Clinical Trial Activation Coordinator

Utah; Salt Lake City (UT); On-site; USD 39,300 - 61,384; Full time

Job summary

Huntsman Cancer Institute is seeking a Regulatory Coordinator (Clinical Trial Activation Coordinator) to support activation activities within the CTO. The role includes coordinating workflows, handling NDAs, feasibility, and site visits, and serving as a liaison with sponsors and internal teams to ensure timely study activation.

The position emphasizes collaboration with research managers, investigators, and sponsors while maintaining regulatory compliance and data quality.

Qualifications

• Bachelor’s degree in a research or related area plus two years of clinical trials/research experience or equivalency.
• One year of regulatory experience is preferred.
• Strong communication and human relations skills are required.

Responsibilities

• Coordinate activation workflows to meet timelines.
• Execute confidentiality agreements for clinical trial opportunities.
• Maintain activation resources and start‑up materials.
• Complete feasibility questionnaires for trials.
• Liaise with sponsors, vendors, and internal teams; provide regular status reports.

Skills

Communication skills

Human relations

Project coordination

Education

Bachelor’s degree in a research or related area

Tools

Microsoft Office

Job description

PS Regulatory Coordinator (Clinical Trial Activation Coordinator)

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. Responsibilities include evaluating new clinical trial opportunities with faculty principal investigators and clinical trial research managers, facilitating and building strategic relationships with research partners, facilitating confidentiality agreements, completing feasibility questionnaires, conducting pre-study site visits, and tracking opportunities and outcomes. The coordinator will serve as liaison with sponsors and vendors, assist with deliverables to multidisciplinary 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. Executes confidentiality agreements for all clinical trial opportunities.
3. Maintains trial activation resources, brochures, and start‑up materials for the activation process.
4. Completes feasibility questionnaires for clinical trials presented to the Clinical Trials Office.
5. Liaises with internal or external clients, sponsors, or partners for assigned studies, projects, or programs. Acts as lead contact for all project matters, manages contractual and organizational client expectations, nurtures client relationships, and provides sponsors with regular reports on project status and metrics.
6. Manages project deliverables and tracks progress by keeping close metrics, including but not limited to time and quality; follows up on action items and works with the Project Administrator and Manager to identify, resolve, or escalate issues.
7. Represents the Clinical Trials Office in HCI Clinical Trial Research Group meetings.
8. Completes intake Clinical Trial Research Group new study review and prioritization forms.
9. Submits trial packages to the Feasibility Administrative Review committee and follows up on action items to achieve approval.
10. Works with the Office of Sponsored Projects and CTO Finance Pre‑Award team to ensure appropriate and timely execution of CDAs, CTAs, and study budgets; assists in scheduling calls and supporting negotiations.
11. Organizes and actively participates in sponsor site visits in cooperation with research managers and administrators.
12. Serves as an internal liaison to bridge trials from activation to start‑up.
13. Acts as liaison between study sponsors, HCI investigators, and the Clinical Trials Office by evaluating problems and providing solutions.
14. Operates 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. Promotes a positive work environment through open and effective communication.
16. Acts as first point of contact for potential outside CROs and sponsors, serving as the face of the HCI CTO.
17. Establishes and fosters strong relationships and interactions with HCI investigators, study sponsors, and Clinical Trials Office personnel.
18. Ensures high quality of data and metrics for study sponsors and research teams.
19. Assists in process and efficiency improvements in the trial activation area.
20. Must be able to work independently and has 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

Nearly continuously: Office environment.

Physical Requirements

Nearly continuously: Sitting, hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking.

Seldom: Bending, reaching overhead.

Minimum Qualifications

Bachelor’s degree in a research or related area plus two years of 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. All patient‑sensitive employees must 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 of 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 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, 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.

Location & Compensation

Location: Campus, Salt Lake City, UT. Pay Range: $39,300 to $61,384.25 per year.

Equal Employment Opportunity

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, 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.

Online reports may be submitted at https://oeo.utah.edu. Additional safety and reporting information can be found at https://publicsafety.utah.edu/safetyreport/.

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.