PS Clinical Research Coord

University of Utah; Salt Lake City (UT); On-site; USD 39,000 - 69,000; Full time

Job summary

An established industry player is seeking a Clinical Research Coordinator to lead efforts in pediatric endocrine research. This full-time role involves coordinating clinical trials, ensuring compliance with regulatory standards, and working closely with patients and families. The ideal candidate will have strong organizational and communication skills, a background in health sciences, and experience in research. This position offers a comprehensive benefits package and opportunities for professional development. If you are passionate about improving children's health through research, this is the role for you.

Benefits

Excellent health care coverage

14.2% retirement contributions

Generous paid leave time

11 paid Holidays per year

50% tuition reduction

Flex spending accounts

Free transit on UTA services

Employee discounts

Professional development opportunities

Qualifications

• 2+ years of professional research experience required.
• Knowledge of Good Clinical Practices and FDA regulations preferred.

Responsibilities

• Coordinate and oversee compliance to research protocols.
• Manage quality control and submission of study documentation.
• Recruit and interact with research participants.

Skills

Organizational Skills

Communication Skills

Attention to Detail

Phlebotomy

Research Compliance

Education

Bachelor's Degree in Health Sciences

Certified Clinical Research Coordinator (CCRC)

Certified Clinical Research Professional (CCRP)

Tools

Microsoft Office

Job description

Join to apply for the PS Clinical Research Coord role at University of Utah

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 train 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

• 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