Coordinator, Regulatory Documents - Clinical Trials

Hawaii Pacific Health; Honolulu (HI); On-site; USD 45,000 - 57,000; Full time

Job summary

Hawai‘i Pacific Health Research Institute (HPHRI) seeks a Research Regulatory Document Coordinator to support protocol implementation, including budget development, regulatory document completion, investigator and site certification. The role involves assisting the research staff with regulatory document requirements to ensure compliance within Hawai‘i’s health network.

Location: Harbor Court, Honolulu. Work Schedule: Day 8 Hours.

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: Research experience; Knowledge of FDA and GCP guidelines.

Responsibilities

• As Research Regulatory Document Coordinator, support protocol implementation, budget development, regulatory document completion, and investigator/site certification.
• Assist the research staff with other regulatory document requirements as needed.

Education

Bachelor’s degree

Equivalent combination of education, training and experience

Tools

Access Database

Microsoft Office

Job description

The Hawai‘i Pacific Health Research Institute (HPHRI) is dedicated to expanding our knowledge and investigation of the most advanced methods of health prevention in Hawai‘i. HPHRI researchers conduct more than 200 clinical trials within the Hawai‘i Pacific Health network of hospitals — Kapi'olani Medical Center for Women & Children, Pali Momi Medical Center, Straub Clinic & Hospital and Wilcox Memorial Hospital. The Institute oversees an impressive array of research projects, covering areas such as oncology, cardiology, emergency medicine and neonatology. It manages a multi-million dollar budget and a dedicated staff that includes more than 25 clinical research coordinators and up to 75 physicians. Our studies assure patient safety in all aspects of research as they break new ground in the prevention, diagnosis and treatment of diseases.

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.

Location: Harbor Court

Work Schedule: Day - 8 Hours

Work Type: Full Time Regular

FTE: 1.000000

Bargaining Unit: Non-Bargaining

Exempt: No

Req ID 34617

Pay Range: 33.02 - 41.27 USD per hour

Category: Research

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.

EOE/AA/Disabled/Vets

Hawai‘i Pacific Health offers a comprehensive and competitive total rewards package that includes pay and benefits. Rate of pay for selected candidates will be determined by various factors including knowledge, skills, abilities, relevant experience and training, as well as internal peer equity.