Clinical Research Nurse 2

Job Title:

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

Job Description

The Clinical Research Nurse II provides specialized research nursing services for patients enrolled in oncology and hematology clinical trials, ensuring the safe, compliant, and efficient conduct of moderately to highly complex protocols. This role combines direct patient care with advanced study coordination responsibilities, including patient screening, eligibility assessment, enrollment, and ongoing management of study-related clinical activities. The Clinical Research Nurse II serves as a key member of an academic cancer research team, supporting cutting‑edge clinical trials and contributing to the advancement of cancer treatment.

Responsibilities

+ 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.

+ Plan, track, and oversee clinical activities for study participants to ensure all procedures are conducted in accordance with approved protocols and regulatory requirements.

+ Assist with study feasibility reviews by evaluating protocol requirements, patient population, and operational considerations.

+ Adhere strictly to study protocols, maintain accurate and complete documentation, recruit and consent study participants, and ensure all activities comply with ICH/GCP guidelines, federal regulations, and institutional and sponsor requirements.

+ Identify instances of noncompliance and protocol deviations, document them accurately, and report them to the appropriate parties in a timely manner.

+ 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 orders for routing to investigators for approval and signature, ensuring timely and accurate execution of study-related orders.

+ Support Principal Investigator oversight by providing regular updates on protocol issues and obtaining required signatures and clinical significance assessments on laboratory reports, ECGs, adverse events, and other key documents.

+ Develop and deliver training for new protocols, including creating training materials, protocol-specific toolkits, and nursing in‑service presentations, and determining appropriate training methods, timing, and frequency.

+ Perform direct patient care and assessments, both clinical and non‑clinical, such as electrocardiograms and administration of research instruments in accordance with study protocols.

+ Advocate for patients and families by maintaining the integrity of the clinical research study and serving as a clinical resource for triaging and addressing research-related inquiries from institutional websites and professional presentations.

+ Provide patient and family education on study participation, including medication dosing, administration, potential side effects, and protocol requirements to support understanding and adherence.

+ Serve as a front‑line medical resource in interpreting protocols for medical and nursing staff, particularly regarding dosing, medications, 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 ensure 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.

+ Consent patients for clinical trials, ensuring informed consent is obtained and documented appropriately.

+ Document adverse events and serious adverse events thoroughly and accurately, and communicate relevant information to investigators and sponsors.

+ Collaborate with pharmacy to build and manage treatment plans that align with protocol requirements and patient safety considerations.

+ Interpret complex clinical trial protocols, evaluate and assess subjects' suitability for inclusion, determine…