PS Study Coordinator

University of Utah; Salt Lake City (UT); On-site; USD 31,000 - 56,000; Full time

Job summary

An established industry player in healthcare education is seeking a dedicated Study Coordinator to join their Department of Pediatrics. This pivotal role involves coordinating clinical and research studies, ensuring the integrity of protocols, and maintaining compliance with regulatory requirements. The position offers ample opportunities for professional growth and development, along with a comprehensive benefits package. Ideal candidates will possess strong problem-solving abilities, effective communication skills, and a Bachelor’s degree in a related field. If you’re passionate about advancing medical research and making a difference, this role is perfect for you.

Benefits

Employee Discounts on Products and Services

Qualifications

• Bachelor's degree required; equivalent work experience may substitute.
• IRB CITI Course certification must be obtained within six months.

Responsibilities

• Coordinate technical and administrative details of clinical studies.
• Ensure subject safety and document all protocol deviations.
• Assist with negotiating contract budgets and maintain IRB documents.

Skills

Effective Communication Skills

Problem Solving

Attention to Detail

Interpersonal Skills

Education

Bachelor's Degree in a Related Field

Tools

Microsoft Office

Job description

Monday through Friday, 8:00 a.m. to 4:30 p.m.

VP Area

VP Area U of U Health - Academics

Department

Department 00848 - Pediatric Administration

Location

Location Campus, Salt Lake City, UT

Type of Recruitment

External Posting

Pay Rate Range

$31,600-$55,621

Close Date

04/10/2025

Job Summary

The Department of Pediatrics, Division of Medical Genetics at the University of Utah School of Medicine has an immediate opening for a Study Coordinator. This role coordinates technical and administrative details involved in clinical or research studies, assisting the Principal Investigator in achieving study integrity and objectives through successful implementation and completion of protocols and procedures.

Positions are designed to provide growth and professional development opportunities, including promotions within a defined career ladder.

The University of Utah offers a comprehensive benefits package including:

• Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel.

Responsibilities:

• Assess protocol for clarity and subject safety, reviewing inclusion/exclusion criteria; clarifying concerns with Principal Investigator and sponsor.
• Attend and participate in Investigator and staff meetings, advising the team regarding specific study assignments and timelines.
• Explain and obtain informed consent, medical history, and demographics; document in source files and maintain historical data, status reports, progress notes, and subject logs to ensure subject safety.
• Determine length of visits and coordinate related facility and equipment availability.
• Report and track adverse events (AE), reporting serious AEs to IRB and sponsor.
• Document all protocol deviations, reconcile test article accountability at study close out, and prepare summary report for sponsor.
• Complete, audit, correct CRFs, and relay CRFs to sponsor.
• Assist with negotiating contract budgets and payment terms.
• Maintain documents as required by FDA guidelines.
• Maintain contact with IRB and prepare and submit IRB documents.
• Ensure proper collection, processing, and shipment of specimens.
• Perform functions required of the Clinical Research Assistant as necessary.

Problem Solving:

Incumbents are responsible for coordinating the daily operations of their assigned research team, ensuring the orderly and safe flow of the research project and maintaining adequate resources for the PI to accomplish their research objectives.

Minimum Qualifications:

Bachelor’s degree in a related field, or equivalency (one year of education can be substituted for two years of related work experience) required. 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 required.

Preferences:

Previous clinical research experience is preferred. Knowledge of Good Clinical Practices, FDA, HIPAA, and IRB regulations; an understanding of research procedures; attention to detail; and the ability to function independently. Excellent interpersonal and communication skills, both oral and written. Proficiency in Microsoft Office and ability to learn new software programs.

Additional Information:

The University is a participating employer with Utah Retirement Systems. 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