Clinical Research Coordinator 1 Full Time Bascom Palmer Eye Institute

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The University of Miami, Bascom Palmer Eye Institute has an exciting full time opportunity for a Clinical Research Coordinator 1 to work in the Department of Research.
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. The incumbent is responsible for simple clinical research protocols and timelines.

CORE JOB FUNCTIONS

• 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.

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.

CORE QUALIFICATIONS
Education:
Bachelor’s degree in relevant field required

Experience:
Minimum 1 year of relevant experience required

Certification and Licensing:
Refer to department description for applicable certification requirements

Knowledge, Skills and Abilities:

• Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.

• Teamwork: Ability to work collaboratively with others and contribute to a team environment.

• Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.

• Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

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 corrections/queries required at audits/monitor visits and takes action to correct deviations, as needed.  

• Establishes/maintains contact with