Registered Nurse RN Clinical Research Specialist Outpatient Infusion

Clinical Research Nurse

This position provides direct patient care and therapeutic administration of early and late phase investigational products according to research protocols. This position also assesses, plans, implements, evaluates and documents nursing care of patients in accordance with organizational policies and in accordance with standards of professional nursing practice utilizing the framework for professional nursing practice and development. This position is accountable for the quality of nursing services delivered by self or others who are under their direction. This position utilizes specialized knowledge, judgment, and nursing skills necessary to assess data and plan, provide and evaluate care appropriate to the physical and developmental age of assigned patients. Will also have administrative responsibilities within the Clinical Trials Office, which include but are not limited to reviewing research protocols, attending departmental, committee, study coordination and Sponsor meetings for the purpose of gathering new or revised information concerning existing or potential clinical research protocols.

Core Functions:

• Cares for and monitors patients enrolled on both early and late phase clinical trials. Administers investigational products and standard chemotherapy, immunotherapy, biologic agents, and supportive care medication according to protocol, institutional policy, and safety guidelines. Manages patients based upon acuity utilizing the research acuity scale. Supports additional clinical research functions which include but are not limited to, attending Site Initiation Visits (SIV), collaborating with clinical research coordination team on clinical nursing reference sheets, clinical research support, and protocol implementation planning (PIP) meeting when there is no conflict with daily research infusions.
• Performs protocol-specific assessments and monitor for adverse events, infusion reactions, and clinical changes. Reports findings per protocol and regulatory requirements. Collaborates closely with Principal Investigators, Clinical Research Coordinators, pharmacists, and other healthcare providers to ensure accurate implementation of clinical trial protocols. Maintains thorough and accurate documentation of treatments, assessments, and protocol specific activities in the electronic medical record (EMR) and research source documents. Participates in study startup activities such as infusion feasibility review, protocol education, and development of treatment orders and workflows. Collaborates with Clinical Research Coordination team on developing clinical nursing reference sheets/clinical research support to be used in tandem with the EMR for clinical documentation, protocol monitoring, and data collection.
• Manages infusion-related logistic including scheduling, pre-medication administration, lab draws, IV access, and post-infusion monitoring. Maintains working knowledge of Good Clinical Practice (GCP), FDA regulations, and institutional SOPs related to clinical trials. Educates patients and caregivers about clinical trials, treatment plans, potential side effects, and symptom management. Assists in protocol audits and data queries as needed.
• Assesses patient physical, psychological, social, spiritual, educational, developmental, cultural and discharge planning needs. Reviews patient history and physical with patient/family and assures completion within appropriate timeframe. Reviews available information obtained by other health care team members. Reviews diagnostics and laboratory data and reports abnormal results to the physician(s) and other appropriate caregivers. Completes assessment and reassessments according to patient need and as outlined in policy.
• Formulates a plan of care, including the timeliness of blood pharmacokinetics time points, monitoring parameters indicated per schedule of events and accuracy of the delivery of investigational products needed per clinical research protocol. Initiates a plan of care based on patient-specific needs, assessment data and the medical/research plan of care. Ensures goals for patient are realistic, measurable and developed in conjunction with the patient/family. Considers the physical, cultural, psychosocial, spiritual, age specific and educational needs of the patient in the plan of are. Plans care in collaboration with members of the multidisciplinary team.
• Implements the plan of care through direct patient care, coordination, delegation and supervision of the activities of the health care team. Provides care based on physician orders and the nursing plan of care, in compliance with policies and procedures, standards of care, and regulatory agency requirements. Delegates appropriately and provides nursing supervision in the provision of care to patients by other licensed nurses and other personnel. Promotes continuity of care by accurately and completely communicating to other caregivers the status of patients for whom care is provided. Evaluates the patient's and family's response to care and effectiveness of teaching. Revises the plan of care to reflect changing patient needs based on evaluation of the patient's status as needed. Evaluates patient progress towards goals and expected outcomes in collaboration with other health care team members.
• Documents assessment, planning, implementation and evaluation in the patient record. Documentation on additional source documents will be required per clinical research protocols for extra level of monitoring for early phase clinical trials. Confirms documentation is legible, timely and in accordance with policy. Ensures documentation reflects objective/subjective data, nursing interventions and patient's response to treatment. Notes physician orders accurately and in a timely manner.
• Provides care based on the best evidence available and may participate in research activities within clinical practice. Participates in unit or facility shared leadership. Interacts and participates in the education, role development, and orientation of facility personnel, patients, students, families and visitors. Promotes/supports growth of others through precepting and mentoring when appropriate. Contributes to society through activities that lead to excellent patient outcomes through timely, effective, efficient, equitable, and safe care. Actively participates in the improvement of national nursing quality indicators and outcomes. Such activities may include participating in professional organizations.
• Interacts with all levels of staff in a variety of departments, including physicians, clinical research coordinators, patients, families, and external Sponsor contacts, such as employees of other health care institutions, and agencies concerning the health care of the patient. Interacts with other health care providers in numerous settings to report and ask for or clarify information. Works with clergy to provide spiritual support. Synthesizes and prioritizes data from multiple sources to provide support for the human response of the patient and family to changes in health status.

Minimum Qualifications:

• Must possess a current, valid RN license in state of practice, temporary/interim RN license in state of practice, or compact RN licensure for current state of practice. BLS certification is required. Additional certification or continuing education may be required based on area of practice.
• Must have 2-3 years of nursing or research experience in oncology, cardiology, neurology and in the acute care setting.
• Knowledge of medical and clinical terminology. Excellent organizational and task management skills and the ability to maintain confidentiality of patient and study information. Ability to maintain knowledge of Federal and State regulations governing practice as well as Institute policies and procedures related to medical and nursing practice. Excellent human relations, organizational and communication skills.

Preferred Qualifications:

• Bachelor's degree preferred.
• Oncology Certified Nurse (OCN) Certification preferred.
• Chemotherapy/Biotherapy Certification.
• Previous relevant experience working in a clinical research setting. Regulatory knowledge regarding the conduct of clinical research or health care operations is preferred.
• Additional research related education and/or experience preferred.

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