Clinical Research Nurse 3

Rush University Medical Center - Chicago, IL

Full-time

Chicago, IL

Hospitals

About the position

Rush University Medical Center is seeking an expert research nurse who leads the provision of clinical care within the context of a clinical research study and helps develop studies and projects. This role may lead the most risky of trials including early phase trials (phase 0 & 1). The research nurse will lead subject recruitment, eligibility, informed consents, and protocol adherence. They will monitor research participants for changes in health status, including monitoring toxicities, assessing clinical response, and providing exemplary patient care while ensuring the protocol is conducted in a high-quality manner. The nurse will update clinical staff regarding patients' study medications or changes in status, educate clinical staff and physicians regarding the study, and provide oversight to a team of dedicated research nurses and/or coordinators. This position exemplifies the Rush mission, vision, and ICARE values and acts in accordance with Rush policies and procedures.

Responsibilities

• Provides nursing care to patients participating in clinical research studies, may include: standard of care procedures, research procedures, study medication administration and adherence assessments, adverse event assessment documentation, blood draw, EKG administration, and various clinical assessments.
• Creates and implements nursing plan of care in connection with study protocol.
• Utilizes clinical assessments to ensure patients receive follow-up care as needed.
• Communicates research-related information to patients, families, nursing and medical staff as necessary.
• Communicates participant health status changes to PI and clinical care staff.
• Educates the physicians and other clinical staff inpatient and/or outpatient on the study protocol and the plan of care for the research participant.
• Mentors less experienced research nurses or other staff.
• Collaborates with Research Compliance, Office of Research Affairs, Division/Department to develop orientation and ongoing education for research staff, nursing and PIs. Onboards new staff.
• Performs subject assessment, administers medication, and provides nursing support to perform diagnostic, therapeutic and surgical procedures.
• Schedules visits and ensures study related orders are completed for the visit. Including providing patient education regarding tests and/or procedures.
• Proactively identify potential issues and/or variances with study protocol regulatory issues.
• Maintains current knowledge of disease/disorder specific conditions and clinical research trends.
• Attends and participates in study specific training, conferences, and education.
• May present at professional conferences related to clinical research.
• Summarizes and shares relevant industry information during internal and external presentations and/or publications.
• May act as a nursing representative on the Protocol Review and Monitoring Committee, Data Safety Monitoring Board and other relevant committees.
• Adhere to attributable, eligible, contemporaneous, original and accurate (ALCOA) documentation standards.
• May develop standard operating procedures related to study protocols, policies and procedures, regulatory guidelines and regulations.
• Performs a root-cause analysis as it relates to patterns of protocol deviations.
• Assesses subject eligibility for inclusion in research protocols, e.g., pre-screening, screening and enrollment.
• Ensures study team is kept up-to-date on the protocol and safety reports received from the study sponsor.
• Maintains written and verbal communications on regular schedule with PI and other assigned contacts.
• Lead preparation activities for routine monitoring visits, audits, etc.
• May assist in planning new protocols and associated implementation.
• Defines and implements collection of metrics for compliance, accrual data and staff workload.
• Assists research leadership to implement program development initiatives, including complex and high-risk protocols as needed.
• Collaborates with PI, sponsor, medical monitor, compliance, staff, Office of Research Affairs and manager to identify and improve both routine and complex processes as it relates to the regulatory and operational aspects of a research study.
• May lead the development, implementation, and communication of process and procedures for data quality assurance and safety monitoring.
• Accountable to PI for protocol adherence. Ensures research team is performing activities within established protocols.
• Provides clinical direction to less experienced research and nursing staff.
• Responsible for daily management and direct supervision of assigned research staff, including performance feedback, providing training and mentorship.

Requirements

• Bachelor of Science in Nursing (BSN) or Master of Science in Nursing (MSN).
• Current IL RN license.
• Basic Life Support certification for Healthcare Professionals.
• Seven years of clinical nursing practice experience required.
• Relevant research certification (Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP).
• Demonstrate skills in mentoring clinical research professionals in Good Clinical Practices and/or Good Documentation Practices, human subjects protections, institutional, local, state and federal guidelines and regulations related to clinical research.
• Ability to communicate complex clinical and regulatory concepts in layperson language.
• Ability to build rapport with diverse patients and peers.
• Demonstrated problem-solving, critical decision makings and professional judgment.
• Strong organizational skills and attention to detail.
• Ability to work successfully both independently and in team settings.
• Flexible work hours and travel may be required.

Nice-to-haves

• Ten years of experience in clinical research with emphasis on interventional studies.
• Three years of team supervision.
• Clinical specialty certification as appropriate to study population.

Benefits

• Exceptional rewards and benefits as outlined on Rush benefits page.