What are the responsibilities and job description for the Research Associate (Investigator-Initiated Trials Coordinator) position at University of Hawaii?
Description
Title: Research Associate (Investigator-Initiated Trails Coordinator) - (0097328T)
Position Number: 0097328T
Hiring Unit: RES & DEAN OF GRAD DIV, CANCER CT HI, CANCER CT HI
Location: Honolulu, Kaka'ako, Hawai'i
Date Posted: February 18, 2025
Closing Date: March 10, 2025 at 11:59 P.M.
Band: B
Salary: salary schedules and placement information
Additional Salary Information: PBB, minimum $5,250/month
Full Time/Part Time: Full-time
Month: 11-month
Temporary/Permanent: Temporary
Duties and Responsibilities
- Serves as the coordinator of Investigator-Initiated Trials (IIT) for the Clinical Trials Office (CTO) and clinical trial venues to develop, implement, conduct, manage and monitor all IITs.
- Organizes and manages activities and tasks associated with the conduct of cancer clinical trials to ensure timely and accurate opening and coordination of IITs.
- Provides oversight and direction for CTO personnel involved in IIT operations - Clinical Research Associates (CRAs), OnCore Clinical Trial Management System [CTMS], BioCore, Protocol Coordinator, administrative, and regulatory personnel.
- Acts as a liaison between CTO and external partners including clinical trial venues, sponsors, federal agencies to collaborate seamlessly during the entire study process.
- Collaborates with the CTO Principal Investigators (PI)s, CTO Medical Director and the CTO Clinical Director/Early Phase Clinical Research Center (EPCRC) Clinic Manager with clinical trial and protocol development as a part of the Protocol Development Team; as well as tracking the IIT budget and expenditures in cooperation with CTO administrative/fiscal staff.
- Prepares progress reports on IITs in collaboration with the PI, as required by sponsoring entities and the US Food and Drug Administration.
- Works with PIs and CTO staff to ensure oversight of all protocol data collection, including completing initial study, treatment, and follow-up forms.
- Collaborates with PIs for overall logistics for IIT projects and resolves issues. Oversees aspects of the Investigational New Drug (IND) application process, including initial and follow-up submissions.
- Provides guidance to those CRAs assigned to supporting enrollment of eligible participants to IITs and ensures data requirements for all IITs are fulfilled.
- Ensures all patient tracking information is entered into OnCore CTMS and/or other required data capture system in a timely manner. Reviews data for accuracy and submits data within time requirements, electronically if required.
- Works closely with the OnCore CTMS team to identify and manage IIT issues related to IIT data capture, storage, and access.
- Works with the CTO Clinical Director/EPCRC Clinic Manager in coordination with the UHCC Compliance Office to facilitate internal auditing and monitoring of IITs and provides reports to the Data Safety Monitoring Committee (DSMC).
- Coordinates monthly Translational Clinical Research (TCR) meetings and IIT meeting with clinical faculty to review IITs, grant submissions, and other planned projects.
- Facilities protocols through the Protocol Review Monitoring System, especially those IIT-related. Participates in the development of the Protocol Review Monitoring Committee and Community Research Advisory Board meetings. Supports the CTO Protocol Coordinator with study start up activities, as appropriate.
- Performs other duties as assigned.
- Denotes essential functions
Minimum Qualifications
- Possession of a baccalaureate degree in health or related field and three (3) years of progressively responsible professional experience with responsibilities for basic or 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 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.
- Considerable working 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 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 maintain 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, interpret informed consent forms and Google Suite, Microsoft Office and Adobe Acrobat.
- If applicable, for supervisory work, demonstrated ability to lead subordinates, manage work priorities and projects, and manage employee relations.
Supplemental Minimum Qualifications
- Previous work experience in biomedical, health sciences, and/or university environment.
Desirable Qualifications
- Experience with a clinically orientated program design and analysis of clinical trials in cancer treatment.
- Experience with University of Hawaii, Research Corporation of the University of Hawaii (RCUH) policies and procedures.
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Inquiries:hr@cc.hawaii.edu
EEO, Clery Act, ADA
The University of Hawai'i 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 Hawai'i 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 Hawai'i 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/
Salary : $5,250
