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. 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.

• Ensure compliance with each study’s protocol by providing through review and documentation at each study visit
• Participate in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements
• Perform medical tests, including but not limited to, vital signs, lab draws and processing, and electrocardiograms
• Administer investigational medication and perform patient assessments during clinic visits to determine presence of side effects; notify Principal Investigator of findings/issues
• Provide patient education and medical information to study participants to ensure understanding of proper medication dosage, administration, and disease treatment
• Document medical data in patient chart to capture protocol requirements
• Ensure site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
• Develop accurate source materials to ensure compliance from all site staff
• Provide accurate and timely data collection, documentation, entry, and reporting in both sponsors, Clinical Research leadership, and overseeing IRB, as indicated
• Ensure appropriate training and credentialing for assigned protocols and associated staff
• Support the regulatory staff in the maintenance of regulatory documents
• Communicate and collaborate specific study requirements to the search team, including internal and external parties, sponsors, monitors, PI, and study participants
• Ensure compliance with research protocols through participation in ongoing quality control audits, including maintaining ongoing investigational drug accountability
• 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

• Demonstrate excellent customer service
• Always promote 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
• Act as liaison between all involved clinical areas and staff of the protocol requirements
• Work collaboratively with investigators, sub investigators, referring physicians, other clinical research nurses, and hospital staff
• Provide education for patients and families regarding the protocol, including the disease process, plan of care, symptom awareness, and the need to report adverse events
• Provide in service education to the clinical staff of the hospitals (pharmacy, nursing, etc.) related to investigational drugs, devices, or procedures, including physiological effects, drug interactions, side effects, nursing care considerations, etc.
• Communicate serious adverse events to all appropriate sources
• Accountable to the Manager of Cardiovascular Research
• Represent My Michigan Health as a professional, high-quality clinical site
• Prepare, coordinate, and participate in on-site monitor visits
• Analyze protocol and assist in the creation of source documents
• Coordinate activities related to billing, notification of appropriate departments, lab orders, etc.
• Understand and contribute to the functional unit plan goals and objectives that align with the organization’s strategic plan
• Follow patients and complete post-hospital follow ups, including clinical assessments
• Perform blood draws and basic lab tests as required by the protocol
• Coordinate and provide patient care and follow up to research patients as indicated per…