriculum aligned to designated grade levels
Production Assistant
USC Marshall Online MBA Program
08.2015 - 12.2016
- Assisted producers and instructional designers with online graphic searches, lecture/studio recording, monitoring teleprompter and time-codes, and posting lectures for student access via Canvas portal, facilitated WebEx and Zoom virtual meetings, and trained new incoming staff members.
Volunteer
Children's Hospital (CHLA)
08.2014 - 04.2015
- Supported the mission of the 'At Your Service' program by engaging with families and children
Education
Master of Science - Regulatory Science
USC School of Pharmacy
Los Angeles, CA12-2021
Bachelor of Science - Health Promotion and Disease Prevention Studies
USC Keck School of Medicine
Los Angeles, CA12-2016
Minor - Dance in Popular Culture: Hip-Hop, Urban and Social Dance
USC Kaufman School of Dance
Los Angeles, CASkills
- Technology: Office, Powerpoint, Teleprompter, Electronic Medical Record, Pxsis Medstation, Oncore, Rave (iMedidata), iSTAR, iRIS, IRBNet, Advarra IRB, WCG IRB
Certification
Human Subjects, Good Clinical Practices, HIPAA, IATA
Languages
English
Native/ Bilingual
Spanish
Native/ Bilingual
Honors and Awards
USC Neighborhood Academic Initiative (NAI) Scholar (college preparatory program), USC NAI Undergraduate Scholarship (full tuition coverage), USC Latino Alumni Scholarship (Fall 2020/Spring 2021), Advancement of Regulatory Science Scholarship (Spring 2021)
Timeline
Clinical Research Regulatory Manager
Long Beach VA Healthcare System, SCIRE
06.2026 - Current
Regulatory Affairs Specialist II
City of Hope, Duarte
05.2024 - Current
Clinical Research Regulatory Administrator
USC Radiology
06.2023 - 05.2024
Regulatory Assistant
USC Radiology
05.2021 - 05.2023
Pharmacy Transporter
UCLA Medical Center
10.2018 - 10.2019
Clinical Research Coordinator I
Children's Hospital Los Angeles
07.2018 - 04.2021
Clinical Allergy and Immunology Research Assistant
Children's Hospital Los Angeles
10.2017 - 07.2018
Neighborhood Academic Initiative Science (NAI) Coordinator
02.2017 - 10.2017
Production Assistant
USC Marshall Online MBA Program
08.2015 - 12.2016
Education Specialist/Sports Coach
08.2014 - 10.2018
Volunteer
Children's Hospital (CHLA)
08.2014 - 04.2015
Master of Science - Regulatory Science
USC School of Pharmacy
Bachelor of Science - Health Promotion and Disease Prevention Studies
USC Keck School of Medicine
Minor - Dance in Popular Culture: Hip-Hop, Urban and Social Dance
USC Kaufman School of Dance