Clinical Study Coordinator

University of Utah; Salt Lake City (UT); Hybrid; USD 52,000 - 68,000; Full time

Job summary

The University of Utah Huntsman Cancer Institute invites applications for a Clinical Study Coordinator in the Population Sciences Trials Office and Adapt team. The coordinator will assist PIs in conducting compliant cancer research and support study operations across the trial lifecycle.

Responsibilities include coordinating study visits, obtaining informed consent, data entry in EDC systems, and ensuring regulatory compliance with FDA/IRB guidelines.

Qualifications

• Bachelor's degree (or equiv) required or expected.
• Knowledge of Good Clinical Practices and regulatory standards.
• Experience with electronic data capture systems (EPIC/REDCAP) and IRB processes.

Responsibilities

• Coordinate clinical trials or studies with supervision and PI support.
• Assist in recruitment, consent, and data collection activities.
• Maintain study documentation and ensure regulatory compliance (FDA/IRB).
• Schedule visits, manage CRFs, and support audits and monitoring.
• Collaborate with staff to meet study objectives and timelines.

Skills

Organizational skills

Good Clinical Practice

IRB awareness

EPIC/REDCap experience

Education

Bachelor's degree in related field

Tools

EPIC

REDCap

Job description

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

Job Summary

The Population Sciences Research Infrastructure, Systems, and Management has an immediate opening for a Clinical Study Coordinator in the Population Sciences Trials Office and Adapt team at the Huntsman Cancer Institute. The coordinator will assist the Principal Investigator(s) in completion of sound, ethical, and compliant research aimed at improving the lives of people who have cancer or prevent cancer altogether. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies. This work may include supporting investigator-initiated studies and sponsored projects.

The Population Sciences Trials Office ( PSTO )/Adapt supports Investigators conducting observational and behavioral intervention studies aimed at preventing cancer in different populations and/or at improving outcomes and the quality of life among those diagnosed with cancer. This coordinator will work with a collaborative team of study support staff under the direction of the PSTO /Adapt research manager to support the Principal Investigator’s research objectives.

Depending on study needs, employees may have a hybrid work schedule after completing a probationary period, working both remotely as well as on-site. Employees may need to provide their own home office space, internet connection, telephone, and have the ability to work independently.

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. Partnerships with individuals, communities, and many other entities are crucial to our work. Huntsman Cancer Institute values improving access to cancer prevention, care, and survivorship services and is committed to providing high-quality support to the patients and communities we serve. We strive to foster a respectful, collaborative, and welcoming work environment for employees, patients, and partners.

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 about the great benefits of working for University of Utah: benefits.utah.edu

• An environment focused on collaboration, wellness, accountability, excellence and transparency
• Opportunity to harness a growth mindset and contribute to research that could benefit generations to come

The department may choose to hire at any of the below job levels and associated pay rates based on their business need and budget.

Responsibilities

This position will coordinate the fundamental technical and administrative details involved in clinical trials or research studies with some supervision, including but not limited to, the following:

• Providing back-up team coverage when needed.

Essential Functions

Responsible for study maintenance

Uphold institutional and departmental expectations and policies.

Study Operations

• Support the clinical Principal Investigator (PI) in daily trial activities.
• Assist Principal Investigators in achieving study objectives by implementing and completing study protocols and procedures.
• Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety. Assesses protocol for clarity and subject safety, reviews study inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.
• Participate in participant recruitment and consent processes, helping ensure accurate documentation management throughout the study.
• Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines.
• Determines length of visits and coordinates related facility and equipment availability.
• Coordinate study visits and help ensure the availability of necessary resources for successful study outcomes.
• Completes, audits, corrects CRFs, relays CRFs to sponsor.
• Complete and audit case report forms (CRFs) for accuracy, with guidance as needed.
• Maintains documents as required by FDA guidelines.
• May maintain contact with IRB and prepare and submit IRB documents.
• May ensure proper collection, processing and shipment of specimens.
• Manage communication and problem-solving related to study execution.
• Collects, compiles and enters data into study electronic data capture system.
• Schedules appointments, visits and meetings.
• Performs quality control through audits in order to resolve discrepancies and overlaps with data.
• Assist CRC and Sr CRC with preparing for audit and monitoring visits.

Finance

• None

Regulatory

• Assist in protocol modifications.
• Ensure training requirements are met for study personnel.
• Cooperate with compliance efforts related to sponsored program administration and human research participant protection.
• Reports and tracks adverse events (AE) and reports them to the study lead(s). Reports serious AEs to study leads to inform IRB and sponsor.
• Documents all protocol deviations, reconciles test article accountability at study close out and may assist in preparing summary report for sponsor.

Supervision

• Report to the program manager and senior clinical research coordinator (if applicable) for study-related items and the clinical research manager.

Onboarding

None

• The study coordinator may be responsible for other duties as assigned.
• 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.

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 Study Coordinator, I:

Requires a bachelor’s (or equivalency) up to 2 years of directly related work experience or a master’s (or equivalency) degree.

Preferences

• Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills
• Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations.
• Experience with the IRB and ERICA
• Experience with EPIC and electronic data capture systems, like REDCap
• Experience in a health-care setting or health care certification.
• Ability to work as part of a team and also work independently.
• Bachelor’s degree in a related field, or equivalency. IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire and demonstrated human relations and effective communication skills are also preferred.

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 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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