PS Project Administrator
Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve which includes Idaho, Montana, Nevada, Utah, and Wyoming with impact worldwide. In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities.
Oversees all administrative, financial, personnel, and technical functions of a program in an assigned department. Organizes and assigns duties to employees and advises the departmental administrators of the program's activities.
Responsibilities :
- Supports Principal Investigators (PI) and study management staff with patient screening / enrollment, eligibility review, data submission, and overall maintenance of new and ongoing clinical trials.
- Ensures study management staff are providing quality source documents and data to sponsors, while ensuring protocol compliance is maintained within regulatory guidelines and standards.
- Routinely monitor and ensure compliance with eligibility, protocol requirements, data submission completion while monitoring delinquency rates, outstanding query resolutions.
- Ensure monitoring / auditing reports and outstanding issues with staff are identified, addressed, and resolved in appropriate timeframe while providing direction and oversight.
- Provides assistance with personnel management and supervision, while mentoring and training new or junior research staff and providing adequate team coverage plans.
- Contribute to developing educational materials on coordination and data completion processes and requirements for the teams, as well as evaluation and education tools to assess staff competency.
- Assist with study start-up and oversee workload resourcing for team while providing primary point of contact support for completion of start-up activities.
- Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs).
- Oversee and ensure completeness in appropriate AE and SAE reporting requirements as well as Deviation reporting to sponsors and the IRB.
- Manages the workflow by reviewing staff performance through period performance and salary reviews and revising the operating procedures as needed.
- Assume responsibility for additional assignments as directed by the Program Manager.
Work Environment and Level of Frequency Typically Required :
Nearly Continuously : Office environment.Nearly Continuously : Sitting, hearing, listening, talking.Often : Repetitive hand motion (such as typing), walking.Seldom : Bending, reaching overhead.Minimum Qualifications :
Bachelor's degree in Business Administration, Accounting, or a related field, or equivalency (one year of education can be substituted for one year of related work experience); four years of progressively more responsible related experience; and demonstrated human relation and effective communications skills required. A related Master's degree preferred.Preferences :
Bachelor's degree in a related area of assignment or equivalency and 4 6 years of progressively more responsible oncology experience.Background knowledge of assigned department's area of specialization in order to analyze, plan, train and draw conclusions for recommendations to Clinical Trial Manager. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop team and to ensure the smooth operation of department.Completion of provided supervisory / management training within one year of employment may be required.Three years of Oncology Clinical Research Coordinator Experience.Advanced knowledge and understanding of regulatory guidelines related to human subject research protections in clinical trial investigations.Clinical Trial Management Software experience.Ability to assess functional processes, workflow and develop improvements for efficiency and quality output.Advanced knowledge of industry standards related to clinical trial coordinator functions and study data management activities.Demonstrated ability to positively influence others in a team environment.The University of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients. All qualified individuals are strongly encouraged to apply. Veterans' preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities. The University of Utah is an Affirmative Action / Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran's status.