University of Miami
Location
Miami, Florida
Coordinates the planning, implementation, and monitoring of clinical research studies from initiation to close-out. Manages participant recruitment, data collection, and regulatory documentation while ensuring adherence to safety protocols.
Requires a bachelor's degree in a relevant field and a minimum of 2 years of relevant experience. Candidates must possess strong communication skills, technical proficiency in office software, and the ability to adapt to changing research priorities.
Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders. This is a core job profile description and is not reflective of all duties that may be assigned to a specific position in each individual department. The above statements are intended to describe the general nature and primary responsibilities of this core job profile. Specific duties and tasks may vary based upon departmental needs. Other duties may be assigned to the above consistent with the knowledge, skills, and abilities required for the job. Department Specific Functions Establishes patient/participant screening procedures with Principal Investigator and obtains relevant medical information from patient clinic charts/medical records. Establishes/maintains contact with patients/participants, health care providers, community agencies, and study sponsors. Obtains informed consent from patients/study participants and documents the process in alignment with policies and procedures. Implements research protocols and monitors participant and study team adherence. Ability to handle multiple clinical trials with several principal investigators. Recruits patients referred by physicians, schedules study appointments, prepares for and conducts study visits in the clinic. Serves as back up study coordinator to other clinical trials. Processes and ships participant biological samples to central labs according to safety regulations. Collaborates with the research pharmacy to dispense study medication and maintain unmasked study records. Completes corrections/queries required at audits/monitor visits and takes action to correct deviations, as needed. Updates appropriate agencies (such as sponsors, IRB, etc.) regarding current status of research project. Enters data into electronic data capture system within specified timelines and meets sponsor’s data lock deadlines. Provides in-service education to study team members about research protocols. Maintains study regulatory files, including delegation of authority logs, training records, and sponsor correspondence. Maintains participant files, including informed consent forms, source documents, and participant compensation/reimbursement records. Prepares and submits annual continuing reviews to the Institutional Review Board (IRB). Notifies IRB of protocol amendments, safety reports, and reportable information in compliance with applicable regulations. Invoices sponsor and performs study account reconciliation with the research administration team. Travels to sponsored Investigator Meetings out of state, as needed. Flexibility to travel to all Bascom Palmer Eye Institute sites, as needed. 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.
Full time Employee Type: Staff The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation. The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride. The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings. Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019. The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022. With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe. The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
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