Clinical Research Coordinator

Utah; Salt Lake City (UT); On-site; USD 58,000 - 82,000; Full time

Job summary

The University of Utah’s Population Sciences Trials Office (PSTO) / Adapt team invites applications for a Clinical Research Coordinator to support Hematologic Malignancies (Heme) Adapt and related projects. The role involves collaboration with Principal Investigators to ensure ethical, compliant research and manage study operations.

Hybrid work may be available after a probationary period, with potential remote work and on-site requirements.

Qualifications

• Bachelor’s degree in a health sciences or related field; equivalency allowed with two years related work experience.
• Two years professional research experience and completion of clinical certification within one year.

Responsibilities

• Support study operations and regulatory requirements across investigator-initiated and sponsored projects.
• Coordinate participant logistics, informed consent, scheduling, and data entry.
• Ensure protocol adherence, quality control, and preparation of sponsor reports.

Skills

Study coordination

Regulatory compliance

IRB/FDA/HIPAA knowledge

Education

Bachelor's degree in health sciences

Tools

EPIC

REDCap

Job description

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.

Responsibilities

• 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.

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.
• Oversees, assesses and ensures 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.
• Prepares for and coordinates site visits made by sponsors or federal agencies during conduct 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.
• Prepares 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.
• Recognize, track and report adverse events and protocol deviations.
• Document and report all protocol deviations to program manager and/or senior clinical research coordinator, reconcile test article accountability at study close‑out and prepare 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.

Minimum Qualifications

Bachelor’s degree in a health sciences or related field or equivalency (one year of education can be substituted for two years of related work experience) with two years professional research experience and completion of University RATS Clinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.

Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.

Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.

Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification.

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.

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

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.

Type: Benefited Staff

Additional Information: This position may require the successful completion of a criminal background check and/or drug screen.

Equal Opportunity Employer Statement

Consistent with state and federal law, the University of Utah does not discriminate upon basis of 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.