Research Associate; Regulatory Associate

Research Associate (Regulatory Associate) - (0097177T) | University of Hawai'i page has loaded.

Full-Time Temporary

Job Number

University of Hawai'i at Manoa - University of Hawai'i Cancer Center

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

Position Number: 0097177T

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

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.

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