Research Associate (Regulatory Associate) - (0097177T)

Research Associate (Regulatory Associate) - (0097177T)

Salary

$0.00 Semi-Monthly

Location

UH Manoa - UH Cancer Center, Kakaako - Honolulu, HI

Job Type

Full-Time Temporary

Job Number

2026-01969

Department

University of Hawaii at Manoa - University of Hawaii Cancer Center

Opening Date

09/14/2026

Closing Date

9/24/2026 11:59 PM Hawaii

Position Number:

0097177T

• Description
• Benefits

Description

Title: Research Associate (Regulatory Associate) - (0097177T)

Position Number: 0097177T

Hiring Unit: RES & DEAN OF GRAD DIV, CANCER CT HI, CANCER CT HI

Location: Honolulu, Kakako, Hawaii

Date Posted: September 14, 2026

Closing Date: September 24, 2026

Band: A

Salary: salary schedules and placement information

Additional Salary Information: PBA, minimum $4,627

Full Time/Part Time: Full-time

Month: 11-month

Temporary/Permanent: Temporary

Duties and Responsibilities:

• *Serves as the Regulatory Associate for the Clinical Trials Office (CTO), conducting, reviewing, and submitting clinical research studies through the study start-up process by preparing initial clinical research study applications and patient consent forms for submission to the respective Internal Review Board (IRBs) for local site activation of national cooperative group trials, pharmaceutical- sponsored trials, and investigator-initiated trials within the UH Cancer Center clinical trials network. Review all approved consents before studies are officially activated.

• *Maintains sponsor-written consent forms, log of local IRB reviews, protocol regulatory files of all IRB submissions and approvals, annual continuation renewal applications, sponsor amendments, and responds to IRB stipulations and inquiries to ensure document language is in compliance. Acts as a liaison with multiple IRBs.

• *Maintains data integrity by entering information accurately and timely in the Clinical Trials Management System (CTMS). Ensures appropriate research credentials are tracked and kept current for CTO staff, Translational Cancer Research (TCR) faculty and staff, and community investigators and staff.

• *Assist the Regulatory Supervisor with developing regulatory-related Clinical Research Regulatory Associate standard operating procedures, training, and documentation.

• *Assists frontline troubleshooting for all Hawaii Cancer Consortium/Network (i.e., community hospitals and clinics) staff at partnering institutions on regulatory-related issues.

• *Facilitates the review of Serious Adverse Events (SAEs) with research staff and PIs and communicates relevant SAE reports to IRBs.

• *Completes and maintains Delegation Task Logs when required by Sponsors and is responsible for regulatory duties on all ongoing clinical trials. Monitors the status of sponsor-issued protocol changes.

• *Contact study sponsors for assistance or seek additional information from the CTO Clinical Manager, principal investigators (PIs) and co-PIs, and other investigators regarding IRB queries.

• *Collaborates with CTO Clinical Manager, PIs, co-PIs, local PIs, lead Clinical Research Associates (CRAs), Compliance, Biocore, Investigator Initiative Trials (IIT) Manager, Protocol Coordinator, CTO Department Managers and Administrative staff, and other investigators for all IRB issues.

• *Partner with Compliance to maintain credentialing, audit preparation, and review of regulatory documents.

• *Works closely with UH HSR (Human Subjects Research), WIRB-Copernicus Group (WCG), Central Institutional Review Board, any other relevant IRBs, Office of Compliance, and IRB personnel from other Cancer Center programs, and Hawai`i Cancer Consortium institutions.

• *Communicates with the CTMS Manager and team for database changes, data quality assurance, and other CTMS tasks for accuracy to generate Clinical Research Regulatory Associate reports of clinical trial enrollments as mandated by the National Cancer Institute (NCI) and other sponsors.

• *Assists with maintaining an appropriate tracking system in CTMS for all protocol amendments/revisions and annual continuation renewals to ensure all federal regulations are met within the required parameters.

• Other duties as assigned.

• Denotes Essential Functions

Minimum Qualifications:

• Possession of a baccalaureate degree in health or related field and zero (0) year of progressively responsible professional experience with responsibilities for clinical research; or any equivalent combination of education and/or professional work experience which provides the required education, knowledge, skills and abilities as indicated.

• Functional knowledge of principles, practices and techniques in the areas of practical and potential value of health care research, research process and regulatory requirements (Human Subject protection, conflict of interest, research misconduct) and working knowledge of medical terminology demonstrated by the broad knowledge of the full range of pertinent standard and evolving concepts, principles and methodologies.

• Functional knowledge and understanding of applicable federal and state laws, rules, regulations and theories and systems associated with Clinical Research, regulatory protection program, regulatory procedures, HIPPA Compliance and regulations for research on human subjects.

• Demonstrated ability to recognize problems, identify possible causes and resolve the full range problems that may commonly occur in the area of Clinical regulatory, Institutional review board (IRB) protocols, Clinical trials management systems (CTMS), and Human Subjects.

• Demonstrated ability to understand oral and written documentation, write reports and procedures, and communicate effectively in a variety of situations.

• Demonstrated ability to establish and maintain effective working relationships with internal and external organizations, groups, team members and individuals.

• Demonstrated ability to operate a personal computer, apply work processing software, interpret informed consent forms and Google Suite, Microsoft Office and Adobe Acrobat.

Supplemental Qualifications:

• Familiar with clinical trials and informed consent process.

Desirable Qualifications:

• Demonstrated ability to work independently and take initiative on various projects.

• General knowledge of the University of Hawaii (UH) regulatory systems, research grants, and preparation of proposals and reports.

To Apply: Click on the "Apply" button on the top right corner of the screen and attach the required documents. Applicants must submit 1) cover letter indicating how you satisfy the minimum and desirable qualifications, 2) resume, 3) names and contact information of three (3) professional references and 4) official transcripts (OR original documentation from the institution confirming degree OR copy of U.S. board certification). Copy of transcript is acceptable in place of U.S. board certification for evaluation purposes but original is required upon hire. Transcripts issued outside the United States of America require a course-by-course analysis with an equivalency statement from an agency having membership with the National Association of Credential Evaluation Services, Inc., verifying the degree equivalency to that of an accredited institution within the USA will be required before date of hire. Expense of the evaluation shall be borne by the applicant (Note: Only complete applications will be considered.)

NOTE: If you have not applied for a position before using NEOGOV, you will need to create an account.

Inquiries: hr@cc.hawaii.edu

EEO, Clery Act, ADA

The University of Hawaii is an Equal Opportunity Institution and is committed to a policy of nondiscrimination in employment, including on the basis of veteran and disability status. For more information, visit: https://www.hawaii.edu/offices/eeo/policies/

Employment is contingent on satisfying employment eligibility verification requirements of the Immigration Reform and Control Act of 1986; reference checks of previous employers; and for certain positions, criminal history record checks.

In accordance with the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act, annual campus crime statistics for the University of Hawaii may be viewed at: https://www.hawaii.edu/titleix/help/campus-security/, or a paper copy may be obtained upon request from the respective UH Campus Security or Administrative Services Office.

In accordance with Article 10 of the unit 08 collective bargaining agreement, bargaining unit members receive priority consideration for APT job vacancies. As a result, external or non BU 08 applicants may not be considered for some APT vacancies. BU 08 members with re-employment rights or priority status are responsible for informing the hiring unit of their status.

Accommodation Request: The University of Hawaii complies with the provisions of the Americans with Disabilities Act (ADA). Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the EEO coordinator directly. Determination on requests for reasonable accommodation will be made on a case-by-case basis. For further information, please refer to the following link: https://www.hawaii.edu/offices/eeo/accommodation-request/

YOUR JOB BENEFITS WITH THE UNIVERSITY OF HAWAII

The University of Hawaii is committed to providing benefits that matter to you at each stage of your employment. In addition to competitive salary, we offer a wide variety of resources and benefits programs to our employees, such as a comprehensive health care insurance, pension/retirement program, life insurance, supplemental retirement savings plans, vacation leave, sick leave, paid holidays, child care assistance and education assistance programs. To view a summary of the employee benefits, please visit: https://www.hawaii.edu/ohr/documents/2054/ or for more detailed information, please visit: http://www.hawaii.edu/ohr/faculty-staff/benefits

Employer University of Hawaii

Department University of Hawaii at Manoa - University of Hawaii Cancer Center Address 701 Ilalo Street

Honolulu, Hawaii, 96813

Website http://workatuh.hawaii.edu