Clinical Research Coordinator

Position: Clinical Research Coordinator 1

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Clinical Research Coordinator 1

The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Clinical Research Coordinator 1 to work at the UHealth Medical Campus. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities 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.

Core Responsibilities

• 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.

Department Specific Functions

This Clinical Research Coordinator position is to work in the Neurology Department, Comprehensive Center for Brain Health, at the University of Miami School of Medicine. This position requires extensive coordination of several research studies for three principal investigators, and requires experience with patient interaction/evaluation and with the regulatory aspects of clinical research. This position is responsible for assisting the principal investigators and other research staff in coordinating federal and/or industry sponsored research studies in Neurology.

• Assist the PIs in developing UM protocols for submission to IRB, including but not limited to the submission of required documentation to the UM/JMH IRB to ensure successful approval of research protocols. Maintenance of any reporting and other requirements by the IRB.
• Administer informed consent forms for patients on drug studies.
• Develop, review and submit required documentation to the UM/JMH IRB to ensure successful approval of research protocols. Maintain any reports and other requirements by the IRB.
• Interact with various sponsoring agencies and their representatives, on issues regarding on-going protocols requiring occasional visits to supporting agencies and national meetings. Relate information back to the Division.
• Coordinate patient recruitment and screening procedures in inpatient and outpatient settings. Obtain necessary medical records, schedule patients for pre-study screening, and maintain a study patient list.
• Coordinate research related activities between departments to accomplish goals of studies
• Develop and manage the following procedures as they pertain to research studies and patients:
• Perform necessary study evaluations
• Complete patient data forms; collect results from outside laboratories, etc. and complete data into case report forms.
• Maintain pool of study candidates and ensure their availability.
• Contact patients by telephone as required by the PI for clinical follow-up for requirements and adherence to research protocols.
• Complete the medical chart and log-in of patient's vital signs, including weight, temperature, pulse rate, respiratory rate and blood pressure into case reports.
• Collect vital signs, lab specimens (blood, urine, etc.)
• Prepare lab samples for shipping
• Coordinate the necessary testing for patient evaluations per physician's orders and study protocol requirements.
• . Process and ship lab specimens to central lab as required by protocol and maintain updated study kits and supplies and maintain general laboratory supplies.
• Offer assistance and provide information to help patients with…