The University of Arizona Cancer Center (UACC) is a National Cancer Institute-designated comprehensive cancer center dedicated to the prevention and cure of cancer through patient care, research, and education. The UACC is seeking candidates for two Investigator Initiated Trial (IIT) Manager positions. The IIT Manager contributes to the organization, development, and sponsor management activities of clinical research investigator initiated trials and UACC NCI program coordination and reporting. This position collaborates with researchers physicians and research collaborators, cancer center shared resources, and CTO leadership. The successful candidate will help develop protocol reports and provide sponsor management activities including appropriate communication with all participating sites as well as UA and UACC oversight committees. The IIT Manger will also support for UACC NCI program coordination to ensure institutional compliance with reporting clinical trial data to CTRP, CT.Gov, and NCTN reporting as assigned.
Outstanding UA benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; state and optional retirement plans; access to UA 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
Work with clinical research physicians in the development of new clinical research IITs. Including but not limited to: protocol development; consent forms; funding proposals; case report forms; and other ancillary material (i.e., research subject telephone scripts, instructional guides, and research manuals) and revise/amend existing documents as necessary. This role will assist the research PI in contributing materials, prepare reports, and assist in the writing of research findings for papers, presentations, and other documents. Write and review investigator-generated scientific journal articles and identifying gaps in IIT trial documentation, analyze and propose solutions.
Meet project goals and deadlines and serve as the primary sponsor contact for affiliate sites participating in IITs assigned. Provide sites all appropriate site trial documentation and ensure the collection of essential information for reporting purposes. This role will act as the administrative trial support for all multi-center IITs assigned including working closely with the UACC coordinating center PI, ensuring all trial specific meetings are effectively managed (including set up, developing agendas, taking minutes, and distributing meeting materials to all participants), and trial related reports are prepared as requested by the trial PI.
Provide primary sponsor oversight management activities for non-multi-center IITs assigned. This will include:
Provide support for resolving operational, workload, protocol implementation, and data collection issues.
Develop and/or coordinate the database specifications, edit check specifications, and the development of a documented trial data management plan, conduct data reviews, query generation/resolution, data reconciliation, and help identify protocol deviations.
Provide input into IITs assigned to ensure the data collection requirements are clear and supportive of the study endpoints.
Support CTRP and CT.Gov coordination and reporting requirements for UACC as assigned.
Support UACC NCTN coordination assignments.
Keep current on legislation, rules, regulations, and polices; help educate physicians and staff regarding changes as related to clinical research protocol design, informed consent form requirements, and research grant writing requirements.
Knowledge, Skills, and Abilities
Understands clinical research process and regulatory requirements.
Identify and understand the need for standardization and takes initiative to help improve efficiency.
Advanced knowledge of data management processes and industry standards.
Multi-disciplinary knowledge across research industry functional areas.
Fundamental knowledge of adverse event and medication coding dictionaries.
Experience with MS Word, Excel and PowerPoint.
Experience demonstrating project management capabilities.
Data Analysis and data set management.
Effective communication skills both verbal and written.
Ability to work independently with minimal supervision and accountable for managing multiple studies concurrently.
Minimum of 5 years of relevant work experience is required.
Bachelor's degree or equivalent advanced learning attained through professional level experience required.
Preferred Qualifications *Bachelor’s degree in science or related field. * Masters/Doctoral degree. * Research experience, including protocol design, informed consent form development, EDC/RDC technology, and/or successfully technical scientific writing or document development. *Experience writing clinical trials for cancer research.
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 $53,946 - $75,896
Compensation Type salary at 1.0 full-time equivalency (FTE)
Career Stream and Level PC3
Job Family Research Program Admin
Job Function Research
Type of criminal background check required: Name-based criminal background check (non-security sensitive)
Number of Vacancies 2
Target Hire Date
Expected End Date
Contact Information for Candidates Chad Adams
Open Date 9/21/2021
Open Until Filled Yes
Documents Needed to Apply Resume and Cover Letter
Special Instructions to Applicant Application: The online application should be completed in its entirety.