Clinical Research Coordinator 2 - Full Time - Bascom Palmer Eye Institute, Miami

Benefits

Qualifications

• •Bachelor’s degree in relevant field
• •Minimum 2 years 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
• •5 more items(s)

Responsibilities

• •The Clinical Research Coordinator 2 (A) serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies
• •This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines
• •The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel
• •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
• •Collects, 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
• •Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations
• •Assists in implementing protocol amendments under direct supervision of the Principal Investigator
• •Assists with study orientation and protocol related in-services to research team and clinical staff
• •Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule
• •Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments
• •Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews
• •Adheres to guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc
• •Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies
• •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
• •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
• •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
• •36 more items(s)