Bachelor's Degree in Nursing or an Associate's Degree with 2+ years in health sector
State of Hawai'i RN license required
CITI Human Subject training within three months of hire
Current BLS and ACLS CPR Certification
4 years of RN experience in oncology or clinical trials
Responsibilities
Provide education and support to oncology clinical trial patients
Ensure compliance with clinical trial protocols and regulatory standards
Identify potential study candidates through medical record and clinic schedule screening
Coordinate and conduct all required study visits and patient assessments
Manage study calendars with the Clinical Trial Management System team
Document and report protocol deviations and adverse events
Monitor patient safety and collaborate with physicians
Maintain investigational drug accountability records and educate patients on drug administration
Benefits
Generous time off benefits
100% employee health and dental coverage
Flexible spending plan
Retirement plan with dollar-for-dollar company matching
Company paid Life/AD&D/LTD insurance
Employee assistance program (EAP)
Pet insurance and prepaid legal assistance
Full Job Description
ESSENTIAL JOB DUTIES AND FUNCTIONS
Key Responsibilities
Independently provides education, support, and clinical care to patients participating in oncology clinical trials. Coordinates and follows patients throughout all phases of study participation, including screening, enrollment, consenting, treatment, and follow-up.
Ensures the effective and ethical conduct of clinical trials in compliance with protocol requirements, regulatory standards, and institutional policies.
Screens medical records and clinic schedules to identify potential study candidates and matches patient characteristics with protocol eligibility criteria.
Coordinates and conducts protocol-required study visits, including patient assessments, ordering and coordinating tests and procedures, collecting specimens, administering or dispensing investigational agents (as directed by the physician), and monitoring patient responses to study interventions.
Develops and manages study calendars in collaboration with the Clinical Trial Management System team and ensures timely completion of all study-related activities.
Ensures strict adherence to study protocols and documents and reports deviations, violations, and serious adverse events according to regulatory and sponsor requirements.
Monitors patient safety by assessing for adverse events, changes in condition, concomitant medication use, and protocol compliance, and collaborates closely with physicians to manage and document findings.
Maintains accurate and complete investigational drug accountability records and provides patient education related to study drug administration when applicable.
Collects, processes, prepares, and ships patient specimens in accordance with protocol requirements.
Assists in collecting and transmitting patient-reported outcomes and questionnaires as required by study protocols.
Please see the attached job description and the Ho'ōla Early Phase Clinical Research Center webpage for more information.
QUALIFICATION REQUIREMENTS
Education/Training/Experience
Minimum:
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 and ACLS 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 infusions.
Four years of experience as a Registered Nurse (RN) in a related clinical specialty (e.g., oncology) or clinical trials experience in oncology.
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
