Job Description

Clinical Research Nurse II (CRN II) – Hematology / Lymphoma / MyelomaThe 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.Responsibilities include: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.Essential Skills include: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 demonstrated ability to manage complex oncology or hematology trials.Comfort and proven experience managing multiple clinical trials simultaneously, ideally 10 or more at once.Strong clinical research background, with research experience prioritized over disease-specific experience.Excellent clinical, analytical, and organizational skills, with demonstrated research nursing ability.Proven ability to draft, proofread, and document complex clinical and research information with meticulous attention to detail.Strong computer skills, including proficiency with Microsoft Office programs such as Word, Excel, and PowerPoint.Proven ability to interpret complex clinical trial protocols, evaluate and assess subject suitability, obtain informed consent, determine patient eligibility, and coordinate patient enrollment.Knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations governing clinical research.Experience with Clinical Trials Management Systems (CTMS) and related research data systems.Proven ability to multi-task, maintain confidentiality, and remain focused in a fast-paced academic medical environment.Excellent time management and organizational skills, with the ability to prioritize and manage competing study demands.Strong interpersonal and communication skills, with the ability to work effectively with patients, families, investigators, coordinators, pharmacy, and multidisciplinary clinical teams.Ability to coordinate patient care in alignment with protocol requirements and clinical standards.Hematology experience highly preferred for the Classical Hematology focus.Strong clinical research experience essential for both Classical Hematology and Lymphoma/Myeloma focuses.Additional Skills & Qualifications include:Oncology experience preferred for the Lymphoma/Myeloma focus; disease-specific knowledge can be taught if research experience is strong.Experience in classical hematology, lymphoma, and myeloma clinical trials is highly beneficial.Certification through ACRP, SOCRA, or an equivalent professional research organization preferred.Oncology Nursing Society (ONS) certification preferred.Experience with adverse event and serious adverse event documentation and reporting.Familiarity with building treatment plans in collaboration with pharmacy and clinical research teams.Experience working within academic medical centers or cancer research settings.Background or exposure to CRA functions, CTMS platforms, and oncology-specific research systems.Ability to develop and deliver training materials, protocol-specific toolkits, and nursing in-service presentations.Demonstrated commitment to patient advocacy and ethical conduct of clinical research.Work Environment:This position is based in an academic medical center and cancer research setting, working within collaborative, multidisciplinary clinical research teams focused on hematology and oncology. The role typically requires four days per week on site, and occasionally five days, with a 40-hour work week. Start and end times may vary based on workload and patient scheduling, so candidates should be flexible in managing their hours. The environment is patient-focused with structured protocols, rigorous regulatory oversight, and exposure to cutting-edge clinical trials. The culture is professional, collaborative, and highly mission-driven, emphasizing the advancement of cancer treatment through high-quality research. The role may require travel between New Haven and Orange, Connecticut, depending on study and clinic needs, and involves regular use of electronic medical records, CTMS platforms, and standard office and clinical equipment within a modern academic research facility.Job Type & Location:This is a Contract to Hire position based out of New Haven, CT.Pay and Benefits:The pay range for this position is $50.00 - $55.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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)

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