Clinical Research Coordinator 2 (Full Time) - Ophthalmology, BPEI - Miami, FL

Core Job Functions

• Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
• Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
• Collections, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
• Maintains study binders and filings according to protocol requirements, UM and department policy.
• Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
• 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.
• Travels to sponsored Investigator Meetings out of state, as needed.

Department Specific Functions

• Establishes patient/participant screening procedures with Principal Investigator and obtains relevant medical information from patient clinic charts/medical records.
• Serves as backup study coordinator to other clinical trials.
• Obtains informed consent from patients/study participants and documents the process in alignment with policies and procedures.
• Schedules study appointments, prepares for and conducts study visits in the clinic.
• 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.
• Provides in-service education to study team members about research protocols.
• Enters data into electronic data capture system within specified timelines and meets sponsor’s data lock deadlines.
• 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.
• Implements research protocols and monitors participant and study team adherence.
• Invoices sponsor and performs study account reconciliation with the research administration team.

Qualifications

• Bachelor’s degree in relevant field
• Minimum 2 years of relevant experience
• Skills 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

Pay

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

Schedule

The University of Miami offers a flexible schedule to accommodate the needs of the employee and the department.