Job Description

Clinical Research Safety Associate page is loaded Clinical Research Safety Associate Apply locations Miami, FL | time type Full time | posted on Posted 2 Days Ago | job requisition id R100083923 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 using the Career worklet, please review this tip sheet . The Department of the Executive Dean of Research is seeking a Clinical Research Safety Associate in Miami. The CRSA supports safety management and reporting for University of Miami sponsored clinical trials within the Investigator-Initiated Trial Services. Responsibilities include reviewing serious adverse event reports (SAERs) and Adverse Events of Special Interest (AESI), ensuring regulatory compliance, maintaining safety data, and drafting narratives. The role involves collaboration with stakeholders, preparing safety reports, monitoring literature, and developing safety policies and risk management plans. The CRSA works closely with clinical research, regulatory affairs, and pharmacovigilance teams to ensure investigational product safety and compliance.

CORE RESPONSIBILITIES

Review and evaluate SAERs and AESIs for compliance with regulatory and funding requirements. Ensure timely receipt, tracking, evaluation, processing, and submission of safety reports in accordance with regulations and SOPs. Generate queries for study teams to clarify SAE information as needed. Maintain consistency in investigator causality assessments and documentation accuracy. Keep safety databases and trackers updated for audits and inspections. Draft clear narratives for adverse events to support regulatory submissions and study records. Prepare safety reports such as MedWatch and CIOMS forms accurately and promptly. Create and maintain study-specific SAE or AESI forms. Develop and update safety management plans and SOPs to align with GCP standards. Assist in training study teams on safety reporting procedures and timelines. Participate in setting up new safety databases and compiling safety data for reports and meetings. Perform SAE reconciliation and liaise with other departments. Support inspection readiness activities, including documentation for eTMF. Support the Medical Monitor in reviewing and developing safety-related documents. Inform the study team of safety issues and potential signals from data review. Minimum Requirements Education: Bachelor's degree in healthcare, science, or related field required; Master’s degree preferred. Certification and Licensing: Clinical research certification (e.g., ACRP, SOCRA) preferred. Experience: Minimum 1 year of experience with clinical trials involving drugs, biologics, or devices; experience as a clinical research monitor preferred. The University of Miami offers competitive salaries and a comprehensive benefits package, including medical, dental, tuition remission, and more. UHealth, the University of Miami Health System, provides leading-edge patient care supported by research and education at the Miller School of Medicine. Serving South Florida, Latin America, and the Caribbean, our physicians cover over 100 specialties with more than one million patient encounters annually. Our tradition of excellence is recognized worldwide for teaching, research, and patient care. Join us for a challenging and rewarding career. The University of Miami is an Equal Opportunity Employer. Females, minorities, protected veterans, and individuals with disabilities are encouraged to apply. Protected from discrimination by federal law. Click here for more information. Job Details: Full time | Staff | Pay Grade: A10 About Us The University of Miami aims to transform lives through education, research, innovation, and service. As a diverse and vibrant academic community, we are one of the top research universities and medical centers in the nation. Our 12 schools and colleges offer over 350 programs. Learn more at welcome.miami.edu/about-um . Rankings include No. 55 on U.S. News & World Report’s 2022 Best Colleges and No. 49 on the Wall Street Journal/Times Higher Education College Rankings. Bascom Palmer Eye Institute is ranked #1 in the USA, and Sylvester Comprehensive Cancer Center received NCI designation in 2019. We are recognized among Forbes' Best Employers and Best Employers for Women. With over 17,000 faculty and staff, we are committed to excellence, diversity, and community, driven by our core values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT). Our mission is to transform and impact lives worldwide. #J-18808-Ljbffr University of Miami

Job Tags

Full time, Temporary work, Second job, Worldwide,

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