Clinical Study Coordinator

Utah; Salt Lake City (UT); Híbrido; USD 49.000 - 52.000; Jornada completa

Descripción de la vacante

Huntsman Cancer Institute in Utah is seeking a Clinical Study Coordinator to support the Population Sciences Trials Office and Adapt team. You will assist the Principal Investigator with ethical, compliant research aimed at preventing cancer and improving patient outcomes.

The role involves coordinating study visits, data collection, consent processes, and regulatory tasks, with a potential hybrid work arrangement after a probation period.

Formación

• Excellent organizational and communication skills with attention to detail.
• Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations.
• Experience with IRB processes, ERICA and electronic data capture.
• Ability to work both as part of a team and independently.

Responsabilidades

• Coordinate clinical trials/observational studies under supervision.
• Assist PI in daily trial activities and protocol execution.
• Explain and obtain informed consent, document data, and ensure safety.
• Recruit participants and manage source data, logs and reports.
• Maintain regulatory documents and support IRB submissions.
• Audit CRFs, support audit visits and ensure data quality.

Conocimientos

Organizational skills

Attention to detail

Communication skills

Good Clinical Practices knowledge

FDA, HIPAA and IRB regulations

IRB experience

EPIC and REDCap experience

Teamwork and independence

Educación

Bachelor's degree in a related field or equivalency

IRB CITI Course in Protection of Human Research Subjects

Herramientas

EPIC

REDCap

Descripción del empleo

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

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 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.

Work Details

Requisition Number: PRN46517B

Full Time or Part Time? Full Time

Department: 02059 - HCI Popul Sci Trials Office

Location: Campus

Pay Rate Range: 48935 to 52000

Close Date: 01/14/2027

Open Until Filled