Sr. Clinical Trials Nursing Specialist

Senior Clinical Trials Nursing Specialist

The job has deep knowledge and expertise within a Nursing specialty. Establishes plans for the safe distribution of medications. Uses specialized depth and breadth of experience in Healthcare issues to direct primary health care to patients, in collaboration with consulting physician and multidisciplinary health teams. This position requires strong Oncology Nurse Navigation (ONN) experience, extensive experience and expertise with clinical research, including regulatory compliance, and proven leadership capabilities. Our research program is one of the largest gynecologic oncology programs in the Midwest, with an average of 18-22 therapeutic Phase I-III trials open at all times. We seek a Senior Clinical Trials Nursing Specialist to provide direct and functional supervisory oversight of clinical trials nursing care across five UChicago Medicine Gynecologic Oncology sites. This position will work closely with the Section Chief, Clinical Nurse Manager, Clinical Trials Physician Lead, and departmental leadership to develop pathways and processes that optimize efficient trial initiation, patient enrollment, and safe, protocol-compliant care. The role includes performance management, systems optimization, quality auditing, data analytics, and strategic expansion of the clinical trials program.

Responsibilities

• Provides in-services on complex Phase I trial protocols (e.g. cell therapy infusions).
• Provides collaborative lead nursing support for ONNs at 5 clinical sites.
• Works with clinical trials program physician leadership and UCCCC Clinical Trials Support Office (CTSO) to increase trial accruals, shape trials program development.
• Supports development of clinical standard operating procedures (SOPs) for Gynecology Oncology ONNs and PAs.
• Coordinates clinical trial protocol in-service education for IVTH units at 4 sites (DCAM, Orland Park, Silver Cross, Crown Point).
• Leads work to standardize patient-facing chemotherapy and surgery education; works with program manager to facilitate and disseminate education tools via meetings and shared information platform.
• Acts as primary liaison to Hematology Oncology nurse educator, nursing Unit Based Council (UBC) and IVTH leadership at (4) infusion sites related to patient safety and workflow.
• Monitors and makes recommendations to RN workload evaluations.
• Maintains very limited direct patient care ONN clinic support.
• Partners in the coordination of new hire onboarding / training for Gynecologic Oncology Nurse Navigators.
• Improves education documentation processes /conducts compliance audits (QOPI standards).
• Provides functional oversight of clinical trials nursing care at five UChicago Medicine Gynecologic Oncology locations, including clinical trials onboarding, performance assessment of oncology nurse navigators supporting clinical trials patients, performance auditing, and management of data/analytics related to clinical trials growth.
• Leads clinical trials performance assessment and auditing processes for all licensed professionals caring for clinical research patients, ensuring protocol compliance, patient safety, and adherence to regulatory standards (e.g., QOPI) across five locations.
• Manages data collection, analytics, and reporting related to clinical trials growth, accrual metrics, and operational efficiency to support data-driven decision-making and continuous improvement in trial nursing care.
• Oversees clinical trials onboarding programs and ongoing competency development for nursing staff at five serving locations, partnering with Nurse Managers, CTSO, and site leadership to standardize best practices and mentorship.
• Works directly with the Clinical Trials Physician Lead and Section Chief to design and execute a strategic growth plan for clinical trials geographic deployment and expansion of relationships for investigator-initiated, government-sponsored, industry-sponsored, and collaborative clinical trials. Also responsible for leading UCCCC affiliate expansion of gynecologic oncology clinical research (i.e. Advent Health Shawnee Mission).
• Leads comprehensive or episodic health assessments. Solves complex problems in patient care and recommends appropriate treatments. Develops patient care plans within clinical nursing practice and medical care protocols and prepares patient health summaries.
• Collaborates with and provides expertise to nurses, patients, families, physicians, and community resources for coordination of patient care. Selects appropriate communications approach to achieve desired outcomes of patient care.
• Requires specialized depth of knowledge and skills for professional development. Interprets quality assurance issues on the unit, and recommends best practices. Provides expertise to staff on or off the unit for clinical skills.
• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

Certifications:

Basic Life Support (BLS) Certification - American Heart Association or Other, Certified Nurse Midwife (CNM) - State of Illinois, Neonatal Resuscitation Program (NRP) - American Academy of Pediatrics, Registered Nurse (RN) - State of Illinois

Preferred Qualifications

Education:

• Advanced Nursing degree (CNL, CNE, CNS strongly preferred).

Experience:

• Experience in solid tumor oncology and Gynecologic Oncology.
• Prior experience with enrolling and caring for patients on clinical trials.
• Specialized depth of knowledge in oncology care, clinical trials operations and regulatory compliance.

Licenses and Certifications:

• Oncology Nurse Certification by the Oncology Nursing Certification Corporation.
• Clinical Research Certification.

Preferred Competencies

• Ability to perform multiple concurrent tasks with occasional interruptions.
• Ability to exercise discretion and confidentiality while handling sensitive.
• Demonstrated patient facing clinical excellence, effective leadership and teaching skills.
• Strong interpersonal skills and the ability to work independently.
• Strong organizational skills.
• Demonstrated written and verbal communication skills and strong analytical skills.
• Problem-solving.
• Attention to detail.
• Strategic planning and change management skills.

Working Conditions

• Clinical and administrative office environments.
• Ability to stand and sit for extended periods of time.

Application Documents

• Resume (required)
• Cover Letter (required)

The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions. When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.