Early Phase Clinical Research Nurse

Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

The Early Phase Clinical Research Nurse plays a critical role in the safe, compliant, and efficient conduct of early phase clinical trials at the Tennessee Oncology Greco Hainsworth Center for Research. This position provides comprehensive, patient-centered clinical care to research participants throughout the screening, treatment, and follow-up phases of clinical trials while working closely with the Principal Investigator (PI), delegated investigators, research team, and multidisciplinary clinical staff.

The Early Phase Clinical Research Nurse is responsible for coordinating and performing protocol-required clinical assessments and procedures, monitoring participants for treatment-related toxicities and adverse events, supporting investigational product administration, coordinating pharmacokinetic and other research specimen collections, providing participant education, and ensuring accurate and timely clinical and research documentation.

The position requires a high level of clinical judgment, organization, attention to detail, and knowledge of Good Clinical Practice (GCP), regulatory requirements, and early phase research processes. The nurse must be able to recognize changes in participant condition, promptly communicate safety concerns, and ensure protocol-required assessments and interventions are completed within specified time points and visit windows.

ESSENTIAL FUNCTIONS:

·         Coordinate and provide comprehensive nursing care to participants enrolled in early phase oncology clinical trials from screening through treatment and long-term follow-up.

·         Review study protocols, treatment plans, eligibility criteria, schedules of assessments, and safety requirements to ensure accurate execution of protocol-specific activities.

·         Collaborate with the PI and delegated investigators to evaluate participant eligibility, clinical status, treatment readiness, and ongoing participation in clinical trials.

·         Serves as the primary contact for assigned early phase research participants from informed consent through study completion.

·         Screen and assess potential research participants in collaboration with the investigator and research team to determine eligibility according to protocol-specific inclusion and exclusion criteria.

·         Facilitate the informed consent process and enroll eligible participants in accordance with protocol, regulatory, and institutional requirements.

·         Provide comprehensive participant education regarding study requirements, treatment expectations, investigational products, potential risks and benefits, medication administration, required procedures, and when to contact the research team.

·         Perform comprehensive and focused nursing assessments as appropriate to the study and participant's clinical condition.

·         Obtain and document protocol-required vital signs, weight, height, oxygen saturation, pain assessments, performance status, and other clinical assessments.

·         Monitor participants closely before, during, and after investigational treatment for adverse events, treatment-related toxicities, infusion or hypersensitivity reactions, and other changes in clinical condition.

·         Recognize and promptly communicate clinically significant findings to the PI, delegated investigator, and appropriate members of the research team.

·         Identify, assess, document, and follow up on adverse events (AEs), serious adverse events (SAEs), and other safety-related findings in accordance with protocol and regulatory requirements.

·         Ensure timely PI or delegated investigator review and assessment of clinically significant findings and safety events.

·         Review scheduled and unscheduled participant encounters, including emergency department visits, hospitalizations, and outside medical records, to identify potential AEs, concomitant medications (ConMeds), and other clinically relevant information requiring follow-up.

·         Coordinate and perform protocol-required clinical procedures within scope of practice, including venipuncture, ECGs, specimen collection, port access, infusion-related activities, and other study-specific procedures.

·         Administer investigational products and supportive medications as permitted by licensure, protocol requirements, institutional policy, and delegation of authority.

·         Access implanted vascular access devices (ports) and establish peripheral intravenous (IV) access as appropriate.

• Collect protocol-required laboratory specimens and ensure proper specimen handling, processing, and shipment according to protocol requirements.
• Conduct and coordinate pharmacokinetic (PK), pharmacodynamic (PD), and other protocol-required research assessments, including collection of biological specimens at precise protocol-defined time points.

·         Perform and accurately document protocol-required calculations, including body surface area (BSA), creatinine clearance, dose calculations, dose modifications, urine protein-to-creatinine ratios, and other study-specific calculations.

• Monitor patients for infusion reactions, adverse events, dose-limiting toxicities, and other treatment-related complications.
• Review and reconcile participant medications and maintain accurate documentation of ConMeds and medication changes throughout study participation.

·         Educate participants regarding investigational and supportive medications, including dosage, administration, storage, adherence, potential side effects, and required reporting of missed doses or adverse symptoms.

·         Monitor investigational product compliance and accountability and collaboration with pharmacy and research staff as applicable.

·         Coordinate protocol-required laboratory testing, imaging, procedures, appointments, and follow-up visits to ensure completion within required study windows.

·         Maintain accurate, complete, contemporaneous, and attributable source documentation for all participant encounters, assessments, procedures, treatments, and clinical findings.

·         Ensure timely and accurate entry of clinical and research data into the EMR, electronic data capture systems, and other applicable research databases.

·         Apply Good Clinical Practice (GCP), ALCOA/ALCOA+ principles, HIPAA, Human Subjects Protection requirements, and applicable regulatory standards to all research activities and documentation.

·         Identify and appropriately escalate protocol deviations, safety concerns, missed assessments, out-of-window procedures, and unresolved clinical or research-related issues.

·         Collaborate with clinical research coordinators, physicians, APPs, pharmacists, laboratory personnel, pathologists, sponsors, clinical research associates, and other members of the multidisciplinary research team.

·         Serve as a primary clinical resource for research participants and assist in coordinating communication between participants, investigators, and the research team.

·         Participate in sponsor monitoring visits, audits, inspections, quality assurance activities, and other study-related activities as required.

·         Assist with study start-up activities, including review of protocols, study-specific training, development of clinical workflows, and preparation of clinical areas and research materials.

·         Maintain current knowledge of assigned protocols and promptly communicate protocol amendments, safety updates, and changes in study requirements to appropriate team members.

·         Maintain required certifications and training in GCP, Human Subjects Protection, chemotherapy/biotherapy, biological specimen handling and shipping, and other study-specific requirements.

·         Complete all required study-specific training, continuing education, and competency validations within established timelines.

·         Participate in research meetings, staff meetings, committees, quality improvement initiatives, and educational programs as requested.

·         Support clinical research activities at other Tennessee Oncology research locations as needed.

·         Maintain participant confidentiality and comply with HIPAA, institutional policies, Tennessee Oncology standards, and applicable federal, state, and regulatory requirements.

·         Consistently demonstrate and role-model the Tennessee Oncology Code of Conduct, mission, values, professionalism, and commitment to patient-centered research.

·         Perform other duties and responsibilities as assigned in support of the clinical research program.

KNOWLEDGE, SKILLS & ABILITIES:

·         Knowledge of medical and research terminology

·         Knowledge of FDA Code of Federal Regulations and GCP

·         Knowledge of clinical research processes preferred.

·         Knowledge of investigational therapies, infusion monitoring, adverse event assessment, vascular access, protocol-specific procedures, and time-sensitive research assessments preferred.

EDUCATION & EXPERIENCE:

• Active RN License in Tennessee and/or Georgia 
• Bachelor of Science in Nursing (BSN) preferred or equivalent. Associate Degree in Nursing (ADN) from an accredited nursing program will be considered based on relevant clinical and research experience.
• 5 years clinical nursing and at least 1 year research/oncology nursing required.
• ONS Chemotherapy – Immunotherapy certification required at the time of or within 3 months of hire.
• AHA or ARC BLS certification required at the time of hire or within 3 months of hire.
• ACRP/CCRP certification preferred.
• OCN preferred