Job Details

PS Clinical Research Coord

Position Number: 6195455
Location: Salt Lake City, UT
Position Type: Medicine - Other Medicine

PS Clinical Research Coord

Job Summary

Job Summary:
The Division of Pediatric Endocrinology at the University of Utah School of Medicine has an immediate opening for a Clinical Research Coordinator. The Clinical Research Coordinator will be responsible for leading team efforts in the successful coordination and completion of several new clinical trial projects aimed at improving the lives of children with endocrine disorders. Current, upcoming and previous study examples include research on diabetes, growth disorders, and rare endocrine conditions. Under the guidance of the Clinical Research Manager and Principal Investigators, this position will coordinate the implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies. Examples of responsibilities include interfacing with patients and parents/families, obtaining informed consents, performing and/or supervising data collection, and entering study data in electronic databases.

Mutual respect and appreciation are highly valued within the University of Utah.

The University of Utah offers a comprehensive benefits package including:

Excellent health care coverage at affordable rates
14.2% retirement contributions that vest immediately
Generous paid leave time
11 paid Holidays per year
50% tuition reduction for employee, spouse, and dependent children
Flex spending accounts
Free transit on most UTA services
Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel
Professional development opportunities

Additional benefits information is available at https://benefits.utah.edu/

Responsibilities
Essential Functions

Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
Monitors study expenses and billing for allied services; makes corrections to billing as needed.
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, performing study visit procedures (such as phlebotomy), overseeing study visits and acting as a liaison between participants and study-related parties.
Recognizes, tracks and reports adverse events and protocol deviations.
Prepares for and coordinates site visits made by monitors, sponsors or federal agencies during course and at the close of the study.
Represents the research program at meetings, national and international research consortia.
Assists with the preparation and submission of IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
May mentor and trains new junior or student research staff.
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.
Assures proper laboratory samples are collected and shipped, and results are reported to the proper entities.
Completes ongoing training on techniques of clinical research coordination and practices, FDA Good Clinical Practices (GCP), and clinical research standard operating procedures to ensure compliance with policy and procedure, research sponsors and Federal rules and regulations.

Minimum Qualifications
Bachelors 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
Department Preferences:

Phlebotomy and/or IV placement experience, or willingness to complete applicable training.
Prior experience in the pediatrics and/or diabetes/endocrine research areas.
Credentialing as a Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP).
Experience with human subjects research, demonstrated human relations skills, and working knowledge of Good Clinical Practices, FDA, ICH, and IRB regulations and regulatory compliance.
Must be a self-starter with exceptional organizational skills, ability to function independently, and attention to detail.
Ability to work within a team.
Excellent interpersonal and communications skills, both oral and written.
Proficiency in Microsoft Office and the ability to learn new software programs.
IRB CITI Course for Human Subjects and CITI GCP or IATA DGR training are required within 3 weeks of hire.

Applicants will be screened according to preferences.

Special Instructions

Requisition Number: PRN41535B
Full Time or Part Time? Full Time
Work Schedule Summary: Full-time position with variable hours and days based on specific trial needs. Must be highly flexible with work hours and willing to cover Saturday shifts on a fairly regular basis, as required by study protocols and visit schedules. Opportunities for a hybrid telework schedule may be available if supported by operational needs. Employees with an approved hybrid telework schedule are expected to provide their own home office space, internet connection, telephone, and have the ability to work independently.
Department: 00848 - Pediatric Administration
Location: Campus
Pay Rate Range: $39,300 to $68,349
Close Date: 6/28/2025
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/180472