Job Information
University of Utah Multi-Site Project Administrator in Salt Lake City, Utah
Details
Open Date 05/08/2024
Requisition Number PRN38494B
Job Title PS Project Administrator
Working Title Multi-Site 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 01345 - HCI Clinical Resrch Compliance
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 47600 to 75000
Close Date
Open Until Filled Yes
Job Summary
This position will provide project management, regulatory and data management oversight for multi-site trials coordinated by the Research Compliance Office from trial start-up through trial closeout. The incumbent will act as a liaison between the clinical sites, the Research Compliance Office and sponsors/agencies to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory guidelines. As a member in the Research Compliance Office department, the candidate may also be responsible for quality assurance oversight of clinical trials and reporting study progress to the Data Safety Monitoring Committee ( DSMC ).
HuntsmanCancer 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. Partnerships with individuals, communities, and many other entities are crucial to our work. Huntsman Cancer Institute values cancer-related health equity, and inclusion as integral to our guiding principle to serve our patients and their communities, and our commitment to foster a culture of belonging for all within our organization.
In your cover letter or during your interview process, we invite you to share how your personal and 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.
Learn morehere
Responsibilities
Essential Functions:
Develop and maintain site feasibility packets, multi-site study procedural manuals, and other multi-site process documents.
Prepare clinical sites for study start-up by reviewing and tracking regulatory documents, ordering start-up supplies and conducting site initiation visits.
Ensures updated copies of regulatory essential documents are maintained in trial master files and manages the study progress in relation to the project timelines.
Assure that the clinical sites are enrolling subjects, collecting data, and conducting the trial in compliance with approved protocol version, GCP and ICH guidelines.
Prepares and facilitates advanced regulatory submissions, including IND and/or IDE applications and reports to the FDA . This includes Expanded Access Single Patient IND requests.
Analyzes and mitigates complex, non-routine regulatory issues and workflow problems.
Acts as a liaison between the University parties (PI, regulatory team, study team, etc.) and study sponsors and/or regulatory agencies on all issues pertaining to regulatory compliance. Serves as a resource to the clinical research staff on advanced regulatory issues and concepts.
Drafts, formats, and edits informed consent forms (ICFs).
Works directly with Principal Investigators (PIs) and study team members to ensure stipulations from approving bodies are addressed appropriately and in a timely manner.
Communicate with external sites determinations made on behalf of the DSMC .
Oversees the maintenance and organization of project documentation and records.
Act as a liaison between the clinical site(s), HCI University parties (PI, regulatory team, study team, etc.) study sponsors and/or regulatory agencies and the research compliance office to resolve any issues that may arise throughout the course of the study.
Other responsibilities may include but are not limited to; updating and revision of SOPs, training and orientation of study staff, organization of coordinator/investigator meetings.
Provides guidance and training to research faculty and staff pertaining to complex and highly specialized rules and regulations including complex protocol, multi-site trials and IND / IDE regulations.
Assist in the development and submission of investigator initiated clinical studies to appropriate regulatory review committees.
Ensures participating sites provide the necessary regulatory documentation to participate in a multi-site investigator initiated trial.
Assists in the development of policies, procedures and process improvements for departmental implementation and guidance for external associates.
Perform other duties as assigned by management.
Problem Solving
This position utilizes federal, institutional guidelines and requirements to inform and complete submission of regulatory documents. This position also negotiates with University research committees and sponsors to ensure full compliance and communication.
The incumbent decides how to best accomplish the daily requirements of various regulatory objectives, prioritizes workload and establishes systems needed to achieve specific goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved following FDA , Good Clinical Practice, IRB , NIH , and/or other regulatory agency guidelines. Incumbent will be responsible for resolving and/or making appropriate recommendations for correction or full resolution to the Director and other members of the management team.
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
Preferred Qualifications
Experience in the management of clinical trials and the investigator initiated clinical development process.
Oncology clinical trial experience highly preferred.
Working knowledge of Food and Drug Administration ( FDA ) requirements, Office of Human Research Protection ( OHRP ), International Conference of Humanization ( ICH ) Good Clinical Practice ( GCP ), as well as state and federal guidelines.
Knowledge of clinical development process sufficient to effectively direct and manage multiple projects and timelines.
Strong attention to detail, establishing priorities, and adhering to deadlines.
Able to show initiative and work independently, take initiative and complete tasks to meet deadlines.
Excellent interpersonal communication (including oral and written) and leadership skills also required.
Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project, and other project management tools.
SOCRA or ACRP certification.
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.