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Job Details

Research Support Human Subject Compliance Director

Honolulu, HI

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Hiring Unit:
**MEMBERS ONLY**SIGN UP NOW***. Cancer Center
Date Posted:
July 12, 2018
Closing Date:
August 14, 2018
Minimum Monthly Salary:
salary schedules and placement information
Full Time/Part Time:
Full Time
Temporary - Not to Exceed: June 30, 2020
Other Conditions:
Position to approximately start in Fall of 2018.
Duties and Responsibilities
Serves as the UH Cancer Center (UHCC) Human Subjects Compliance Director providing overall leadership, planning, & direction on all human subjects related federal & local regulations & grant/contract obligations including reporting requirements.
Supervises the Human Subjects Research Compliance Specialist.
Develops and implements corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.
Ensures that all clinical trials have been reviewed, properly documented and approved by the Data and Safety Monitoring Committee (DSMC). Ensures records are maintained and updated.
Assures compliance with the UH Human Studies Program & HIPAA Compliance Office, DSMC, Clinical Trials Reporting Program (CTRP), privacy of protected health information & other NCI CCSG P30 human subjects research reporting requirements.
Responsible for the planning, development, implementation and monitoring of the Center’s Human Subjects Research Compliance Program.
Responsible for conducting random internal audits on a minimum of 10% of the institutionally-generated clinical trials that the DSMC is monitoring and 5% of the cooperative group trials that are reviewed (con't.)
(con't.) by Protocol Review and Monitoring System (PRMS) as part of the Center’s DSMP, & other research projects of the Center to ensure compliance with state & federal regulatory agencies, and institutional policies related to human subjects research.
Serves as Center’s liaison with local & federal regulatory agencies, UH Human Subjects Prg, UH HIPAA Compliance Off, NCI Central Institutional Review Board , affiliate hospital IRBs, the Western IRB, & federal Office for Human Subject Protection (OHRP).
Communicates with Principal Investigators and Medical Director of the Clinical Trials Office (CTO) for direction and assistance on any problematic clinical or regulatory compliance matter.
Ensures annual reporting of Data Tables 3 and 4 for the National Cancer Institute (NCI) P30 Cancer Center Support Grant.
Participates and cooperates in all external audits performed by external regulatory agencies. Ensures that the required research documentation measures are met.
Serves as a member of the clinical research team in developing and implementing quality standards, methods, and procedures to facilitate overall research compliance.
Recommends, develops, coordinates, and participates in multifaceted educational and training programs especially the mandatory training requirements that focus on the elements of the compliance program.
Ensures that senior management and all appropriate employees are knowledgeable of, and comply with pertinent federal and state standards.
Identifies potential areas of compliance vulnerability and risks, and reports them to the Center’s leadership.
Collaborates with UHCC senior management to develop, implement, review, revise, & provide oversight of the standard operating procedures (SOP) of the CTO & (con't.)
(con't.) clinical trials support of the HI Cancer Consortium (HCC) through routine audits as defined in the Data & Safety Monitoring Plan (DSMP).
Implements Quality Assurance (QA) programs to prevent regulation compliance violations in clinical research.
Maintains a master file of contracts executed for research supported by Center Clinical Trials Office and monitors compliance with deliverables and maintains the record-keeping and coordination of the Center‘s DSMP.
Provides guidance to participating sites on QA processes; acquires info on all external audits performed by NCI cooperative groups, sponsors & agencies & assures corrective action plans are drafted & implemented to address any deficiencies noted.
Other duties as assigned
Minimum Qualifications
Possession of a baccalaureate degree in a health care field such as nursing or medicine and 7 year(s) of progressively responsible professional experience with responsibilities for human subjects with an understanding of federal and local requirements for research in a healthcare organization with demonstrated leadership ability. Experience in contract administration and compliance; or equivalent education/training or experience.
Advanced and comprehensive knowledge and understanding of a wide range of developing and emerging concepts, principles and methodologies of the assigned working knowledge of federal and local regulations dealing with human subjects. Understanding of human subject research with knowledge of medical terminology..
Comprehensive knowledge and understanding of a wide range of principles, theories, federal and state laws and systems associated with knowledge of regulations governing healthcare industry.
Demonstrated ability to understand problems from a broad interactive perspective and use reasoning to discern underlying principles and issues when problem solving, and apply creative thinking to resolve problems in new and unprecedented approaches.
Demonstrated written and verbal competence in presenting ideas, concepts and models clearly using persuasion and negotiation to build consensus and cooperation.
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 and apply word processing software.
For supervisory work, demonstrated ability to lead subordinates, manage work priorities and projects, and manage employee relations.
Any equivalent combination of education and/or professional work experience which provides the required education, knowledge, skills and abilities as indicated.
Strong organizational skill and demonstrated ability in problem-solving. Must have strong leadership skills, such as confidence and resiliency.
Demonstrated ability to interpret medical records and clinical research protocols.
Must possess Certification as Clinical Research Professional, Clinical Research Coordinator or in Health Care Compliance & maintain throughout employment. If not certified then certification must be obtained within first 12 months of employment.
Desirable Qualifications
Master's degree in health care field such as nursing or medicine.
Knowledge of the UH Cancer Center, Research Corporation of the **MEMBERS ONLY**SIGN UP NOW***. and UH procedures and policies.
Knowledge of oncology research and study management.

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