What are the responsibilities and job description for the CLINICAL RESEARCH NURSE - ONCOLOGY position at Toledo Clinic?
General Summary:
The Clinical Research Nurse will ensure the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and with program Standard Operating Procedures. This position is also responsible to ensure completeness, accuracy and compliance with each protocol and to assist Investigators of clinical studies in coordinating and facilitating the activities of study patients.
Principal Duties & Responsibilities:
- Clinical: Providing nursing care to research study participants.
- Ensures compliance with each study’s protocol by providing thorough review and documentation at each subject study visit.
- Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements. Interfaces with study participants, to support efforts to determine eligibility and consenting requirements according to protocol.
- Performs medical or research required tests, including, but not limited to, vital signs, imaging studies, specimen collection and processing, and electrocardiograms.
- Administers investigational medications, as applicable, and performs patient assessments during clinic visits to determine presence of side effects; notifies Principal Investigator of findings/issues.
- Provides patient education and medical information to study participants to ensure understanding of proper medication dosage, administration, and disease treatment.
- Documents medical data in patient chart to capture protocol requirement.
- Administrative and Research: Ensuring assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and Good Clinical Practices (GCP) guidelines.
- Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.
- Develops accurate source materials and ensures compliance.
- Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and TCCC electronic medical record, databases / Clinical Trial Management System (CTMS), etc.
- Supports clinical research operations team in the maintenance of regulatory documents in accordance with SOP and applicable regulations.
- Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, Investigators, and study patients.
- Participates with the research operations team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance.
- Maintains good rapport and cooperative relationships. Approaches conflict in a constructive manner. Helps to identify problems, offer solutions, and participate in their resolution.
- Maintains the confidentiality of information acquired pertaining to patient, physicians, employees, and visitors. Discusses patient and hospital information only among appropriate personnel.
- Assumes responsibility for performance of job duties in the safest possible manner, to assure personal safety and that of coworkers, and to report all preventable hazards and unsafe practices immediately to management.
- Actively demonstrates the organization's mission and core values and conducts oneself at all times in a manner consistent with these values.
- Knows and adheres to all laws and regulations pertaining to patient health, safety and medical information.
Knowledge, Skills & Abilities:
Required:
- Minimum 8 years of nursing experience in medical practice.
- Strong team-oriented, results driven and collaborative style. Proven success in identifying partners and negotiating and executing complex deals.
- DOT/IATA Training (must be obtained within 30 days of hire)
- Certification in Human Subjects Protection, Good Clinical Practices (must be obtained within 30 days of hire)
- Adheres to all Toledo Clinic policies and procedures.
Education:
- Registered Nurse with current license to practice in the State of Ohio.
Preferred:
- Relevant Nursing and Clinical Research experience in Oncology, Phase 1 translational research and biospecimen procurement and handling.
- Certification as a Clinical Research Associate or Coordinator
- Proven knowledge in clinical research practices, patient treatment and coordination and clinical data management with a minimum 8 years in Investigator Initiated and Industry Sponsored, FDA regulated, clinical trials.
- Knowledge of GCP.
