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|Clinical Research Coordinator|
Company: University of Miami Health System
Location: Miami, FL
Employment Type: Full Time
Date Posted: 09/18/2021
Expire Date: 11/18/2021
Job Categories: Science
Clinical Research Coordinator|
The Miami Transplant Institute is currently seeking a full time Clinical Research Coordinator. The incumbent in this position serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibiliti
es in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties, and assumes responsibility for simple clinical research protocols and timelines. Provides professional level support for research studies. Implements research protocol and monitors participant adherence to protocol. Establishes patient/participant screening procedures. Determines data to be collected and develops forms for collections/summarizing data. Establishes and maintains contact with patient/participants, health care providers, community agencies, study sponsors.
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 timelin
es, 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 rese
arch, continuing education, and research competencies. Adheres to University and unit-level policies and procedures and safeguards University assets.
Provides professional level support for research studies and assists in the design of studies.
Develops, verifies and implements procedures to accomplish research goals.
Implements research protocol and monitors participant adherence to protocol.
Verifies accuracy of research data and monitors data quality control.
Prepares and submits annual reviews to the Institutional Review Board (IRB). Maintains consent forms and sponsor correspondences. Notifies IRB of protocol amendments, safety reports and serious adverse events, etc. in compliance with applicable regulations.
Establishes patient/participant screening procedures with Principal Investigator and obtains relevant medical information from patient clinic charts/medical records. />
Maintains logs/progress reports to track both currently enrolled as well as follow-up patients/participants. Maintains drug accountability records for study drugs.
Determines data to be collected and develops forms for collecting/summarizing data.
Maintains and assists clinical research computer database and enters data onto case reports and/or into database as appropriate. Ensures data integrity and consistency in computer database and written records.
Completes corrections/queries required at audits/monitor visits and takes action to correct deviations as needed.
Establishes/maintains contact with patient/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 staff and patients/participants about research protocols.
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.
Bachelorís degree in relevant field required
Minimum 1 year of relevant experience