APPLICANTS MUST RESIDE IN HAWAII
Duties & Responsibilities:
- Independently organizes and manages activities and tasks associated with the conduct of early-phase industry-sponsored and investigator-initiated cancer clinical trials in the Ho‘ōla Early-Phase Clinical Research Center (EPCRC).
- Works with the clinical trial operation team to identify and inform candidate patients about available clinical protocols, enrolls consenting eligible patients and follows enrolled patients.
- Collects, documents, and enters data accurately and timely into case report forms, electronic medical record, and electronic data capture systems as required per protocol.
- Works with the clinical operation staff to ensure standard of care procedures are identified. Responsible for multiple functions needed to access, select and activate protocols and to maintain a high level of training, continuing education, quality control, and regulatory compliance for the enterprise.
- Works closely with the PI and his/her designee, with nurses and other staff in EPCRC, and with physicians/investigators to foster strong working relationships to ensure compliance with the conduct of industry and investigator-initiated research.
- Follows the standards and practices of the International Conference on Harmonization for Good Clinical Practices.
- Handles confidential information responsibly. Maintains confidentiality of patient information in accordance with Health Insurance Portability and Accountability Act (HIPAA).
- Maintains training as required in human subjects’ research and all other requirements of UHP.
- Complies with all legal requirements and company policies.
- Performs all other duties as assigned.
Please see the attached job description for more information.
QUALIFICATION REQUIREMENTS
Education/Training/Experience
Minimum:
- Bachelor’s Degree from an accredited four (4) year college or university in a health-related field, or an equivalent number of years of relevant healthcare experience. Relevant education, training, and professional experience in a health-related field may be considered in place of a degree.
- Three (3) years of experience working in health research/clinical trials including at least one year of oncology OR 5 years working in a health care clinic setting.
Preferred:
- Advanced Degree from an accredited college or university in a related field.
- Previous experience of early-phase industry-sponsored and investigator-initiated cancer clinical trials is preferred.
Skills Knowledge
Minimum:
- Works autonomously with minimal supervision, while also understanding the boundaries of the role, responsibilities, and experience. Seeks guidance and clarification from appropriate protocol-involved personnel when necessary.
- 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) requirements .
- Understanding of research study designs and ethics.
- Knowledge of and experience with computers and software programs, including word-processing, spreadsheets, and databases.
- 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 regulatory compliance auditing.
- Demonstrates strong organizational skills, attention to detail, accuracy, desire to learn, and timeliness of work.
- Strong and effective written and verbal communication skills, and interacts with supervisors, co-workers, and others respectfully and professionally at all times.
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
UHP Hawai‘i is an EEO/AAP employer.
