Job Information
University of Utah Theranostics Project Administrator in Salt Lake City, Utah
Details
Open Date 08/22/2024
Requisition Number PRN39633B
Job Title PS Project Administrator
Working Title Theranostics Project Administrator
Job Grade F
FLSA Code Administrative
Patient Sensitive Job Code? Yes
Standard Hours per Week 40
Full Time or Part Time? Full Time
Shift Day
Work Schedule Summary
VP Area President
Department 01167 - HCI Clinical Trials Operations
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 47600 to 74609
Close Date
Open Until Filled Yes
Job Summary
The Huntsman Cancer Institute Clinical Trials Office ( CTO ) is hiring a Theranostics Project Administrator who will play a pivotal role in assisting with the oversight and management of the administrative aspects of therapeutic radiopharmaceutical clinical trials. This position requires a deep understanding of theranostics, radiopharmacy, nuclear medicine and clinical trial protocols. The Theranostics Project Administrator will assist with implementation, quality control, and compliance of clinical research conduct of Theranostic oncology clinical trials and ensure that all clinical trial activities adhere to regulatory standards and are executed efficiently, while also managing cross-functional teams and maintaining strong communication with stakeholders.
Minimum Qualifications
Bachelor’s degree in a health sciences or related field with two years professional research experience in human subject research. Preferred Oncology Clinical Trials experience. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.
Must obtain Clinical Research Professional certification within 1 year of hire from either SoCRA or ACRP . Certification in clinical research (e.g., CCRP , CCRC ) is highly desirable.
Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.
IRB CITI Courses per departmental policy
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
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. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position.
Responsibilities
Responsibilities
Oversee and lead the planning, coordination, and execution of therapeutic radiopharmaceutical clinical trials under the direction of the of HCI Theranostics Program Leader and CTO Program Manager.
Monitor trial progress and ensures compliance with study protocols, GCP (Good Clinical Practice) guidelines, and regulatory requirements.
Collaborate with principal investigators, sub-investigators, nuclear medicine radiologists, HCH Infusion, CQCI (Center for Quantitative Cancer Imaging) and radiopharmacists to ensure alignment with trial objectives.
Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
Mentors and trains the Theranostics clinical research coordinators and research data coordinators across the CTO .
Contributes to developing educational materials and assist with educating the study team, the community and other research professionals regarding studies regarding Theranostics research.
Oversee the collection, management, and quality of clinical trial data to ensure accuracy, completeness and timely submission.
May assist in a clinical research coordination role where necessary with study coordination responsibilities related to research participant inquiries and overseeing study visits.
Conduct regular audits of trial processes and documentation to ensure compliance with SOPs (Standard Operating Procedures) and regulatory requirements.
Prepares for and assists Theranostic trials site staff in coordination of site visits made by sponsors or federal agencies during the course of and at the close of the study.
Act as the primary point of contact for internal and external stakeholders, including sponsors, CROs (Contract Research Organizations), and regulatory agencies.
Has working knowledge to prepare, submit and maintain IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence.
Provides administrative support to the Theranostics Clinical Trials Feasibility and Logistics Committee. Schedules and attends monthly meetings, maintains data specific to Theranostics trials including but not limited to active and pending trials status, enrollments, new trial presentations, meeting action items and preparation of reports to CTO leadership.
Provides administrative support to the Theranostics Central Lab Sub-committee Meetings with University of Utah Radiation Safety Committee members, CTO Specimen Processing, CTO Regulatory, HCH Infusion and CQCI on study lab and tissue collections related to staff safety.
Understands the complex Theranostics clinical trial sample processing requirements per study instructions under the guidance of the Theranostics Central Lab Sub-committee.
Attend the FAR (Feasibility Administrative Review) Committee to review and report on program management of the new Theranostics study.
Must be able to work independently and have strong communication and human relations skills.
This job description is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Work Environment and Level of Frequency typically required
Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required
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 two years 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.
This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers, and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.
Preferences
Prior clinical research experience
Type Benefited Staff
Special Instructions Summary
Additional Information
The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.
This position may require the successful completion of a criminal background check and/or drug screen.
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. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.
To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action ( OEO /AA). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu
https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.