Job Description

ESSENTIAL JOB DUTIES AND FUNCTIONS

• Independently oversees education, support and conducts research using sound nursing judgement, critical thinking, and clinical knowledge and skills. Responsible for the effective and ethical conduct of oncology clinical trials. Coordinates, evaluates, and follows patients in clinical trials, which includes but is not limited to screening, identifying, enrolling and consenting patients, developing study calendars with Clinical Trial Management System team, coordinating study visits and follow-ups, and any other study-related activities. Ensures adherence to protocol requirements, and reports and documents deviations as appropriate. Performs protocol-specific clinical tasks including patient assessment, ordering tests, collecting specimens, and monitoring responses to interventions. Serves as a resource to research and clinical staff regarding protocol requirements. Reviews clinic schedules and medical records of potential clinical trials participants, matching patient characteristics with eligibility requirements of available protocols. Assists physicians and cancer care staff in coordinating laboratory tests/procedures required for pre-study testing. May dispense investigational drug under the direction of the physician, and provide patient teaching regarding administration. Maintains accurate investigational drug accountability records. Assists in collecting, processing, and preparing patient specimens for shipment as required by protocol. Assists in collecting and transmitting patient-reported information (questionnaires).
• Provides general clinical research, as well as study-specific information to patients and research, clinical, and other organizational staff. Serves as a resource to CRAs for any study-related issues to facilitate coordination amongst various hospital/clinic departments as required by the studies.
• Ensures validity of research results by ensuring timely, accurate and complete data documentation, reporting deviations, violations and serious adverse events. Responsible for all protocol data collection including completion of initial study forms, treatment forms and follow-up forms. Enters all patient tracking information into OnCore Clinical Trials Management System and/or other required data capture system in a timely manner. Reviews data for accuracy and submits data within time requirements, electronically if required.
• Ensures patient safety. Monitors patients for adverse events and reports according to standard guidelines or as specified in the protocol. In collaboration with the physician, reviews patients for changes in conditions, adverse events, concomitant medications use, protocol compliance, response to study drug, and thoroughly documents all findings. Monitors patients for serious adverse events per Federal and/or sponsor guidelines, within the time parameters.
• Develops relationships with community partners to facilitate accrual to and compliance with clinical trials. Assists in implementation of recruitment plans to identify and assess potential clinical trial participants. Identifies and develops processes to overcome barriers to clinical trial enrollment.
• Assists in the maintenance and distribution of clinical protocols available for patient enrollment. Provides input on new studies and study continuation. Assists in reviewing availability for industry-sponsored trials and communicating opportunities with clinical research staff and affiliated oncology practitioners.
• Attends UHCC clinical meetings and tumor boards at local hospitals. Completes feasibility forms and PowerPoint slides for UHCC meetings as needed. Assists in preparing for external audits and in developing corrective action plans as needed. Participates in quality assurance internal audits. Works with regulatory staff to develop patient consents.
• Provides in-service training on protocol requirements to clinic staff by working closely with the PI and staff to ensure that clinical procedures are completed according to protocol. This includes preparing amendments and any changes or updates in procedures and activities, which support the protocol, and disseminating all pertinent information affecting study conduct to staff throughout the duration of the study. Prepares and organizes materials for distribution to patients and clinics.
• Provides mentoring, education, and problem solving to research team. Advocates for clinical trials by participating in community outreach efforts to provide general clinical trials education when opportunities arise. Oversees students and/or volunteers. May mentor and train CRAs and other research support staff.
• Acts as the team's lead authority for specific technical areas of clinical trials, such as training, continuing education, and quality control. Maintains working knowledge of oncology clinical care and research. Participates in education, instruction, and professional development as necessary to maintain job-related skills and competencies. Completes continuing medical education courses as deemed relevant and attends meetings and conferences as appropriate.
• Provides in-service training on protocol requirements to clinic staff by working closely with the PI and staff to ensure that clinical procedures are completed according to protocol.
• Complies with all legal requirements and company policies.
• Maintains patient confidentiality at all times.
• Performs all other duties as assigned.

• Bachelor's Degree from an accredited four (4) year college or university in Nursing. (Associate's Degree from an accredited community college in Nursing with at least two (2) years of professional experience in health sector may substitute for a Bachelor's Degree.)
• Must possess a State of Hawai'i RN license
• Must complete Collaborative Institutional Training Initiative (CITI) Human Subject training within three (3) months from date of hire.
• Current BLS CPR Certification
• Four years of experience as a Registered Nurse (RN) in a related clinical specialty (e.g., oncology) or clinical trials experience in oncology.

Preferred:

• Master's Degree from an accredited college or university in Nursing.
• Oncology Certified Nurse (OCN), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP).
• Experience in IV access placement, venous access devices, oncology medication administration and monitoring including oral therapies, injections and infusion

Skills/Knowledge
Minimum:

• Demonstrated knowledge in human subjects' research and International Conference on Harmonization (ICH)
• Demonstrated knowledge in Good Clinical Practices (GCP)
• Demonstrated knowledge in Health Insurance Portability and Accountability Act (HIPAA) training.
• Understanding of research study designs and ethics.
• Knowledge of and experience with computers and software programs, including word-processing, spreadsheets, and database.
• Specialized knowledge of clinical trial protocols grouped from a specific National Cancer Institute (NCI) research base, other source, or by disease site, etc.
• Specialized knowledge of specific cancer care sites conducting clinical trials or of job areas, such as education/training, regulatory, investigational drug accountability/storage, specimen collection/processing, database maintenance/reporting, and auditing.
• Strong and effective written and verbal communication skills.

Preferred:

• Working knowledge of the University of Hawai'i and UHCC policies and procedures.

BENEFITS

• Generous time off benefits
• 100% employee health and dental coverage and vision
• Flexible spending plan
• Retirement plan with up to 3% dollar-for-dollar company matching contributions
• 100% company paid group Life/AD&D/LTD insurance
• Employee assistance program (EAP)
• Pet Insurance, Prepaid legal with competitive rates

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