BayCare Health System: Operates non-profit hospitals and outpatient healthcare facilities in Florida.
3+ YOESupervise regulatory team, manage IRB and FDA submissions, register trials on ClinicalTrials.gov; requires 3 years research regulatory submissions experience and a bachelor's degree.
Sentara Health: Operates hospitals and provides health insurance and medical services
3+ YOEBSN required (or 5 years clinical research/healthcare administration), 3 years clinical research or healthcare administration experience, IRB/regulatory documentation and audit preparation experience.
Tennessee Oncology: A leading community-based oncology practice.
Bachelor’s degree in life sciences (preferred); experience with regulatory processes and clinical research; strong knowledge of medical terminology and data collection.
Brown University Health: Provides clinical care, medical education, and biomedical research services.
0.5+ YOESupport regulatory aspects of clinical trials, prepare and collect regulatory documents, process safety reports, assist with monitoring and sponsor visits; detail-oriented with strong communication and Microsoft Office/database skills.
Microsoft Office, Clinical Trial Management System
OSF HealthCare: Integrated health system providing medical and hospital care services.
2+ YOEHigh school diploma/GED required; bachelors or 4 years healthcare/research experience; 2 years clinical research experience; strong communication, analytical, and Microsoft software skills; detail oriented.
Smith Allergy & Asthma Specialists: Provides diagnostic and treatment services for allergies and asthma.
2+ YOE2+ years clinical research regulatory experience, Associate's degree, IRB submission and regulatory maintenance experience, REALTIME and Microsoft Office proficiency, knowledge of ICH-GCP and FDA regulations.
Keck Medicine of USC: Provides specialized medical care and research via university health system.
3+ YOE3+ years clinical research/regulatory experience, knowledge of FDA/ICH-GCP, eRegulatory and CTMS/EDC platforms, strong organization, training, and communication skills.
Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), electronic Investigator Site File (eISF), eBinder, Florence eBinders, Complion, Google suite, Slack, Skype
Urology San Antonio: Provides specialized medical and surgical care for urological conditions.
Prepare and submit IRB and regulatory documents, maintain regulatory binders, ensure compliance with FDA/ICH/GCP/HIPAA/IRB requirements, and respond to sponsor/IRB queries.
University of Southern California: Private research university providing higher education and healthcare services.
3+ YOE3+ years clinical research/regulatory experience, bachelor\u0002s in life sciences or related field (or equivalent), knowledge of FDA/ICH-GCP, eRegulatory/CTMS/EDC platforms, training and change management skills.
Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Electronic Investigator Site Files (eISF), Florence eBinders, Complion, Google suite, Slack, Skype
Temporary Clinical Research Regulatory Coordinator
Orange, California, United States
$38/hrHybridFull Time
University of California, Irvine: Public research university offering higher education and academic degrees.
3+ YOEBachelor's or equivalent, 3–5 years regulatory clinical research experience, knowledge of FDA/GCP/IRB, ability to manage multiple regulatory projects, strong organizational and communication skills.
Carle Health: Integrated healthcare system providing hospital and clinical services.
Experience with clinical research regulatory processes, IRB/HIPAA compliance, informed consent review, CITI training, and CCRP certification within 3 years; bachelor's degree or equivalent experience in a related field.
Clinical Research Regulatory Specialist - SMS-3831
Springfield, Illinois, United States
$44k-$48k/yrOnsiteFull Time
SIU Medicine: Provides medical education and clinical healthcare services.
Bachelor's degree required; support clinical research operations, regulatory submissions, IRB and FDA compliance, maintain regulatory files and databases, perform QA and patient data collection.
Microsoft Access, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, eREG
United Urology Group: Provides management and clinical support services for urology practices.
2+ YOEMaintaining regulatory files, managing IRB/IBC submissions, current GCP certification, 2+ years related experience, HS diploma required; BA/BS preferred, strong regulatory knowledge and computer skills.
Microsoft Windows, Microsoft Word, Microsoft Outlook, Microsoft Excel, Microsoft PowerPoint, Microsoft Publisher, Clinical Trial Master Systems, Electronic Data Capture Systems
Clinical Research Regulatory Coordinator (Brandon, Florida)
Brandon, Florida, United States
HybridFull Time
Cardiovascular Associates of America: Operates a national network of cardiovascular medical practices.
2+ YOEAssociate degree required; 2+ years clinical research regulatory experience; IRB submissions, REALTIME eRegulatory experience preferred; strong knowledge of ICH-GCP and FDA regs; proficiency with electronic regulatory systems and Microsoft Office.
REALTIME CTMS, REALTIME eRegulatory, Microsoft Office
University of Alabama at Birmingham: Provides academic education, medical research, and clinical healthcare services.
Assist with IRB submissions and tracking, maintain regulatory binders and eISFs, ensure compliance with ICH-GCP/FDA/HIPAA, perform QA audits, and use electronic regulatory systems.
Microsoft Office, MURE, IRAP, Florence e-binder system, Veeva Vault
Sr. Research Regulatory Specialist (Full Time, Days)
Miami, Florida, United States
OnsiteFull Time
Nicklaus Children's Health System: Provides specialized healthcare services for children and adolescents.
4+ YOEBachelor's degree or 4 years clinical research experience; 4-7 years regulatory affairs experience managing complex clinical trial portfolios; ACRP or CCRP; Phase 1 and oncology trial experience; proficiency with CTMS, OnCore, Florence eTMF, REDCap, and Microsoft Office.
CTMS, OnCore, Florence eTMF, REDCap, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint