Clinical Research Nurse II
hace 3 días
New Haven
Job Description Job Title: Clinical Research Nurse II – Oncology Clinical Trials Job Description The Clinical Research Nurse II provides specialized research nursing services to patients participating in oncology clinical trials in an academic cancer center setting. This role combines direct patient care with the coordination and management of moderately to highly complex clinical research protocols, ensuring that all activities are conducted safely, efficiently, and in full compliance with regulatory, institutional, and protocol requirements. The Clinical Research Nurse II plans, tracks, and oversees all clinical trial activities for assigned studies, including patient screening, eligibility determination, registration, and ongoing protocol milestones, while serving as a key clinical resource for patients, families, investigators, and the research team. 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 oncology protocols., • Assist with feasibility reviews for new studies by evaluating protocol requirements, operational needs, and potential patient populations., • Adhere strictly to study protocols, maintain accurate and complete documentation, recruit and screen potential study participants, and ensure that all regulatory and protocol requirements are met in accordance with ICH/GCP, federal regulations, and institutional and sponsor guidelines., • Identify instances of protocol noncompliance and deviations, document them appropriately, and report them promptly to the required parties., • 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 in alignment with protocol requirements., • Support Principal Investigator oversight by providing timely updates on protocol issues and obtaining signatures and clinical significance assessments on laboratory reports, ECGs, adverse events, and other required documents., • Develop and participate in the delivery of training for new protocols, including creating training materials, protocol-specific tool kits, and nursing in-service presentations, and determining appropriate training methods, timing, and frequency., • Provide direct patient care and research-related clinical assessments, including performing electrocardiograms and administering research instruments according to study protocol requirements., • Maintain the integrity of clinical research studies by advocating for patients and families and serving as a clinical resource for triaging and addressing research-related inquiries generated from institutional websites and professional presentations., • Educate study participants and families on study procedures, medications, dosing, administration, and potential side effects to promote understanding and safe participation in clinical trials., • Serve as the front-line medical resource for interpreting protocols to medical and nursing staff, particularly regarding medication dosing, treatment plans, and safety considerations related to study drugs or interventions., • Participate in monitoring visits and external audits, including sponsor and regulatory agency (e.g., FDA) reviews, to support smooth, compliant, and successful outcomes., • Track, document, and report adverse events, serious adverse events, protocol waivers, deviations, and violations in accordance with regulatory and institutional requirements., • Consent patients for participation in clinical trials, ensuring that informed consent is obtained appropriately and documented accurately., • Build and coordinate treatment plans in collaboration with pharmacy and the research team to align with protocol-specific requirements and patient safety standards., • Manage multiple concurrent clinical trials (often up to approximately 15 studies at once), prioritizing tasks and resources to meet protocol timelines and patient needs., • Coordinate patient care across the continuum of study participation, including scheduling, follow-up visits, assessments, and communication among multidisciplinary team members., • Perform meticulous documentation, data entry, and record maintenance to ensure data integrity and support accurate reporting., • Collaborate closely with investigators, clinical research coordinators, pharmacists, and other multidisciplinary team members to ensure cohesive trial operations., • Maintain patient confidentiality and protect sensitive information in all aspects of clinical research work., • 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 research protocols., • Demonstrated experience and comfort managing multiple clinical trials simultaneously, ideally 10 or more at once., • Strong oncology research experience, with the ability to work effectively within complex cancer clinical trials., • Proven ability to interpret complex clinical trial protocols and assess subject suitability for inclusion., • Proven ability to obtain informed consent, determine patient eligibility, and coordinate patient enrollment in clinical studies., • Excellent clinical, analytical, and organizational skills with demonstrated research nursing capability., • 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 applications such as Word, Excel, and PowerPoint., • Knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations., • Knowledge and use of Clinical Trials Management Systems (CTMS)., • Proven ability to multi-task and remain focused in a fast-paced environment while managing multiple competing priorities., • Proven ability to maintain confidentiality and handle sensitive patient and research information appropriately., • Excellent time management and organizational skills, with the ability to meet deadlines and protocol timelines., • Strong interpersonal and communication skills, with the ability to communicate effectively with patients, families, and multidisciplinary team members., • Experience in oncology within a research setting is preferred, particularly in hematology and liquid tumors such as leukemia., • Experience working with Institutional Review Boards (IRBs) and federal regulations related to clinical research is preferred., • ACRP, SOCRA, or equivalent clinical research certification is preferred., • Oncology Nursing Society (ONS) certification is preferred., • Experience with hematology-focused oncology trials is a strong plus., • Experience consenting patients for clinical trials and documenting adverse events and serious adverse events., • Experience collaborating with pharmacy to build and manage protocol-specific treatment plans., • Familiarity with clinical research roles and environments such as CRA, CTMS usage, and oncology-focused professional organizations., • Demonstrated ability to thrive in an academic medical and cancer research environment with structured protocols and regulatory oversight. This position is based in an academic medical center and cancer research setting that focuses on oncology clinical trials. The role operates within collaborative, multidisciplinary clinical research teams that include physicians, nurses, coordinators, pharmacists, and other specialists. The environment is patient-focused, with structured protocols, rigorous regulatory oversight, and a strong emphasis on quality and compliance. The work week is typically 40 hours, and candidates are expected to be flexible with start and end times based on workload and study demands. The culture is mission-driven, research-oriented, and dedicated to advancing cancer treatment through innovative clinical trials, offering exposure to complex protocols, professional development opportunities, and meaningful patient impact. Job Type & Location This is a Permanent position based out of New Haven, CT. Pay and Benefits The pay range for this position is $105000.00 - $115000.00/yr. 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 • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. 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