Research Associate, Senior (Investigator Initiated Trials [IIT]/Protocol Lead) - (0097712T)

University of Hawaii•Kaka'ako - Honolulu, HI

9d•Onsite

About The Position

Serves as the lead for National Cancer Institution (NCI)-funded study, Industry-sponsored study, and Investigator Initiated Trials (IITs) across clinical trial venues to develop, implement and monitor all protocols for the UH Cancer Center Clinical Trials Office (CTO). Track and facilitate a diverse portfolio of protocols through every stage of the review and approval process, including the Disease Site Working Group (DSWG) discussion, Protocol Review and Monitoring Committee discussion, Regulatory process (for IIT), and Institutional Review Board (IRB). Organize and manage tasks to ensure the timely activation and opening of new clinical trials. Facilitate activation processes with external partners (e.g., Hawaii Cancer Consortium sites, pharmaceutical, diagnostic, and biotech companies, and federal agencies) and coordinate scientific feasibility reviews during the Protocol Review and Monitoring System process. Coordinate Confidential Disclosure Agreement (CDA)/ Non Disclosure Agreement (NDA) process with UH Office of Research Services. Facilitate Protocol Review and Monitoring Committee (PRMC) meetings, IIT meetings and Community Research Advisory Board (CRAB) meetings with CTO Medical Director and National Cancer Institute Community Oncology Research Program (NCORP) leaderships. Create a monthly ongoing protocol list with the CTMS team and distribute to the investigators and community. Provide professional protocol writing services to assist UH cancer center investigators in translating research concepts into fully articulated clinical research protocols. Ensure documents are formatted and structured according to institutional templates and industry standards. Author, develop, and revise patient informed consent forms in collaboration with the regulatory team, ensuring complex scientific concepts are translated into clear, understandable language for participants. Manage the writing and formatting of protocol amendments, updates, and continuing review documents throughout the lifecycle of the trial. Provide oversight, direction, and guidance to CTO personnel involved in IIT operations, including Clinical Research Associates (CRAs), administrative, and regulatory personnel. Mentor, train, and provide education for research support staff on clinical trial activation, implementation, and data fulfillment requirements. Partner closely with Principal Investigators (PIs), the CTO Medical Director, and the clinical venue's research staff to manage trial logistics, resolve operational issues. Maintain electronic tracking of all clinical trials communication during study startup. Ensure key tracking information is accurately entered into the OnCore Clinical Trial Management System (CTMS) in a timely manner. Collaborate with the CTMS team to resolve data capture, storage, and access issues. Oversee aspects of the Investigational New Drug (IND) management process if the protocol included the IND. Monitor and document the protocol review process in alignment with NIH/NCI guidelines. Prepare progress reports on IITs for sponsoring entities and the FDA. Conduct annual monitoring of protocol accrual with the PRMC, coordinate with investigators to increase accrual, and support internal auditing and monitoring alongside the Compliance Office. Maintain complete and detailed records of protocols at all stages, including new submissions, amendments, deviations, and continuing reviews. Perform other duties as assigned.

Requirements

Possession of a baccalaureate degree in Nursing, Science, Business Administration or health care or related field and five (5) years of progressively responsible professional experience with responsibilities for clinical research, oncology, basic/clinical research or health care; or any equivalent combination of education and/or professional work experience which provides the required education, knowledge, skills and abilities as indicated.
Considerable working knowledge of principles, practices, techniques in the area of methods and procedures in health care research, medical terminology, CTMS, Electronic Medical Records (EMRs) and/or oncology/general medicine concepts and clinical trials process.
Considerable working knowledge and understanding of applicable federal and state laws, rules regulations and theories and systems associated with clinical trial management, clinical research study performance and human subject protection (HIPAA compliance, conflict of interest, and research misconduct).
Demonstrated ability to resolve wide ranging complex problems through the use of creative reasoning and logic to accurately determine the cause of the problems and the resolution of the problems in an effective, innovative and timely manner.
Demonstrated ability to interpret and present information and ideas clearly and accurately in writing, verbally and by preparation of reports and other materials.
Demonstrated ability to establish and effective working relationships with internal and external organizations, groups, team leaders and members, and individuals.
Demonstrated ability to operate a personal computer, apply word processing software, Google Suite, Microsoft Office Suite (including Excel and PowerPoint), Adobe Acrobat, and Electronic Medical Records (EMRs).
If applicable, for supervisory work, demonstrated ability to lead subordinates, manage work priorities and projects, and manage employee relations.

Nice To Haves

Demonstrated knowledge in clinical trials, oncology research, and healthcare systems.
Demonstrated ability to interact positively with clinical study participants and others involved with the research environment.
Direct experience with clinically oriented program design and the analysis of clinical trials in cancer treatment.
Master's Degree from an accredited college or university in a health-related field, such as Nursing, Medical Records, Medical Technology or Pharmacology.
Working knowledge of the University of Hawai'i (UH), the RCUH, and UHCC policies and procedures.
Working knowledge of Clinical Trials Management Systems (preferably OnCore).
Previous work experience in a biomedical, health sciences, and/or university environment.

Responsibilities

Serve as the lead for NCI-funded study, Industry-sponsored study, and Investigator Initiated Trials (IITs) across clinical trial venues to develop, implement and monitor all protocols for the UH Cancer Center Clinical Trials Office (CTO).
Track and facilitate a diverse portfolio of protocols through every stage of the review and approval process, including the Disease Site Working Group (DSWG) discussion, Protocol Review and Monitoring Committee discussion, Regulatory process (for IIT), and Institutional Review Board (IRB).
Organize and manage tasks to ensure the timely activation and opening of new clinical trials.
Facilitate activation processes with external partners (e.g., Hawaii Cancer Consortium sites, pharmaceutical, diagnostic, and biotech companies, and federal agencies) and coordinate scientific feasibility reviews during the Protocol Review and Monitoring System process.
Coordinate Confidential Disclosure Agreement (CDA)/ Non Disclosure Agreement (NDA) process with UH Office of Research Services.
Facilitate Protocol Review and Monitoring Committee (PRMC) meetings, IIT meetings and Community Research Advisory Board (CRAB) meetings with CTO Medical Director and National Cancer Institute Community Oncology Research Program (NCORP) leaderships.
Create a monthly ongoing protocol list with the CTMS team and distribute to the investigators and community.
Provide professional protocol writing services to assist UH cancer center investigators in translating research concepts into fully articulated clinical research protocols.
Ensure documents are formatted and structured according to institutional templates and industry standards.
Author, develop, and revise patient informed consent forms in collaboration with the regulatory team, ensuring complex scientific concepts are translated into clear, understandable language for participants.
Manage the writing and formatting of protocol amendments, updates, and continuing review documents throughout the lifecycle of the trial.
Provide oversight, direction, and guidance to CTO personnel involved in IIT operations, including Clinical Research Associates (CRAs), administrative, and regulatory personnel.
Mentor, train, and provide education for research support staff on clinical trial activation, implementation, and data fulfillment requirements.
Partner closely with Principal Investigators (PIs), the CTO Medical Director, and the clinical venue's research staff to manage trial logistics, resolve operational issues.
Maintain electronic tracking of all clinical trials communication during study startup.
Ensure key tracking information is accurately entered into the OnCore Clinical Trial Management System (CTMS) in a timely manner.
Collaborate with the CTMS team to resolve data capture, storage, and access issues.
Oversee aspects of the Investigational New Drug (IND) management process if the protocol included the IND.
Monitor and document the protocol review process in alignment with NIH/NCI guidelines.
Prepare progress reports on IITs for sponsoring entities and the FDA.
Conduct annual monitoring of protocol accrual with the PRMC, coordinate with investigators to increase accrual, and support internal auditing and monitoring alongside the Compliance Office.
Maintain complete and detailed records of protocols at all stages, including new submissions, amendments, deviations, and continuing reviews.
Perform other duties as assigned.