Clinical Research Nurse 2

Job Description

Job Description

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 patient eligibility, and coordinate all aspects of patient enrollment.
• Coordinate patient care activities across multidisciplinary teams to ensure seamless integration of research procedures into clinical care.
• Manage multiple clinical trials concurrently (ideally 10 or more), prioritizing tasks and maintaining high standards of accuracy and compliance.
• Use Clinical Trials Management Systems (CTMS) and other electronic tools to track study progress, patient visits, and regulatory documentation.
• Collaborate with hematology and oncology teams, particularly in classical hematology and lymphoma/myeloma disease areas, to support disease-specific research protocols.
• Engage in continuous professional development in clinical research nursing, staying current with evolving regulations, guidelines, and best practices.
• Perform other related duties as assigned to support the overall success of the clinical research program.

Essential Skills

• Active licensure as a Registered Nurse in the State of Connecticut or eligibility for Connecticut RN licensure.
• Minimum of three years of nursing experience in a hospital, clinic, or research setting, or equivalent clinical research nursing experience.
• Minimum of two years of clinical research nursing experience strongly preferred, with a focus on oncology or hematology trials.
• Demonstrated experience managing multiple clinical trials simultaneously, ideally 10 or more at once.
• Strong clinical research background with proven study coordination experience, including patient screening, eligibility assessment, consent, and enrollment.
• Experience in pre‑screening patients for clinical trial eligibility, particularly in oncology and hematology settings.
• Proficiency in Good Clinical Practice (GCP) and working knowledge of ICH/GCP guidelines and applicable federal regulations.
• Knowledge of Food and Drug Administration (FDA) regulations and other relevant regulatory frameworks governing clinical trials.
• Experience with Clinical Trials Management Systems (CTMS) for tracking study activities and patient data.
• Strong clinical, analytical, and organizational skills with demonstrated research nursing ability.
• Proven ability to draft, proofread, and document complex clinical and research materials with meticulous attention to detail.
• Strong computer skills, including proficiency with Microsoft Office applications such as Word, Excel, and PowerPoint.
• Ability to interpret complex clinical trial protocols and apply them accurately in clinical practice.
• Proven ability to evaluate and assess patient suitability for inclusion in studies and to determine eligibility based on protocol criteria.
• Demonstrated ability to obtain informed consent in compliance with ethical and regulatory standards.
• Excellent time management and organizational skills with the ability to multi‑task and remain focused in a fast‑paced environment.
• Ability to maintain confidentiality and handle sensitive patient and study information appropriately.
• Strong interpersonal and communication skills, with the ability to collaborate effectively with multidisciplinary clinical and research teams.
• Ability to coordinate patient care within a structured, protocol‑driven environment.
• Comfort working in a patient‑focused academic medical center or cancer research setting.

Additional Skills & Qualifications

• Hematology experience, particularly in classical hematology, is highly preferred for roles focused on this disease area.
• Oncology experience is preferred for lymphoma/myeloma roles, though disease‑specific knowledge can be taught when strong research experience is present.
• ACRP or SOCRA (or equivalent) clinical research certification preferred.
• Oncology Nursing Society (ONS) certification preferred.
• Experience working with hematology and lymphoma/myeloma patient populations.
• Familiarity with clinical trial workflows in academic medical centers and cancer centers.
• Experience collaborating with clinical research associates (CRAs), sponsors, and regulatory monitors.
• Ability to develop and deliver training materials, in‑services, and protocol‑specific educational tools for clinical staff.
• Demonstrated ability to thrive in a collaborative, mission‑driven research environment focused on advancing cancer treatment.

Work Environment

This role is based in an academic medical center and cancer research setting, working within collaborative, multidisciplinary clinical research teams. The position typically requires four days per week on site, with occasional need for a fifth day depending on workload, and a standard 40‑hour work week. Start and end times may vary based on the volume of work and patient scheduling, so flexibility is expected. The environment is patient‑focused and highly structured, with rigorous protocols and regulatory oversight guiding daily activities. Clinical Research Nurses work closely with physicians, pharmacists, coordinators, and other healthcare professionals in a mission‑driven culture centered on advancing cancer care through cutting‑edge clinical trials. Some roles may require travel between nearby clinical sites, including locations such as New Haven and Orange, CT. The setting emphasizes professionalism, adherence to research and clinical standards, and a strong commitment to patient safety and ethical conduct.

This is a Contract to Hire position based out of New Haven, CT.

The pay range for this position is $50.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in New Haven,CT.

This position is anticipated to close on Aug 17, 2026.

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