Research Compliance Administrator I (College of Medicine - Phoenix)
Posting Number: req12167
Department: COM Phx Internal Medicine
Location: Greater Phoenix Area
Address: 475 N 5th St, Phoenix, AZ 85004 USA
The Clinical Research Compliance Team is a functional component of the Internal Medicine centralized clinical trials unit that is organized to provide support for new and ongoing efforts in clinical research at the College of Medicine Phoenix. This Research Compliance Administrator I position will provide dedicated administrative support to research investigators and staff to ensure compliance to regulatory requirements for conducting clinical trials. This employee will have consistent contact with investigators, clinical research staff, sponsors, UA Human Subjects Protection Program (IRB), institution departments (compliance, research administration offices) and administrative staff. It is expected that this person will have knowledge regarding clinical research practices and regulatory requirements.
The University of Arizona College of Medicine - Phoenix anchors the 28-acre Phoenix Biomedical Campus in the heart of the Valley of the Sun. The College inspires and trains individuals to become exemplary physicians, scientists and leaders who are life-long learners and inquisitive scholars. The Phoenix Biomedical Campus embodies the University's priorities of engagement, partnership, innovation, and synergy in its world-class academic and research initiatives, with clinical facilities throughout Greater Phoenix.
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!
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Duties & Responsibilities
- Prepare and/or coordinate submission
of new protocols (drug/device, industry sponsored, investigator-initiated,
national cooperative group) for approval on internal and other committee reviews,
IRB review, and other regulatory agency review.
- Prepare and/or coordinate
submission of protocol amendment and other revisions, prompt reports, new
information, progress reports for approval for assigned studies.
- Coordinate regulatory activities
relating to clinical trial start up and study conduct for the duration of the
- Prepare, coordinate, and maintain
regulatory documentation required by regulatory agencies and sponsors.
- Maintain continuous
communication with study teams to ensure research compliance and documentation
throughout study duration.
- Update and maintain clinical
trial management system with study status and regulatory documentation.
technical and regulatory advice and trainings (individual and group) to
investigators and study staff in the areas of research compliance and
- Participate in monitoring and
auditing activities to ensure compliance with policies, regulations, protocols
and SOPs, as needed.
- Participate in the development and
implementation of compliance processes and procedures, as needed.
- Assist and/or conduct study
initiation, interim monitoring and close-out visits for Investigator-initiated
clinical research trials.
- Serve as a liaison for answering role
related and compliance process related questions.
- Other duties as assigned
Knowledge, Skills, and Abilities
- Strong organizational, administrative, communication, and interpersonal skills required
- Proficient computer skills with Internet and MS Office (Outlook, Word, Excel etc.) and online tools
- Bachelor's Degree and one (1) year relevant professional
level work experience; OR
- Associates Degree and three (3) years relevant work experience
* Bachelor's degree in a related field of study.
* Clinical Research experience.
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: $42,620 - $55,833 Annually
Compensation Type: salary at 1.0 full-time equivalency (FTE)
Career Stream and Level
Type of criminal background check required: Name-based criminal background check (non-security sensitive)
Number of Vacancies: 1
Contact Information for Candidates
College of Medicine-Phoenix, Office of Human Resources
Open Until Filled: Yes
Documents Needed to Apply: Resume and Cover Letter
Special Instructions to ApplicantApplication: The online application should be completed in its entirety. Blank or missed information may be considered an incomplete submission.
Letter of Interest: Should clearly indicate how your skills and professional employment experience meet the Minimum and the Preferred qualifications (if applicable).
At the University of Arizona, we value our inclusive climate because we know that diversity in experiences and perspectives is vital to advancing innovation, critical thinking, solving complex problems, and creating an inclusive academic community. As an Hispanic-serving institution, we translate these values into action by seeking individuals who have experience and expertise working with diverse students, colleagues, and constituencies. Because we seek a workforce with a wide range of perspectives and experiences, we provide equal employment opportunities to applicants and employees without regard to race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or genetic information. As an Employer of National Service, we also welcome alumni of AmeriCorps, Peace Corps, and other national service programs and others who will help us advance our Inclusive Excellence initiative aimed at creating a university that values student, staff and faculty engagement in addressing issues of diversity and inclusiveness.