Description

Title: Research Associate (Regulatory Associate – Clinical Trials Office) - POSN 0097280T - READVERTISEMENT
Position Number: 0097280T
Hiring Unit: RES & DEAN OF GRAD DIV, CANCER CT HI, CANCER CT HI
Location: Honolulu, Kaka'ako, O'ahu
Date Posted: May 28, 2024
Closing Date: July 12, 2024 at 11:59 P.M.
Band: B
Salary: salary schedules and placement information
Additional Salary Information: PBB; Minimum $5,000/Monthly
Full Time/Part Time: Full-time
Month: 11-month
Temporary/Permanent: Temporary

Duties and Responsibilities:

1. *Serves as the Regulatory Associate and single point of contact for assigned projects by creating and communicating a prioritization plan based on pipeline studies and project meeting discussion to the Regulatory Supervisor and Clinical Trials Administration.
2. *Partners with the Regulatory Supervisor to serve as an in-house regulatory expert to internal and external stakeholders.
3. *Authors high quality regulatory documents under minimal supervision for The University of Hawaii’s Cancer Center Clinical Trial Office (CTO), NCI Designated Trials, Industry and Investigator Initiated (IIT) clinical research trials. Essential documents to include, but are not limited to: FDA-1571, FDA-1572, IND, initial IRB application, local privacy board applications, sponsor required documents, and informed consent creation.
4. *Communicates, coordinates, and collaborates with consortium partners regarding site activation processes. Assures that all necessary tasks for study activation have been thoroughly completed and reviewed.
5. *Manages Trial Master Files (TMF), Investigator Site File (ISF) or applicable regulatory binder according to current FDA and Local guidelines. Similarly, updates the local share drive and Clinical Trial Management System (CTMS) OnCore to maintain continuity. Communicates and documents correspondences between study teams.
6. *Partners with the Regulatory Supervisor in an internal quality assurance review and provides evaluation and support where opportunities of improvement are identified.
7. *Assists study monitors, auditors, and quality assurance teams during routine visits or audits.
8. *Educates and presents regulatory related topics to the University of Hawaii Cancer Center and Regulatory staff. Topics of education will be directed by current quality assurance assessments, FDA or local regulatory standard operation updates, or identifiable training as identified by the Regulatory Supervisor/Manager.
9. *Maintains and sustains relationships by working closely with investigators, study team personnel, Hawai’i Cancer Consortium (affiliate healthcare consortium partners), and sponsors.
10. Other duties as assigned.

1. Possession of a baccalaureate degree in health or related field and three (3) years 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.
2. 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.
3. 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.
4. 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.
5. Demonstrated ability to interpret and present information and ideas clearly and accurately in writing, verbally and by preparation of reports and other materials.
6. Demonstrated ability to establish and maintain effective working relationships with internal and external organizations, groups, team leaders and members, and individuals.
7. Demonstrated ability to operate a personal computer, apply word processing software, interpret informed consent forms and Google Suite, Microsoft Office and Adobe Acrobat.
8. If applicable, for supervisory work, demonstrated ability to lead subordinates, manage work priorities and projects, and manage employee relations.

1. Experience in study start up
2. Experience in transitioning regulatory binders to e-Regulatory
3. Experience in Phase I Trials

EEO/AA, Clery Act, ADA

EEO/AA, Clery Act, ADA

The University of Hawai'i is an Equal Opportunity/Affirmative Action Institution and is committed to a policy of nondiscrimination on the basis of race, sex, gender identity and expression, age, religion, color, national origin, ancestry, citizenship, disability, genetic information, marital status, breastfeeding, income assignment for child support, arrest and court record (except as permissible under State law), sexual orientation, domestic or sexual violence victim status, national guard absence, or status as a covered veteran. For more information or inquiries regarding these policies, please refer to the following link: http://www.hawaii.edu/offices/eeo/eeo-coordinators/.

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/