Job Description
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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 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.
This is a core job profile description and is not reflective of all duties that may be assigned to a specific position in each individual department. The above statements are intended to describe the general nature and primary responsibilities of this core job profile. Specific duties and tasks may vary based upon departmental needs. Other duties may be assigned to the above consistent with the knowledge, skills, and abilities required for the job.
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status: Full time
Employee Type: Staff
Pay Grade: A8
Job Tags
Full time, Temporary work, Work at office, Local area, Worldwide,