PS Regulatory Coordinator

Details This; Campus (IL); On-site; USD 60,000 - 95,000; Full time

Job summary

Huntsman Cancer Institute's Clinical Trials Office is seeking a coordinator to assist activation activities for oncology trials. You will support the Activation Project Administrator, evaluate new trial opportunities, and help build strategic relationships with research partners.

The role includes feasibility, site visits, CDAs/CTAs, budgets, and performance metrics to drive efficient trial activation. The position emphasizes cross‑functional collaboration with sponsors, investigators, and

Qualifications

• Bachelor’s degree in a research or related area
• Two years clinical trials/research experience or equivalency
• Demonstrated human relations and effective communication skills
• One year of regulatory experience (preferred)

Responsibilities

• Coordinate activation workflows to ensure timelines are met
• Execute confidentiality agreements for clinical trial opportunities
• Maintain activation resources, brochures and start-up materials
• Complete feasibility questionnaires for trials
• Liaise with sponsors, partners and internal teams; provide regular project reports and manage client expectations
• Manage project deliverables with progress tracking and issue escalation
• Represent CTO in Clinical Trial Research Group meetings
• Submit trial packages for feasibility review and follow-up actions
• Coordinate with Office of Sponsored Projects and CTO Finance Pre-Award on CDAs, CTAs and study budgets
• Organize sponsor site visits and act as internal liaison to bridge activation to start-up
• Evaluate problems and propose solutions with sponsors and investigators
• Adhere to regulatory guidelines and immunization requirements
• Promote positive work environment and effective communication
• Serve as face of CTO to potential CROs and sponsors
• Foster strong relationships with investigators, sponsors and CTO staff
• Ensure high data quality and metrics for sponsors and teams
• Support process and efficiency improvements in trial activation
• Work independently with strong communication and interpersonal skills

Job description

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

Job Summary

The Huntsman Cancer Institute Clinical Trials Office ( CTO ) is hiring a coordinator to assist the Activation Project Administrator in various activation activities for oncology clinical trials conducted at Huntsman Cancer Institute. Responsible for assisting in evaluating new clinical trial opportunities for HCI with faculty principal investigators and clinical trial research managers and administrators. This will include assisting in facilitating and building strategic relationships with research partners; facilitation, tracking and execution of confidentiality agreements, completing feasibility questionnaires, conducting pre-study site visits, and tracking of the opportunities and outcomes. Serve as liaison with sponsors and vendors; assist with deliverables to clinical trial research multi-disciplinary teams; oversee project agreements; and nurture internal & external partnerships.

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

• 1. Coordinates activation workflows to ensure appropriate timelines are met.
• 2. Execution of confidentiality agreement for all clinical trial opportunities
• 3. Assists in maintaining trial activation resources, brochures and start-up materials for activation process
• 4. Completes feasibility questionnaires for clinical trials presented to the Clinical Trials Office
• 5. Liaison with internal or external clients, sponsors, or partners for assigned studies, projects, or programs. Lead contact for all project matters; understand and manage contractual and organizational client expectations; nurture client relationship and needs. Provide to the sponsor regular reports on project status, certain metrics, and issues.
• 6. Manage project deliverables. Track progress by keeping close metrics, including but not limited to time and quality. Be accountable for follow-up on action items. Work with the Project Administrator and Manager in identifying, resolving, or escalating issues.
• 7. Represent the Clinical Trials Office in HCI Clinical Trial Research Group meetings
• 8. Complete intake Clinical Trial Research Group new study review and prioritization forms.
• 9. Submit trial packages to the Feasibility Administrative Review committee and follow-up on action items to achieve approval.
• 10. Liaise with the Office of Sponsored Projects and CTO Finance Pre-Award team to ensure appropriate and timely execution of CDAs, CTAs and study budgets. Assist in scheduling calls and supporting negotiations in these areas.
• 11. In cooperation with research managers and administrators, organize and actively participate in sponsor site visits.
• 12. Serve as an internal liaison to bridge trials from activation to start-up.
• 13. Act as a liaison between study sponsors, HCI investigators and the Clinical Trials Office by evaluating problems and providing solutions.
• 14. Understand and act within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the conduct of clinical research.
• 15. Promote a positive work environment that is maintained through open and effective communication
• 16. Serve as first point of contact for potential outside CROs and sponsors. Be the face of the HCI CTO .
• 17. Establish and foster strong relationships and interactions with HCI investigators, study sponsors and the Clinical trials office personnel.
• 18. Ensure high quality of data and metrics to study sponsors and research teams.
• 19. Assist in process and efficiency improvements in the trial activation area.
• 20. 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.

Minimum Qualifications

Bachelor’s degree in a research or related area plus two years clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience) required; demonstrated human relations and effective communication skills also required.

One year of regulatory experience, an understanding of medical terminology and technical writing experience 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

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 preferred.

• Knowledge of FDA regulations relevant to drugs, devices, biologics
• Previous working knowledge and experience with the pharmaceutical sponsors and contract research organizations
• Attention to detail with excellent analytical and problem-solving skills
• Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology in oncology
• Ability to manage multiple tasks and set priorities and meet deadlines
• Work within a team approach and be motivated to work consistently in a fast-paced, "customer-focused" environment
• Excellent organizational and communication skills
• Skilled in Microsoft Office

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Required Documents

• Resume

Optional Documents

• Cover Letter

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 the: University of Utah Non-Discrimination page.

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As per University of Utah policy 5-108: Transfer of Benefits Eligible Staff Members , a new hire to the University of Utah who is still serving a 12 month probationary period will not be hired into another University of Utah job (a transfer) until the successful completion of the probationary period.

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