Research Nurse

• Coordinates the day-to-day management of clinical trial, ensuring that the study is conducted in accordance with relevant legislation, research protocols and guidelines

• Screens patients to determine if appropriate for enrollment in clinical trial, maintain screening logs, complete inclusion-exclusion eligibility, obtain and document participant consent

• Provides education and information to study participants and families about clinical research participation and compliance. Discusses study issues with the study investigators, serving as a liaison/advocate between the participant/family and the physician

• Coordinates patient study enrollment, collect source documentation from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Enters data into relevant EDC in a timely manner

• Identifies actual or potential patient/family problems and involves all needed disciplines in the planning and implementation of actions to address these concerns

• Administers care to patients, as needed, to maintain clinical and research skills, to assess patient care requirements or to provide support to patient care staff

• Collects and submits data to sponsors and database as required; ensures that clinical research data is accurate, legible, timely and in compliance with the requirements of the study

• Reconciles data queries in a timely manner by communicating with sponsors and submitting the requested information

• Communicates the protocol schedule for each patient, including but not limited to the following: tests, procedures, diagnostics, and consultations to both the patient and the relevant clinical team. Adheres to and complies with protocol specific requirements

• Assists PI with the identification and reporting of deviations, serious adverse event, or unanticipated problems

• Collaborates and identifies Serious Adverse Events (SAE), Adverse Events (AE), and Unanticipated Problems (UP) and facilitates the grading and attribution with the Study Investigator and reports both internally and externally according to study specific guidelines

• Identifies potential or actual deviations from study requirements and standards of practice

• Attends and participates in protocol site initiation visits and any other applicable sponsor meetings or calls

• Meets with medical investigators on a regular basis to review clinic for potential patients, maintain MD screening and new visit logs

• Utilizes organization’s electronic health record and departmental calendars to screen patients and coordinate necessary assessments. Develop and maintain patient study tracker to ensure patient protocol compliance

• Ensures that the required information is complete, accurate, and readily available for clinical research audits or study sponsor monitor visits,
  i.e.: medical records, case report forms and other source documents.
• Must be available during monitor site visits or audits to answer questions and resolve identified issues and concerns

• Participates in EPIC beacon build configuration for oncology treatment plans

• Provides research study education to ambulatory and inpatient nursing, and others involved in the care of the research patient

• Coordinates the collection and handling of specimens required by clinical research studies and collaborates with the Laboratory Team to ensure the specimens are processed in accordance with study requirements

• Participates in the orientation of new personnel ensuring an environment which promotes learning and mentoring by experienced staff members

• Provides cross coverage to other clinical research nurse and/or coordinators as needed

• Develops interdepartmental relationships with internal and external stakeholders including pharmacy, laboratory, pathology, trial sponsor, sponsor medical science liaisons, regulatory agencies, CRO, outside data collection agencies and others

• Maintains established departmental policies and procedures, objectives, quality assurance programs, safety and compliance standards

• Enhances professional growth and development by participating in educational programs, reading current literature, and participating in in-service meetings and workshops

• Participates and pre-screen patients for multi-disciplinary tumor boards. Collect data to present on Cancer Committee Meetings

• Communicates on a regular basis with Research Oncology Manager

• Practices regular hand hygiene and complies with standard and transmission based precautions as applicable

• Responds appropriately to the special needs of each group served specific to age, language, gender, culture, religion/spirituality, economic background, education or literacy, developmental or cognitive disabilities, physical and developmental disabilities

NOTE: The duties described in this job classification standard are intended only as illustrations of the various types of work that may be performed by employees in this title. The omission of specific duty descriptions does not exclude them from the job if the work is similar, related or a logical assignment for the title. This job classification standard does not constitute an employment agreement between the individuals employed in this title and Good Samaritan University Hospital and is subject to change by the employer as the needs of the employer and requirements of the job change.