Coordinator, Regulatory Documents - Clinical Trials Job at Hawaii Pacific Health
Hawai'i Pacific Health is a not-for-profit health care network with over 70 locations statewide including medical centers, clinics, physicians and other caregivers serving Hawai'i and the Pacific Region with high quality, compassionate care. Its four medical centers - Kapi'olani, Pali Momi, Straub and Wilcox - specialize in innovative programs in women’s health, pediatric care, cardiovascular services, cancer care, bone and joint services and more. Hawai'i Pacific Health is recognized nationally for its excellence in patient care and the use of electronic health records to improve quality and patient safety.
Through clinical trials, the newest, most promising medications, medical devices, and treatment protocols are made available to patients. The Clinical Trials team at Hawai‘i Pacific Health Research Institute (HPHRI) supports clinical trials within the Hawai‘i Pacific Health network of hospitals to expand our knowledge and better provide top quality medical care to Hawai‘i’s populations. We participate in more than 200 clinical trials a year, working with more than 70 principal investigators who are overseen by our highly trained professional staff of care providers and research managers.
As the Research Regulatory Document Coordinator, you will help the Hawai‘i Pacific Health Research Institute meet its goals of expanding knowledge and best practices related to health care in Hawai‘i. Your responsibilities include general protocol implementation, including budget development, regulatory document completion, investigator and site certification; and assisting the research staff with other regulatory document requirements as needed. We are looking for someone with an exceptional sense of research protocol and operational integrity and a commitment to delivering the highest quality health care to Hawai‘i’s people.
*Under the Centers for Medicare and Medicaid Services (CMS) Federal Vaccination Mandate, all health care workers must be fully vaccinated against COVID-19 or have an approved medical or religious exemption from receiving the COVID-19 vaccination.*
Location: Hawaii Pacific Health, Honolulu, HI
Work Schedule: Day - 8 Hours
Work Type: Full Time Regular
FTE: 1.000000
Bargaining Unit: Non-Bargaining
Exempt: No
Minimum Qualifications: Bachelor’s degree and/or equivalent combination of education, training and experience. Access database and Microsoft Office skills. Valid driver's license and abstract. Current Hawai‘i auto insurance.
Preferred Qualifications: Research experience. Knowledge of Food and Drug Administration and Good Clinical Practices guidelines.
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