Clinical Research Nurse RN

Summary

Clinical Research Nursing is the specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity of the research protocol (ANA, 2016). The Clinical Research Nurse is responsible for human subject protection, care coordination and continuity, contribution to clinical science, clinical practice and study management (IACRN, 2012). My Michigan Clinical Research Nurses work within a dedicated Research Department as a part of the health system focused primarily on clinical trials in multiple specialty areas.

Clinical trials may include pharmaceutical and device trials and other research projects directly related to patient treatment or care. The Clinical Research Nurse works under the guidance and supervision of the Principal Investigator, ensures the integrity and quality of clinical trials are maintained and conducted with federal, state, and local regulations, IRB board approvals, and My Michigan Health policies and procedures.

• (50%)* – Providing Direct Patient Care to Research Study Participants
• Ensure compliance with each study’s protocol by providing through review and documentation at each study visit
• Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements
• Performs medical tests, including but not limited to, vital signs, lab draws and processing, and electrocardiograms
• Administers investigational medication and performs patient assessments during clinic visits to determine presence of side effects; notifies Principal Investigator of findings/issues
• Provides patient education and medical information to study participants to ensure understanding of proper medication dosage, administration, and disease treatment
• Documents medical data in patient chart to capture protocol requirements
• (40%)* As a study coordinator, ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office of Research Protections (OHRP ), and Good Clinical Practice (GCP) guidelines
• Ensure site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
• Develops accurate source materials to ensure compliance from all site staff
• Provides accurate and timely data collection, documentation, entry, and reporting in both sponsors, Clinical Research leadership, and overseeing IRB, as indicated
• Ensures appropriate training and credentialing for assigned protocols and associated staff
• Supports the regulatory staff in the maintenance of regulatory documents
• Communicates and collaborates specific study requirements to the search team, including internal and external parties, sponsors, monitors, PI, and study participants
• Ensures compliance with research protocols through participation in ongoing quality control audits, including maintaining ongoing investigational drug accountability
• (10%)* – Complete required professional development and compliance training activities required by My Michigan Health and as needed for the position.
• Maintain Good Clinical Practice, IATA, and other training as required
• Complete Annual Compliance Modules for position
• Participate as a part of the research team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
• Occasional travel to attend sponsor study training meetings
• On-call for weekends/evenings – rotated among all study coordinators
• – based on FTE allocation
• OTHER
  
  DUTIES AND RESPONSIBILITIES:
  
  
• Demonstrate excellent customer service.
• Always promotes subject safety.
• Contribute to the My Michigan Health organization targets for patient satisfaction and net operating margin.
• Follow ALCOA principles for research documentation.
• Establish effective working relationships with participants, families, physicians, physician office staff, hospital staff, pharmaceutical company representatives, and research related visitors.
• Acts as liaison between all involved clinical areas and staff of the protocol requirements.
• Work…