Clinical Research Nurse

Job Title:

Clinical Research Nurse II (CRN II) – Hematology / Lymphoma / Myeloma

The Clinical Research Nurse II (CRN II) provides specialized research nursing services to patients participating in oncology and hematology clinical trials, ensuring the safe, compliant, efficient, and effective conduct of moderately to highly complex protocols. This role combines direct patient care with comprehensive study coordination, including planning, tracking, and executing all clinical trial activities in accordance with approved protocols and regulatory requirements.

The CRN II works within an academic cancer research setting, supporting classical hematology and lymphoma/myeloma studies while contributing to the advancement of cancer treatment.

• Coordinate, implement, and evaluate all aspects of clinical trial conduct, including study initiation, execution and maintenance, completion, and administration for moderately to highly complex protocols.
• Assist with study feasibility reviews to determine the practicality and resource requirements of proposed clinical trials.
• Adhere strictly to study protocols, maintain accurate and complete documentation, recruit and consent study participants, and ensure all regulatory and protocol requirements are met in accordance with ICH/GCP, federal regulations, and institutional and sponsor guidelines.
• Screen patients, determine eligibility, manage registration, and track protocol and subject milestones throughout the course of each study.
• Identify instances of noncompliance and protocol deviations, and promptly report these to the appropriate parties in line with regulatory and institutional standards.
• Build, review, and approve accurate and complete order sets to ensure compliance with individual research protocols, including reviewing Beacon order sets with clinical research coordinators in anticipation of upcoming clinic visits.
• Pend clinical orders for routing to investigators for review, approval, and signature, ensuring timely and accurate execution of study-related care.
• Support Principal Investigator oversight by providing updates on protocol issues and obtaining required signatures and clinical significance on laboratory reports, ECGs, adverse event documentation, and other study-related documents.
• Develop and participate in the delivery of training for new protocols, including creating training materials, protocol-specific toolkits, nursing in-service presentations, and other educational resources, and determining appropriate training methods, timing, and frequency.
• Perform direct patient care and clinical and non-clinical assessments, including electrocardiograms and administration of research instruments, in accordance with protocol requirements.
• Advocate for patients and families by maintaining the integrity of clinical research studies and serving as a clinical resource for triaging and addressing research-related inquiries originating from institutional websites and professional presentations.
• Provide patient and family education on study participation, including medication dosage, administration, potential side effects, and other relevant clinical information to support understanding and adherence.
• Serve as the front-line medical resource in interpreting protocols for medical and nursing staff, particularly regarding medication dosing and safety issues related to administration of study drugs or treatments.
• Participate in monitoring visits and external audits, including sponsor and regulatory agency (e.g., FDA) reviews, to facilitate smooth processes and positive outcomes.
• Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations in accordance with regulatory and institutional requirements.
• Manage multiple clinical trials concurrently, often 10 or more, ensuring high-quality coordination, documentation, and patient care across all assigned studies.
• Collaborate closely with pharmacy to build treatment plans, align medication orders with protocol requirements, and support safe and accurate drug administration.
• Coordinate patient care across multidisciplinary teams, ensuring that clinical needs, protocol requirements, and visit schedules are aligned and well communicated.
• Maintain confidentiality and remain focused in a fast-paced environment, using strong time management and organizational skills to prioritize competing demands.
• Perform other related duties as assigned to support the broader clinical research mission.

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