SUMMARY: Coordinates, facilitates and monitors the implementation of all group research protocols being conducted in accordance with departmental policy, institutional policy, sponsor/protocol requirements, and FDA regulations. Provides, manages and coordinates care for patients participating in a clinical trial and their families, and ensures compliance with written protocols. RESPONSIBILITIES: Coordinate, implement and monitor clinical trials. Maintain familiarity with all aspects of active study protocols being conducted. Educate nursing, pharmacy and clerical staff about new protocols or amendment implementation and their roles in the implementation. Assist investigators in the proper conduct of all research protocols being conducted by the department in accordance with departmental policy, institutional policy, sponsor/protocol requirements and FDA regulations. Assist in the preparation review and verification of research-related documents intended for submission to sponsors, CROs, Clinical Investigation Committee, and/or the FDA. Demonstrate knowledge of good clinical practices for clinical research, protection of human subjects in research practices and research study management. Keep up-to-date knowledge of good clinical practices for clinical research and the latest research innovations. Coordinate and work collaboratively with clinical providers and nurses in patient subject recruitment, consenting, record maintenance and research sample acquisition and transportation. Retrieve non-invasive research specimens (e.g., nasal wash, phlebotomy) and assist physician or advanced practitioner in clinical research procedures (e.g., tympanocentesis in ambulatory setting). Ensure study data are collected accurately, and maintained in an orderly and easily retrievable manner. Maintain appropriate job and profession-specific certifications and credentials. Travel between local research sites
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Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed