SAB BiotherapeuticsNASDAQ: SABS: Developing human antibody-based immunotherapies using a bovine platform.
6+ YOEB.S. degree,6+ years clinical trial management experience,GCP and FDA/EMA/MHRA knowledge,experience with EDC/CTMS/eTMF and MS Office,leadership and budgeting skills.
EDC, CTMS, eTMF, Veeva, Agatha, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Smartsheet
Clinical Research Safety Associate - Hybrid, Miami FL
Miami, Florida, United States
HybridFull Time
University of Miami: Provides higher education, academic research, and healthcare services.
4+ YOEBachelor's degree required, 4+ years clinical trials experience, strong GCP/FDA knowledge, clinical research certification preferred, proficiency with Microsoft Office and eTMF, strong writing and analytical skills.
Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, eTMF
Palo Alto or Princeton or Miami or California or New Jersey or United Kingdom or Ireland
$117k-$137k/yrOnsiteFull Time
Summit TherapeuticsNASDAQ: SMMT: Developing oncology therapies to improve patient quality of life.
4+ YOEBachelor's degree in biological, health, or medical sciences or equivalent experience; 4+ years in a CRO or pharmaceutical clinical study environment; CTMS and eTMF experience; FDA, GCP, and ICH knowledge.
Clinical Trial Management Systems (CTMS), Clinical Trial Master File Systems (eTMF), CTMS, EDC
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
5+ YOEDegree in life sciences (or equivalent), 5+ years clinical research/operations experience, expert knowledge of ICH/GCP, proven site relationship management, strong communication/negotiation skills, willingness to travel 30–50%.
Clinical Research Associate (CRA) - Cardiovascular (Remote)
Rahway or Miami Beach or Fort Lauderdale or Miami or Boca Raton or Key Largo
$96k-$151k/yrRemoteFull Time
Merck & Co.NYSE: MRK: Produces prescription medicines, vaccines, and animal health products.
2+ YOEFluent Spanish/English, valid driver’s license, 2+ years direct site monitoring experience (or equivalent), knowledge of ICH/GCP and clinical trial processes, ability to travel ~65–75%.
Clinical Research Associate (CRA) - Cardiovascular (Remote)
Rahway or Florida or Fort Lauderdale or Miami or Miami Beach or Boca Raton or Key Largo
$96k-$151k/yrRemoteFull Time
Merck & Co.NYSE: MRK: Develops and manufactures prescription medicines, vaccines, and animal health products.
2+ YOESpanish and English fluency, current driver's license, and an associate degree with 5 years' healthcare experience or bachelor's degree with 2 years' monitoring experience in bio/pharma or CRO.