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The Department of Otolaryngology is currently seeking a full time Clinical Research Coordinator 1 to work in Miami, FL. The Clinical Research Coordinator provides professional level support for research clinical studies involving human subjects and assists in the design of studies, generation of databases, and update and maintenance of documentation. Moreover, the Clinical Research Coordinator develops, verifies, and implements procedures to accomplish research goals.
CORE JOB FUNCTIONS
1. Coordinates routine activities of clinical studies including data maintenance, grant expenditure adherence, project evaluation, meeting scheduling, and research subject interfacing. 2. Tracks medical reports and reviews regulatory documents to generate reports. 3. Serves as project liaison to other departments, outside organizations, government agencies, and product representatives. 4. Recruits patients into the study and reviews on a weekly basis the percentage recruited. 5. Reviews data collected and inserts into the study dataset. 6. Compares the data collected to the monitored phone calls for data quality assurance. 7. Evaluates and monitors timelines for studies and for each subject participant to comply with applicable protocols. 8. Prepares materials for the brochures and retaining letters and mails to appropriate members according to their time in the study. 9. Administers informed consent forms for patients on drug studies. 10. Maintains pool of study candidates and ensures their availability. 11. Coordinates the necessary testing for patient evaluations per physicians' orders and study protocol requirements. 12. 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
Experience:
Minimum 3 years of relevant experience
DEPARTMENT ADDENDUM
Department Specific Functions
1. Managing the Study
Independently performs chart review/pre-screening for eligibility and coordination of simple clinical research protocols.
Maintains all logs, including Velos entry according to UM and department SOPs.
Assists planning study timelines and schedules appointments and study visits.
Manages and organizes case report forms, source documents and research records.
Conducts data collection activities according to established operational procedures and timelines.
Assists in observing and informing the PI/supervisor in a timely manner of adverse events, including those reported by study participants.
Fully adheres to established procedures, policies, and standards in implementing clinical research protocols.
Adheres to continuous research quality improvement practices.
Maintains safety, environmental, and/or infection control standards throughout job duties.
Assists in entering research data into data collection forms and/or study databases.
Assists in conducting quality checks for data accuracy with data source records as assigned.
Increases understanding of and interpreting moderately complex clinical study designs, research protocols, and procedures.
Executes simple clinical research protocols and may assist CRA1/CRDS in fundamentals.
Exhibits increasingly sound judgment in planning/performing research protocols for optimal quality research.
2. Research Regulatory Compliance and Human Subject's Protection
Follows fundamentals of Good Clinical Practice (GCP) per E6 guidelines of the International Conference of Harmonization (ICH)
Follows the fundamentals of conducting clinical research under the appropriate federal and local regulations.
Follows the fundamental requirements for adverse event assessment, documentation, and reporting.
Follows the principals of informed consenting process and documentation.
Obtains study-specific clinical research protocol and research-related procedures training. Assists others in same.
Knows the contents and maintenance of study-specific clinical research regulatory binders.
Ensures and adheres to standards of protecting clinical research data and study participant private information according to HIPAA and regulatory privacy requirements.
Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
Participates in site visit and internal/external auditing activities as assigned.
Assures own adherence to safety and responsible conduct of research standards. Assist others in same.
Follows established policies, procedures, continuous research quality improvement practices, and safety, environmental, and/or infection control standards throughout research protocol, problem solving and following through about unanticipated occurrences.
3. Maintaining Study Continuity and Coordinating Logistics, Research Procedures, and Study Participants
Participates in pre-screening activities for study participant eligibility, maintaining enrollment procedures according to the protocol.
Observes, reports, and facilitates positive study participant responses, minimizing deviations.
Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
Performs testing and data collection activities according to established operational procedures and timelines.
Observes for deviations and takes action to minimize them. Reports deviations when they occur, addressing adverse events with supervision.
Shows increasing organizational skills to facilitate full adherence to timelines.
Continues to learn how to recognize and report logistical challenges in protocol implementation to the research team, assisting in resolving challenges.
Assists in identifying and developing data collection tools. Assists the CRA 1 in simple data tasks.
Performs quality checks for data accuracy, reports/follows-up with discrepancies.
Effectively collaborates with clinical services/departments to plan, implement, and evaluate study protocols.
4. Contributing to the Science
Adheres to standards of excellence in scientific methods applied to protocol implementation.
Learns and values the importance of quality research standards, identifies personal role in advancing them, and assists in helping others in same.
5. Professional Development
Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
Maintains CITI and Conflict of Interest (COI) certification and renewal as required.
Gains knowledge in medical research terminology.
Continues to gain proficiency in UM-specific research software needed to manage clinical research protocols.
Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards. Assists in helping others in same.
Participates in protocol-related training as required.
Performs other duties as assigned.
Knowledge, Skills and Attitudes:
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.
#ED-LI1
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
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