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GENERAL SUMMARY/ OVERVIEW STATEMENT:
Under the general direction of the Clinical Program Manager for the Division of Transplantation, the Clinical Research Coordinator II assists with the screening, recruitment of study patients, and implementation of study procedures. The Coordinator will obtain informed consent once study patients have been identified and educated about the study. Management of patients occurs under Clinical Research Manager and general physician supervision. Patient data is collected from numerous sources including clinical chemistry lab, radiology, and other patient records related to specific protocols and put in research study databases.
Collaborates with supervisor to create and maintain a database of clinical protocol data. The Coordinator will be a resource for teaching other personnel about such databases. Carries out a wide range of moderate to complex data management functions with a full understanding of the principles underlying the choice and use of statistical tests; responsible for creation of graphics/slides for manuscripts and oral presentations. Collaborates with supervisor in writing and editing material for publication.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Coordinates multiple (up to 5) concurrent clinical research studies, with responsibilities including:
1. Recruitment/Enrollment – In conjunction with Clinical Research RN and various physician investigators in the Division of Transplant, develops and implements study recruitment strategies and procedures:
2. Regulatory Compliance – With supervision from the PI and/or Clinical Research Manager, R.N., develops and maintains protocol specific documents, IRB amendments and reviews, and regulatory report submissions.. Duties include:
3. Data Management – Obtains and organizes patient data from medical records, physicians, etc., following HIPAA guidelines:
4. General Office & Laboratory Support:
5. Assumes additional administrative and clinical research tasks, as needed.
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
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