Clinical Research Coordinator 1 Full Time Bascom Palmer Eye Institute Miami, FL

Full time opportunity for a Clinical Research Coordinator 1 in Miami, Florida. Core Job Functions Perform chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintain enrollment procedures according to the protocol. Coordinate routine activities of clinical studies including data collection and maintenance, planning study timelines, scheduling appointments and study visits, meeting scheduling, and project evaluation. Perform moderate to complex research tests/experiments and adapt procedures for quality improvement under supervision. Understand and follow technical instructions for operating clinical research equipment, problem solve when operational failures occur. Assist in observing and informing the PI/supervisor of adverse events, including those reported by study participants. Address adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study. Identify, report, and help problem solve protocol deviations and unanticipated occurrences. Follow the appropriate fundamental requirements of all international, national, and local regulatory bodies. Know the contents and maintenance of study-specific clinical research regulatory binders. Maintain requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Adhere to University and unit-level policies and procedures and safeguard University assets. 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. Core Qualifications Education: Bachelor’s degree in relevant field or equivalent. Experience: Minimum 1 year of relevant experience. Skill in completing assignments accurately and with attention to detail. Ability to analyze, organize and prioritize work under pressure while meeting deadlines. Ability to process and handle confidential information with discretion. Ability to work evenings, nights, and weekends as necessary. Commitment to the University’s core values. Ability to work independently and/or in a collaborative environment. Department Addendum Establish patient/participant screening procedures with Principal Investigator and obtain relevant medical information from patient clinic charts/medical records. Handle multiple clinical trials with several principal investigators. Serve as back up study coordinator to other clinical trials. Obtain informed consent from patients/study participants and document the process in alignment with policies and procedures. Recruit patients referred by physicians, schedule study appointments, prepare for and conduct study visits in the clinic. Process and ship participant biological samples to central labs according to safety regulations. Collaborate with the research pharmacy to dispense study medication and maintain unmasked study records. Complete corrections/queries required at audits/monitor visits and take action to correct deviations, as needed. Establish/Maintain contact with patients/participants, health care providers, community agencies, and study sponsors. Update appropriate agencies (such as sponsors, IRB, etc.) regarding current status of research project. Provide in-service education to study team members about research protocols. Enter data into electronic data capture system within specified timelines and meet sponsor’s data lock deadlines. Maintain study regulatory files, including delegation of authority logs, training records, and sponsor correspondence. Maintain participant files, including informed consent forms, source documents, and participant compensation/reimbursement records. Prepare and submit annual continuing reviews to the Institutional Review Board (IRB). Notify IRB of protocol amendments, safety reports, and reportable information in compliance with applicable regulations. Implement research protocols and monitor participant and study team adherence. Invoice sponsor and perform study account reconciliation with the research administration team. Travel 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. The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Job Status: Full time Employee Type: Staff #J-18808-Ljbffr Dormont Manufacturing Co