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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'?la 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.
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.
Clinical Research Coordinator • Honolulu, HI, United States
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