Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet .
The Bascom Palmer Eye Institute is currently seeking a full time Clinical Research Coordinator 2 to work at the McKnight Vision Research Center in Miami.
The Clinical Research Coordinator 2 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.
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.
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 cultural competency 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.
Department Specific Functions
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…