Clinical Research Coordinator V
About The Position
Working under the direction of the clinical Principal Investigators (PI), in the Department of Surgical Oncology, the Clinical Research Coordinator V is responsible for the enrollment, active accrual, implementation, facilitation and coordination of daily clinical trials activities and plays a critical role in the conduct of multiple clinical research studies. The Clinical Research Coordinator V works collaboratively with investigators, multidisciplinary clinical entities, sponsors, monitors and regulatory entities to ensure the safety of study participants, the efficiency of study operations and the timely completion of studies. The Clinical Research Coordinator V is also expected to have an understanding of how regulatory, financial and oversight entities work together in the management of clinical research.
Requirements
- Bachelor's degree in a related field and two (2) or more years of relevant research experience, or an equivalent combination of education and work experience.
Responsibilities
- Coordinates the activation, implementation, enrollment, accrual, and maintenance of multiple research protocols.
- Ensures assigned studies are conducted in accordance with the University of Louisville Institutional Review Board (UL IRB), Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP).
- Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices and procedures.
- Assists investigators and clinical staff in the identification, recruitment, screening and enrollment of eligible study participants.
- Develops accurate source materials and ensures compliance from site staff.
- Provides accurate and timely data collection, documentation, data entry and reporting in accordance with site SOPs and applicable regulations.
- Interfaces with research participants to support efforts to determine eligibility and consent.
- Communicates and collaborates specific study requirements to study participants, the research team (PI, SI, data managers, regulatory, financial), the multidisciplinary clinical management team and oversight entities (IRB, sponsors, monitors).
- Provides ongoing quality control of study operations including maintenance of accountability logs.
Benefits
- Compensation will be commensurate to candidate experience.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
