Ruijin Geng
Marietta,GA
Summary
5 years clinical research and clinical trial experience with school of medicine and Biotech company. Dedicated clinical research coordinator experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Experienced in fast-paced environments and adaptable to last-minute changes. Thrives under pressure and consistently earns high marks for work quality and speed.
Overview
5
5
years of professional experience
Work History
Global Clinical Research Operation Supervisor
Sinovac Biotech Ltd.
Beijing, China
09.2021 - 05.2023
- Managed project timeline and tracked progress to ensure milestones are able to realize within plan, assisted CRO contract and CTAs reviewing and budget negotiations
- Assisted manage all operational aspects of multi-center studies including study Start-Up activities (IRB/IND submission, Site Evaluations Selection, and Central Lab and global Depot setup, IRT and EDC set up etc.) and ongoing study management by coordinating with CRO, third-party vendors and internal functional teams
- Responsible for the trial level clinical operations budget, invoices, and change orders
- Participated in evaluation and selection of study vendors including Global CRO and Central lab etc
- Conducted the development/review of trial essential documents, including study protocols, Informed Consent (ICF), Diary card, CRF (case report form), CRF Completion Guidelines, Study Management Plan, Monitoring plan, Pharmacy manual, Lab manual etc
- Lead the team meetings with CRO regularly including logistics and material preparation, to resolve barriers to ensure timely study activation, and to discuss potential solutions for milestones are reached
- Development of new SOPs for Medical Monitoring processes
- Performed site CO-monitoring with CRO Site Monitors for site visit to ensure site coordinators adhere to GCP and study protocol including confirmation of subject eligibility, proper informed consent process & documentation, in Global Site Chile.
Clinical Research Assistant II/ Research Coordinator
Morehouse School of Medicine
Atlanta, GA
01.2019 - 06.2021
- Managed data entry and queries timely, and conducted SDR & SDV to ensure clinical data integrity that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs
- Manage payment and tracking of participant stipends and other budget expenditures
- Managed essential documents as required by ICH-GCP guidelines before and during clinical trial, and resolved some complicated data queries with assisted of site monitor
- Designed pre-screening survey by using REDCAP, and monitored pre-screening progress
- Developed and maintained study enrollment (COVID19 infection cases, acute illness, AE, SAE, Protocol Deviation etc) dashboard and status reports for senior management
- Developed Site Data Management Guideline and provided training for junior team members.
Regulatory Affairs Assistant
ACON Laboratories, Inc.
San Diego, CA
08.2018 - 12.2018
- Registered several New Global Products in Europe
- Coordinated Clinical Trials recruitment for ACON Medical Devices testing, including interfaced with research participants, determines eligibility and consented study participants according to protocol.
Research Assistant
University of Georgia
Athens, GA
04.2018 - 07.2018
- Qualitative data management and analysis: transcribed Chinese interviews to English and performed qualitative data coding by using Nvivo software and Excel, for project of Advancing Parenting Skills: Feasibility study for an Early Childhood Intervention Using Text Messaging in Rural China
- Contribute to manuscript for publication: contributed to methodology and results sections for the manuscript.
Research Intern—Pediatric Falls Injury Prevention Project
Children’s Healthcare of Atlanta (CHOA)
Atlanta, GA
- Analyzed risk factors of pediatric falls from Emergency Department EMR by using R and reported results
- Conducted Literature review and designed Cross Sectional Study for Pediatric Falls research
- Developed Study Protocol and CRF for Pediatric Emergency Department Falls Patients and got approval from both Emory University and CHOA Institutional Review Board (IRB).
Education
Master of Public Health, Epidemiology -
University of Georgia
USA12.2018
Master of Medicine, Social Medicine and Health Management -
Kunming Medical University
China12.2014
Bachelor of Agriculture, Plant Science and Technology -
Huazhong Agricultural University
China12.2011
Skills
- Protocol development
- Documentation requirements
- Research experience
- Records Maintenance
- Schedule Coordination
- Documentation Management
- Data Analysis
- Database organization
- Quality Assurance
- Protocol Review
Publications
- Assessing Feasibility of an Early Childhood Intervention Using Mobile Phones Among Low-Income Mothers of Newborns: Qualitative Interview Study, Donglan Zhang, PhD; Lan Jin, PhD; Di Liang, PhD; Ruijin Geng, MPH; Yun Liu, MD; Yu Lin, MD; Fan Jiang, MD, PhD; Yunting Zhang
- PhD, JMIR Form Res, 2020-05-28, 10.2196/17179
- Increased Risk of Sub-Clinical Blood Lead Levels in the 20-County Metro Atlanta, Georgia Area—A Laboratory Surveillance-Based Study, Dickinson-Copeland, Carmen & Immergluck, Lilly & Britez, Maria & Yan, Fengxia & Geng, Ruijin & Edelson, Mike & Kendrick-Allwood, Salathiel & Kordas, Katarzyna, International Journal of Environmental Research and Public Health, 2021, 10.3390/ijerph18105163
- Space Time Trends of Community Onset Staphylococcus aureus Infections in Children Living in Southeastern United States: 2002-2016, Immergluck, Lilly & Geng, Ruijin & Li, Chaohua & Edelson, Mike & Waller, Lance & Rust, George & Xu, Junjun & Ali, Fatima & Baltrus, Peter & Leong, Traci, Open Forum Infectious Diseases, 2021, 10.1093/ofid/ofab466.002
- Space-Time Trends of Community Onset Staphylococcus aureus Infections in Children: A Group Based Trajectory Modeling Approach, Immergluck, Lilly & Geng, Ruijin & Li, Chaohua & Edelson, Mike & Lin, Xiting & Waller, Lance & Rust, George & Xu, Junjun & Leong, Traci & Baltrus, Peter, Annals of Epidemiology, 2023, 10.1016/j.annepidem.2023.03.001
- Machine learning to predict risk for community-onset Staphylococcus aureus infections in children living in southeastern United States, Lin, Xiting & Geng, Ruijin & Menke, Kurt & Edelson, Mike & Yan, Fengxia & Leong, Traci & Rust, George & Waller, Lance & Johnson, Erica & Immergluck, Lilly, PloS one, 2023, 10.1371/journal.pone.0290375
- Molecular Epidemiologic and Geo-Spatial Characterization of Staphylococcus aureus Cultured from Skin and Soft Tissue Infections from United States-Born and Immigrant Patients Living in New York City, Immergluck, Lilly & Lin, Xiting & Geng, Ruijin & Edelson, Mike & Ali, Fatima & Li, Chaohua & Lin, TJ & Khalida, Chamanara & Piper-Jenks, Nancy & Pardos de la Gandara, Maria & de Lencastre, Herminia & Tomasz, Alexander & Evering, Teresa & Kost, Rhonda & Vaughan, Roger & Tobin, Jonathan, Antibiotics, 2023, 10.3390/antibiotics12101541
Languages
Chinese (Mandarin)
Native/ Bilingual
Timeline
Global Clinical Research Operation Supervisor
Sinovac Biotech Ltd.
09.2021 - 05.2023
Clinical Research Assistant II/ Research Coordinator
Morehouse School of Medicine
01.2019 - 06.2021
Regulatory Affairs Assistant
ACON Laboratories, Inc.
08.2018 - 12.2018
Research Assistant
University of Georgia
04.2018 - 07.2018
Research Intern—Pediatric Falls Injury Prevention Project
Children’s Healthcare of Atlanta (CHOA)
Master of Public Health, Epidemiology -
University of Georgia
Master of Medicine, Social Medicine and Health Management -
Kunming Medical University
Bachelor of Agriculture, Plant Science and Technology -
Huazhong Agricultural University
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