- 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.
- 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.
- Do you have a related Bachelor's degree or equivalency? (2 years related work experience may be substituted for 1 year of education)
- Yes
- No
- Do you have 4 or more years of progressively more responsible related experience?
- Yes
- No
- Do you have a Master's degree?
- Yes
- No
- Do you have any current relatives working in HCI?
- Resume
- Cover Letter
- Addendum to the University of Utah - Veteran Only - Call after submission
- Appropriate discharge document (such as a DD-21- Member Copy 4) - Veteran Only - Call
-
Project Administrator
1 week ago
University of Utah Salt Lake City, United StatesThe Business Development Manager is responsible for driving the profitable growth of Executive Education courses, conferences, and projects (non-degreed programs) to clients through prospecting, client management, and relationship-based methods. Your Administrator, Program Coordi ...
-
Project Administrator
1 day ago
The Sundt Companies Salt Lake City, United StatesAs a 100% employee-owned contractor, when you work at Sundt, you're not just hiring on at a company, you're joining a culture. Because everyone at Sundt is part owner, you'll join a team of people who are deeply invested in their work. From apprentices to managers, we're passiona ...
-
Project Administrator
1 day ago
University of Utah Salt Lake City, United StatesBookmark this Posting | Print Preview | Apply for this Job · Announcement · Details · Open Date 04/26/2024 Requisition Number PRN38381B Job Title Project Administrator Working Title Business Development Manager Job Grade F FLSA Code Administrative Patient Sensitive Job Code? No S ...
-
PS Project Administrator
1 week ago
University of Utah Salt Lake City, United StatesThis 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 cl Clinical Research, Administra ...
-
PS Project Administrator
2 weeks ago
University of Utah Salt Lake City, United StatesResponsible for the general organization and daily activities of the Huntsman Cancer Institute Clinical Trials Office Specimen Processing trial feasibility, start up, maintenance and compliance. This will include supervising all aspects of the Specim Administrator, Project, Clini ...
-
PS Project Administrator
1 day ago
University of Utah Salt Lake City, United StatesBookmark this Posting | Print Preview | Apply for this Job · Announcement · Details · Open Date 05/15/2024 Requisition Number PRN38545B Job Title PS Project Administrator Working Title Multisite Project Administrator Job Grade F FLSA Code Administrative Patient Sensitive Job Code ...
-
PS Project Administrator
2 weeks ago
University of Utah Salt Lake City, United StatesBookmark this Posting | Print Preview | Apply for this Job · Announcement · Details · Open Date 04/17/2024 Requisition Number PRN38286B Job Title PS Project Administrator Working Title PS Project Administrator Job Grade F FLSA Code Administrative Patient Sensitive Job Code? Yes S ...
-
The Church of Jesus Christ of Latter-day Saints Salt Lake City, United StatesProperty Reserve is the commercial real estate investment group for the reserve fund of The Church of Jesus Christ of Latter-day Saints. Building on more than 50 years of experience, we have established a reputation for excellence in the United States and have expanded into inter ...
-
Project Administrator
1 week ago
Tundra Technical Solutions West Jordan, United StatesCompany Description: · Our Client is a global leader in public safety and enterprise security. Our solutions in land mobile radio communications, video security & access control and command center software, bolstered by managed & support services, create an integrated technology ...
-
Project Developer
1 week ago
Phoenix Industries Lake City, United StatesResponsibilities · Responsible for tomorrow: analyzing and evaluating locations for charging infrastructure projects; independently planning, executing, and successfully completing projects · Developing concepts for charging hubs and charging parks · Creating business cases and i ...
-
Strategic Purchaser
2 weeks ago
BlueWave Solutions North Lake, United StatesNorth Lake in Flensburg is looking for a full-time permanent employee to join our team. Are you ready to shape the future with us? Come and get to know us and be a part of it. · We are seeking a dedicated individual to strengthen our purchasing team. In this role, you will be res ...
-
IT specialist
1 week ago
Spectrum Ventures Lake City, United StatesThe State Media Center Baden-Württemberg (LMZ), with its two locations in Stuttgart and Karlsruhe, is a legal institution of public law. It supports schools and institutions of youth and adult education in media education issues, provides advice and offers training on contemporar ...
-
pedagogical specialist/educational professional
2 weeks ago
Phoenix Industries Lake City, United StatesThe city of Dornstetten (district of Freudenstadt, approx. inhabitants) is seeking a (social) pedagogical specialist (m/f/d) to lead the Youth Department/Youth House Dornstetten as soon as possible on a part-time basis of 50.00% % (approximately hours/week). · Your tasks: · Coord ...
-
Training as an industrial clerk part-time
1 week ago
Eclipse Enterprises Mountain Lake, United States Part timeWe are an internationally successful trading company of the Schwarz Group. Join Kaufland and find the perfect start to your professional career with us at Mountain Lake. · What to expect from us · Learn about commercial, administrative, and organizational processes and tasks in a ...
-
IT Support Specialist
1 week ago
Nexus Dynamics Lake City, United StatesAt FERCHAU, we are looking for experts like you to take technologies to the next level, tackle challenges, and work on the innovations of tomorrow in Lake City. We realize exciting projects for renowned providers and developers of IT solutions and integrate IT systems into our cl ...
-
Rheumatologist Specializing in Vasculitis
1 week ago
Adelphi Medical Staffing Salt Lake City, United StatesSeeking a Rheumatologist Specializing in Vasculitis to provide care to patients at a facility in Salt Lake City, Utah. The ideal candidate will have the rank of an associate or full Professor with demonstrated expertise in diagnosing and managing vasculitic disorders, and providi ...
-
Rheumatologist
1 week ago
Adelphi Medical Staffing Salt Lake City, United StatesSeeking a Rheumatologist to provide care to patients at a facility in Salt Lake City, Utah. The ideal candidate will have a strong background in diagnosing and treating a wide range of rheumatologic conditions, providing exceptional patient care, and will also have a passion for ...
-
Rheumatologist Specializing in Vasculitis
1 week ago
Adelphi Medical Staffing Salt Lake City, United StatesAdelphi is seeking a Rheumatologist Specializing in Vasculitis to provide care to patients at a facility in Salt Lake City, Utah. The ideal candidate will have the rank of an associate or full Professor with demonstrated expertise in diagnosing and managing vasculitic disorders, ...
-
Project Administrator
1 day ago
Big-D Companies Morgan, United StatesBig-D is looking for a dynamic Project Administrator. This is a great opportunity to start a career with a company that is on a mission to be the most sought-after company in the business. We seek and employee exceptional, hard-working, lifetime learners; we give them the tools t ...
-
Project Administrator
2 weeks ago
Big-D Companies Park City, United StatesBig-D is looking for a dynamic Project Administrator. This is a great opportunity to start a career with a company that is on a mission to be the most sought-after company in the business. We seek and employee exceptional, hard-working, lifetime learners; we give them the tools t ...
PS Project Administrator - Salt Lake City, United States - University of Utah
Description
Bookmark this Posting | Print Preview | Apply for this JobAnnouncement
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 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).
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.
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 more hereResponsibilities
Essential Functions:
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 requiredNearly 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.
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
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 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 or or University Human Resource Management at 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.
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).
Online reports may be submitted at
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.
Posting Specific QuestionsRequired fields are indicated with an asterisk (*).
Applicant Documents
Required Documents