Clinical Research Coordinator

Job Summary

The Population Sciences Research Infrastructure, Systems, and Management team has an immediate opening for a Clinical Research Coordinator within the Population Sciences Trials Office and Adapt team at Huntsman Cancer Institute. This role partners with Principal Investigators to support high-quality, ethical, and compliant research aimed at improving cancer outcomes and prevention, while overseeing study operations and regulatory requirements across investigator-initiated and sponsored projects. The position will specifically support the Hematologic Malignancies (Heme) Adapt program, contributing to research within a specialized disease center focused on hematologic cancers.

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 can 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.

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

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 technical and administrative details involved in a clinical or research study, including but not limited to, the following:

• Providing back-up team coverage when needed.
• Support various projects related to this specific cancer type,
• Attend meetings and consult with the Hematology (Heme) Disease Center, and other research teams.

Responsible for study maintenance.

Uphold institutional and departmental expectations and policies.

Anticipate potential challenges and proactively seek solutions to avoid or mitigate existing and future problems.

Study Operations

• Assists in study-specific training for junior staff members
• Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; assist in preparation of reports for organizations and agencies.
• Oversee, assess and ensure participant safety and strict protocol implementation/adherence.
• Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance.
• Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties.
• Represents the research program at meetings, national and international research consortia.
• Prepare for and coordinate site visits made by sponsors or federal agencies during course and at the close of the study.
• Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
• Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
• Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
• Assists the Principal Investigator in the development of study protocols.
• Primary contact with PM in cc for audits and monitor visits.
• Schedules and properly documents appointments, visits and meetings.
• Prepare for monitor and audit visits.
• Oversees two or more research studies in both an administrative and operational capacity.
• Coordinates technical and administrative details involved in research or clinical studies.
• Exposure to study the development of full study life-cycle from study start-up to closure.
• Take initiative in identifying and addressing knowledge gaps through self-directed learning, attending workshops, researching existing resources, and participating in relevant training programs.
• Responsible for ensuring project success in study maintenance phase.
• Proficient in all study coordinator duties.

Finance

• Oncore calendar review
• Biller and Study Team EPIC review

Regulatory

• Assist in protocol modifications.
• Cooperate with compliance efforts related to sponsored program administration and human research participant protection.
• Recognizes, tracks and reports adverse events and protocol deviations.
• Documents and reports all protocol deviations to program manager and/or senior clinical research coordinator, reconciles test article accountability at study close out and prepares 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

• Assist Sr. CRC in providing mentorship and onboarding to newly onboarded study coordinators

The clinical research coordinator may be responsible for other duties as assigned.

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 that may be required:

Nearly Continuously: Office environment.

Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids).

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Hearing, listening, talking.

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

Seldom: Bending, reaching overhead.

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 Research Coordinator (Non-R.N.), II: Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience.

Preferences

• 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.
• Comfortable engaging with study participants in person, by phone, and virtually.

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 (801) 581-7447 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 (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 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.

Online reports may be submitted at https://oeo.utah.edu

https://publicsafety.utah.edu/safetyreport/ This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.

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.