Clinical Research Coordinator 2 (A) Full Time Bascom Palmer Eye Institute 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 requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
• Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.

Core Qualifications

• Education: Bachelor’s degree in relevant field required or equivalent.
• Experience: Minimum 2 Years Of Relevant Experience Required.
• Certification and Licensing: Refer To Department Description For Applicable Certification Requirements.
• Knowledge, Skills and Abilities: Learning Agility, Teamwork, Technical Proficiency, Communication.

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.
• 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.

Pay

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

Schedule

Full time Employee Type: Staff