Internal Auditor, UC Cancer Center, Remote
Internal Auditor, UC Cancer Center, Remote
Founded in 1819, the University of Cincinnati ranks among the nation’s best urban public research universities. Home to more than 47,000 students, 10,500 faculty and staff and 330,000 alumni, UC combines a Top 35 research university with a physical setting The New York Times calls “the most ambitious campus design program in the country.”
With the launch of Next Lives Here, the Cincinnati Innovation District, a $100 million JobsOhio investment, eight straight years of record enrollment, worldwide leadership in cooperative education, a dynamic academic health center and entry into the Big 12 athletic conference, UC’s momentum has never been stronger. UC’s annual budget tops $1.6 billion and its endowment totals $1.9 billion.
As one of the oldest medical schools in the country, the UC College of Medicine has a reputation for training best- in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients.
The College of Medicine, UC Cancer Center is looking for an Internal Auditor. At the UC Cancer Center, our vision is to build a nationally recognized center that excels in cancer care, research, training and community impact and this role will serve as a key member of the Clinical Trials Office in support of these efforts.
Duties will focus primarily on auditing of adult oncology human subjects research activities for compliance with the research protocol, FDA regulations & ICH-GCP as well as coordination of internal audit training program and providing education to research staff and physicians. Applicants with research auditing, ICH-GCP, FDA regulations, or CRA/study monitoring experience are encouraged to apply. This will be a primarily remote-work position, but occasional travel to the University of Cincinnati Clinical Trials Office (~5% travel annually) will be required.
The incumbent will actively participate, plan, and evaluate multiple, complex and/or multi-faceted research programs for one or more designated departments, programs, or central units. Duties can span a broad range of activities or be primarily focused within one or more areas of the clinical research spectrum.
- Conducts routine and directed internal audits to ensure compliance with federal regulations as well as NCI requirements, and ICH-GCP.
- Writes timely detailed reports which support all audit findings with references to applicable regulations (FDA, ICH-GCP) the IRB approved protocol, institutional policies, UCCC SOPs and workflows.
- Serves as a knowledge expert on federal regulations (investigational drugs), ICH-GCP, UCCC SOPs and workflows; as well as on oncology-specific research topics (e.g., RECIST/RANO/Lugano, CTCAE & SAEs, NCTN, Clinical & Pathological Disease Staging).
- Provides ongoing professional communication to study teams to ensure their internal audit experience is educational, non-judgmental, and focused on improvement of current and future practices.
- Confirms whether study team corrective and preventive actions are adequate and verifies completion of corrective actions; assists in the writing of CAPAs as needed.
- Supports preparation efforts for, and participates in, external audits of UCCC CTO studies (FDA, NCTN Cooperative Groups, Industry Sponsored, UC HRPP).
- Utilizes and maintains systems for tracking and reporting of internal audit metrics, assists QA & Data Manager with the preparation of reports to stakeholders as needed.
- Develops and maintains and coordinates an internal audit training program – prepares mock source, quizzes (within Canvas or similar) and establishes metrics to verify staff and clinician knowledge of protocol & consent compliance, FDA regulations, ICH-GCP and institutional expectations.
- Conducts internal mock-audit training with new staff and clinicians, and updates on at least an annual basis for ongoing verification of existing staff knowledge.
- Provides reports to stakeholders about internal audit training program metrics.
- Attends Process Improvement Committee meetings and in collaboration with QA staff and Managers provides updates to internal SOPs and Workflows based on audit findings and staff training/educational needs.
Essential Functions Continued
- Assists in the initial development, writing and editing of IIT protocols through the IIT Committee. Assists with the validation and testing of EDC guides, forms and design in REDCap for IITs.
- Provides sponsor-investigator training to PIs in conjunction with other QA staff.
- Develops educational materials and presentations based on audit findings and trends and to maintain staff knowledge on core oncology and research best practices.
- Performs related duties based on departmental need. This job description can be changed at any time.
- Bachelor’s degree
- Nine (9) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.
Five (5) years related experience.
Additional Qualifications Considered
Experience in an academic or clinical setting in the area of clinical specialization. SoCRA or ACRP certification.
Physical Requirements/Work Environment
- Sitting - Continuously
Compensation and Benefits
UC offers a wide array of complementary and affordable benefit options, to meet the financial, educational, health, and wellness needs of you and your family. Eligibility varies by position and FTE.
- Competitive salary range dependent on the candidate's experience.
- Comprehensive insurance plans including medical, dental, vision, and prescription coverage. Flexible spending accounts and an award-winning employee wellness program, plus an employee assistance program.
- Financial security via our life and long-term disability insurance, accident and illness insurance, and retirement savings plans.
- Generous paid time off work options including vacation, sick leave, annual holidays, and winter season days in addition to paid parental leave.
- Tuition remission is available for employees and their eligible dependents. Enjoy discounts for on and off-campus activities and services.
If interested, please go to https://bit.ly/3Rz1X5n
The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.
As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).
The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / Minority / Female / Disability / Veteran.