ESSENTIAL JOB DUTIES AND FUNCTIONSKey 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 REQUIREMENTSEducation/Training/ExperienceMinimum:
- 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 KnowledgeMinimum:
- 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
