Company: The University of Arizona Job Location: Tucson, Arizona Category: Assessment, Accreditation, and Compliance Type: Full-Time Posting Number: req26765 Department: Cancer Center Division Location: Tucson Campus Address: 1515 N Campbell Ave, Tucson, AZ 85724 USA Position Highlights This Regulatory Coordinator position will provide dedicated clinical trials administration support for ongoing and new developmental efforts in cancer clinical trials research. This position works closely with…
clinical faculty and their disease team. This selected candidate will have regular contact with the University of Arizona Human Subjects Protection Program (IRB), investigators, clinical research staff (nurses, data managers), clinical trials sponsors (e.g. private industry and national cooperative groups), and administrative staff. It is expected that this person will have or develop a knowledge base of the disease areas assigned and current management principles and will be able to serve in a consulting role to new faculty and staff regarding policies and procedures for clinical research. Visa sponsorship is not available for this positions. Outstanding U of A benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; U of A/ASU/NAU tuition reduction for the employee and qualified family members; retirement plans; access to U of A recreation and cultural activities; and more! The University of Arizona has been recognized for our innovative work-life programs. For more information about working at the University of Arizona and relocations services, please click here . Duties & Responsibilities Prepare and/or coordinate IRB and other required submissions and approvals of new phase I-III and other protocols for industry, investigator-initiated, and national cooperative group studies in assigned program area(s). Prepare and/or coordinate IRB and other required submissions of protocol amendments and other revisions, IND safety reports, and progress reports for approval for assigned studies. Coordinate other regulatory activities pertaining to clinical trial start-up. Conduct compliance reviews, end-of-study monitoring, and audit activities for assigned studies to verify adherence to institutional policies, federal regulations, and study-specific protocols and SOPs. Support new employees by demonstrating proper work practices, adhering to established institutional process & policy. Prepare, coordinate, and maintain regulatory compliance and related documentation required by regulatory agencies and sponsors. Update the clinical trials management system (CTMS) with respect to study status and actions. Provide regulatory advice and training on routine items to colleagues in assigned program area(s). Actively participate in assigned program area(s) by scheduling and preparing agendas and minutes for program area meetings. On an as-needed basis, review routine submissions and other assignments for quality assurance. Participate in the development and implementation of procedures and processes within the regulatory office. Assist in drafting and editing regulatory instructional materials. Other duties as assigned. Knowledge, Skills, and Abilities: Excellent technical writing skills. Demonstrated strong interpersonal, communication, and problem-solving skills. Excellent organizational skills. Knowledge of MS Word (word processing) and Excel. Knowledge of medical oncology terminology and treatment concepts. Familiarity with University of Arizona and Federal policies and procedures for protection of human subjects. Previous experience with national cooperative group and private industry cancer clinical research. Minimum Qualifications Bachelor's degree or equivalent advanced learning attained through professional level experience required. Minimum of 3 years of relevant work experience, or equivalent combination of education and work experience. This job posting reflects the general nature and level of work expected of the selected candidate(s). It is not intended to be an exhaustive list of all duties and responsibilities. The institution reserves the right to amend or update this description as organizational priorities and institutional needs evolve. Position Details FLSA: Exempt Full Time/Part Time: Full Time Number of Hours Worked per Week: 40 Job FTE: 1.0 Work Calendar: Fiscal Job Category: Research Benefits Eligible: Yes - Full Benefits Rate of Pay: $53,039 - $66,299 Compensation Type: salary at 1.0 full-time equivalency (FTE) Grade: 7 Career Stream and Level: PC2 Job Family: Research Compl Job Function: Research Type of criminal background check required: Name-based criminal background check (non-security sensitive) Number of Vacancies: 1 Open Until Filled: Yes Compensation Guidance The Rate of Pay Field represents the University of Arizona's good faith and reasonable estimate of the range of possible compensation at the time of posting. The University considers several factors when extending an offer, including but not limited to, the role and associated responsibilities, a candidate's work experience, education/training, key skills, and internal equity. The Grade Range represent a full range of career compensation growth over time. The university offers compensation growth opportunities within its career architecture. To learn more about compensation, please review our Applicant Compensation Guide and our Total Rewards Calculator . Contact Information for Candidates Brianna Denton, briannadenton@arizona.edu Documents Needed to Apply Resume and Cover Letter Special Instructions to Applicant Application: The online application should be completed in its entirety. Blank or missed information may be considered an incomplete submission. Cover Letter: Should clearly indicate how your skills and professional employment experience meet the Minimum and the Preferred qualifications (if applicable).
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