Clinical Project Managers III
Job Summary
Clinical Project Managers
This position is patient-sensitive and must fulfill all associated
vaccination requirements, or be approved for an exemption, prior to
the first day of work. 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.
Coordinate all aspects of clinical studies from initiation through
delivery. Build and maintain relationships with sponsors,
investigators, and research staff. Prepare study-related
documentation such as protocol worksheets, procedural manuals,
adverse event reports, institutional review board documents, and
progress reports. Maintain required records and ensure compliance
with protocols, regulatory regulations, and overall clinical
objectives. Record adverse event and side effect data and confer
with investigators regarding reporting of events to oversight
agencies. Utilize project management methodologies, lead
cross-functional teams, resolve issues within the clinical study,
and ensure that all targets, timelines, budgets, and requirements
are met.
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.
Learn more about the great benefits of working for
University of Utah: benefits.utah.edu
Responsibilities
ResponsibilitiesApplicants must demonstrate the potential ability
to perform essential job functions.
- 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 (i.e., initiating CDA,
Feasibility, MDG scoring and navigation of review committees
required for activation, etc.).
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.
OTHER: Assume responsibility for additional assignments as
directed by the Program Manager
Minimum Qualifications
EQUIVALENCY STATEMENT: 1 year of higher education
can be substituted for 1 year of directly related work experience
(Example: bachelor's degree = 4 years of directly related work
experience).
Department may hire employee at one of the following job
levels: Clinical Project Manager, III:
Requires a bachelor's (or equivalency) + 6 years or a master's (or
equivalency) + 4 years of directly related work experience.
Preferences
- Three years of Oncology Clinical Research Coordinator
Experience
- Advanced knowledge and understanding of regulatory guide lines
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;
(i.e., complex trial designs, data standards, data reviews,
etc.).
- Demonstrated ability to positively influence others in a team
environment
- Four to six years of progressively more responsible leadership
experience.
- Background knowledge of hiring department's area of
specialization. SOCRA or ACRP certified.
- 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.
Special Instructions
Requisition Number: PRN45991B
Full Time or Part Time? Full Time
Work Schedule Summary:
Department: 01167 - HCI Clinical Trials Operations
Location: Campus
Pay Rate Range: 60000 to 78000
Close Date: 11/20/2026
Open Until Filled:
To apply, visit https://apptrkr.com/9783779"">https://utah.peopleadmin.com/postings/207976
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