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

University of Miami•Miami, FL

12d•Onsite

About The Position

The Clinical Research Coordinator 1 serves as an entry-level clinical research professional that has a foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines.

Requirements

Bachelor’s degree in relevant field or equivalent
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.

Responsibilities

Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols.
Maintains enrollment procedures according to the protocol.
Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
Knows the contents and maintenance of study-specific clinical research regulatory binders.
Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
Adheres to University and unit-level policies and procedures and safeguards University assets.
Establishes patient/participant screening procedures with Principal Investigator and obtains relevant medical information from patient clinic charts/medical records.
Ability to handle multiple clinical trials with several principal investigators.
Serves as back up study coordinator to other clinical trials.
Obtains informed consent from patients/study participants and documents the process in alignment with policies and procedures.
Recruits patients referred by physicians, 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.
Establishes/maintains contact with patients/participants, health care providers, community agencies, and study sponsors.
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.
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.
Implements research protocols and monitors participant and study team adherence.
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.