Clinical Research Coordinator V - R104322

at  University of Louisville

MINIMUM REQUIREMENTS:

Bachelor’s degree in a related field and three (3) or more years of relevant research experience, or an equivalent combination of education and work experience. Grade 5E

JOB SUMMARY

Working under the direction of the clinical Principal Investigators (PI), 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.�

PREFERRED QUALIFICATIONS

• Bachelor’s degree in a scientific, informatics or health related field.�A minimum of 2 years’ work related experience in a research, oncology or surgery
• Certification in research (CCRC), oncology (OCN) or surgery (CNOR).
• Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations, and an understanding of research procedures and the ability to function independently.
• Completion of CITI training (GCP, Human Subject Protection) and IATA shipping training
• American Heart Association Basic Life Support.
• Prior laboratory experience including phlebotomy/venipuncture, sample processing and sample shipment.

• 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.
• Facilitates and documents the safe dispense and administration of investigational agents.
• Facilitates and documents the safe use of investigational devices.
• Reviews laboratory and clinical procedures including regular evaluations of protocol compliance.
• Conducts basic lab duties including procurement (including venipuncture), centrifuging, alloquoting, storage and shipment of study specimens.
• Immunizations according to CDC guidelines and facility policies.��Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.
• Must be available to respond to off hour (evening, nights, weekend) research needs and inquiries.