Clinical Project Managers

Details This; Campus (IL); On-site; USD 85,000 - 115,000; Full time

Job summary

Huntsman Cancer Institute seeks a Clinical Project Manager to coordinate all aspects of clinical studies from initiation through delivery. This patient-focused role requires adherence to CDC vaccination standards and hospital policy.

You will lead cross-functional teams, ensure timelines and budgets are met, and develop essential study documentation while maintaining regulatory compliance. The institution emphasizes cancer prevention and community impact.

Qualifications

• 1 year of higher education can be substituted for 1 year of directly related work experience.
• Bachelor’s degree + 6 years or Master’s +4 years of directly related work experience.
• Oncology experience preferred.

Responsibilities

• Supports Principal Investigators and study management staff with patient screening/enrollment and data submission.
• Ensures quality source documents and data for sponsors with protocol compliance.
• Monitor eligibility, protocol requirements, and data submission; resolve delinquency and queries.
• Provide direction and oversight; mentor junior staff and plan coverage.
• Develop SOPs and Work Practice Documents; oversee start-up activities and CDA/Feasibility processes.

Skills

Clinical trials

Project management

Regulatory knowledge

Leadership

Education

Bachelor's degree or equiv

Tools

Clinical Trial Management Software

Job description

Priority Review Date (Note - Posting may close at any time)

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

Responsibilities

Applicants 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.

Type

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 [phone] 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 [phone] or [phone] or University Human Resource Management at [phone] 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 possess a strong commitment to improving access to higher education.
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.
Consistent with state and federal law, the University of Utah 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 Title IX ( OEO ). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at