Coral Gables, Florida, United States · Hybrid
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Safety Management, Regulatory Reporting, Pharmacovigilance, Medical Data Analysis, Clinical Trial Management Software
Coral Gables, Florida, United States · Hybrid
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Human Research, Data Collection, Participant Recruitment, Biological Sample Collection, Statistical Analysis
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Chemotherapy Administration, Infusion Therapy, Patient Assessment, Nursing Care Planning, Medical Equipment Operation
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: EEG Recording, Patient Interviewing, Equipment Calibration, Data Analysis, Technical Troubleshooting
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Robotics, Applied Artificial Intelligence, Mechatronics, Autonomous Systems, Control Systems
Coral Gables, Florida, United States · On-site
Field Interviewers on the National Survey on Drug Use and Health (NSDUH) are responsible for: Traveling frequently to selected locations to recruit study participants Making in-person contact with selected respondents to…
Skills: Communication, Data Collection, Interviewing, Time Management, English Fluency
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Patient Care, Vital Signs, EKG, Phlebotomy, Medical Terminology
Coral Gables, Florida, United States · On-site
$18/hr–$22/hr
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Animal Husbandry, Non-Human Primate Handling, Biological Sample Collection, Medication Administration, Sterilization
Coral Gables, Florida, United States · On-site
$18/hr–$22/hr
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Animal Husbandry, Biological Sample Collection, Medication Administration, Sterilization, Environmental Enrichment
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Research Planning, Data Analysis, Literature Review, Scientific Writing, Inventory Management
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Primary Care, Internal Medicine, Patient-Centered Care, Clinical Research, Medical Education
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Cardiovascular Imaging, Echocardiograms, CT Scans, MRI Scans, Nuclear Cardiology
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Primary Care, Diagnosis and Treatment of Complex Illnesses, Health Promotion, Disease Prevention, Clinical Research
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Surgical Pathology, Anatomic Pathology, Clinical Pathology, Cytopathology, Intraoperative Evaluations
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Tissue Processing, Sectioning, Immunohistochemistry, Microtomy, Cryotomy
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Radiation Therapy, Patient Positioning, Radiation Safety, Computerized Simulation, Treatment Planning
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Phlebotomy, Vital Signs Monitoring, EKG, Patient Care, Medical Documentation
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Clinical Research Coordination, Protocol Implementation, Regulatory Compliance, Study Recruitment, Sample Processing
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Laboratory Experiments, Data Analysis, Statistical Analysis, Participant Recruitment, Informed Consent
Coral Gables, Florida, United States · On-site
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty…
Skills: Laboratory Equipment, Data Analysis, Animal Handling, Molecular Biology, Microbiome Analysis
Coral Gables, Florida, United States • Hybrid
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The role involves reviewing and evaluating serious adverse event reports to ensure regulatory compliance and maintaining safety databases. The associate will draft narratives, prepare safety reports for authorities, and develop safety management plans for investigator-initiated trials.
A bachelor's degree in healthcare or science is required, with a minimum of 4 years of experience in clinical trials. Proficiency in GCP, FDA regulations, and medical data analysis is essential.
Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet.
The Department of Executive Dean of Research is currently seeking a Clinical Research Safety Associate to work in Miami.
The Clinical Research Safety Associate (CRSA) supports and assists with safety management and reporting of University of Miami sponsored clinical trials within the Investigator-Initiated Trial Services at the University of Miami. This role involves reviewing and evaluating serious adverse event reports (SAERs) and Adverse Events of Special Interest (AESI) to ensure compliance with regulatory reporting requirements, maintaining adverse event data in safety databases, and drafting narratives. Responsibilities include collaborating with stakeholders to gather additional safety information, preparing regulatory safety reports, monitoring safety literature, and contributing to developing safety policies and risk management plans. The CRSA works closely with clinical research, regulatory affairs, and pharmacovigilance teams to maintain the safety and compliance of investigational products.
Review and evaluate Serious Adverse Event Reports (SAERs) and Adverse Events of Special Interest (AESIs) for compliance with regulatory reporting and funding entity requirements.
nsure that reported SAER and AESI event reports are received, tracked, evaluated, processed and distributed/submitted in an efficient and timely manner, and in compliance with regulations, funding entities requirements and IITS-U Safety Management Plans/SOPs.
Generate appropriate queries for study teams to complete and clarify SAE information as needed.
Ensure consistency in investigator causality assessment of SAERs, source documentation, and Reportability Assessment Forms (RAFs) for completeness, accuracy and legibility.
Maintain accurate and up-to-date safety information in safety databases and trackers to ensure proper documentation for audits and inspections.
Draft comprehensive and clear narratives for adverse events to support regulatory submission and study records.
Prepare safety reports, including MedWatch and CIOMS forms, for submission to regulatory authorities and funding entities in a timely and accurate manner.
Prepare safety documentation using requested format by funding entity.
Create and maintain study-specific SAE or AESI forms for study use.
Draft and maintain study specific comprehensive safety management plans, including workflow creation, for investigator-initiated trials to ensure consistent safety oversight.
Contribute to the creation and refinement of safety Standard Operating Procedures (SOPs) and risk management plans to align with Good Clinical Practices.
Assist with training of study team members on the safety reporting expected for the study, including how to complete SAE and/or AESI forms, timelines associated with completing the forms, and how to respond to associated queries on the data submitted.
Participate in the standardized set-up of new safety databases.
Help in compiling safety data required for Project Status Reports, DSMC meetings and other requests as applicable.
Perform SAE reconciliation.
Liaise with other units and departments.
Participate in inspection-readiness activities including documentation needed for eTMF.
Support the Medical Monitor in the review and development of written materials including clinical trial protocols, SAE and AESI reporting forms, and Reportability Assessment Forms.
Inform study team of safety related issues and potential trends and or signals arising from review of data
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities, as necessary.
Bachelor’s degree in health care, science or related field required. Master’s degree or higher preferred.
Clinical research certification (e.g. ACRP, SOCRA) preferred
Minimum 4 years of experience with clinical trials (involving drugs, biologics or devices) required. Experience working as a clinical research monitor preferred
Strong knowledge of Good Clinical Practice (GCP), FDA regulatory requirements and ICH-GCP guidelines
Excellent English skills, both verbal and written
Excellent interpersonal and team skills
Strong attention to detail, time/project management and organization skills
Strong Microsoft Office (Excel, Outlook, PowerPoint, Word) skills
Proficiency in medical data analysis and interpretation.
Proficiency in using clinical trial management software.
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Offices: 5915 PONCE DE LEON BLVD, Coral Gables, Florida 33146, us
View all jobs at University of Miami Health System-UhealthThere are currently 663 open science & research positions in Coral Gables, FL listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include University of Miami Health System-Uhealth, University of Miami Health System, Coral Gables Hospital, Baptist Health, AECOM, among others. Browse the listings above to see every active employer.
Yes — 41 of the 663 open science & research positions offer remote or hybrid work (6 remote, 35 hybrid).
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