Clinical Research Coordinator

Clinical Research Coordinator

Job Summary

Coordinates complex clinical trial activities and plays a critical
role in the conduct of multiple research studies.

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

Oversee, assess and ensure participant safety and strict protocol
implementation/adherence; oversee compliance with GCP guidelines,
federal regulations, institutional policies and procedures, and
internal SOPs.

Develop study budgets; monitor and billing; negotiate payment
schedule and fees with sponsor.

Evaluate processes to identify obstacles to successful recruitment
and retention of study participants. Recommend and implement
innovative approaches to maximize enrollment and optimize subject
retention.

Analyze study monitoring and operational reports to monitor
production and data collection events; evaluate progress towards
meeting required timelines and data collection tasks.

Implement procedures to prevent future events, including staff
education and retraining

Prepare for and coordinate site visits made by sponsors or federal
agencies during course and at the close of the study.

Represent the research program at meetings, national and
international research consortia.

Prepare, submit and maintain IRB, FDA, NCI, NIH, NSF and/or other
regulatory documents and research correspondence

Assist in the selection and hiring process for study staff;
supervise, mentor and train new or junior research staff; provide
direction and oversee preparation of study staff for monitoring
visits; manage staff schedules ensuring shift/studies are covered;
approve requests for time off/approve KRONOS.

Contributes to developing educational materials and educates the
community and other research professionals regarding studies and
related research issues.

Develop training and staff certification materials, procedures and
requirements. Assist the PI in development of materials and tools
necessary to appropriately train individuals involved in the
conduct of the study. Oversee and train team members across the
entire spectrum of research studies to include, but not limited to:
protocol requirements, schedule of visits, recruitment plan,
execution of research plan, collecting adverse event information,
maintaining study subject documentation. Maintain records and other
documentation of training.

Helps develop applicable data management queries and oversees data
cleaning activities.

Determine subject population availability, develop recruitment,
informed consents and screening materials; help develop survey and
study data collection instruments

Evaluate new protocols for feasibility. Thoroughly review study
protocols and map process and data flow to predict areas of
vulnerability. Identify, recommend and implement solutions to
address such vulnerabilities in specific trials and across the
team's study portfolio.

Coordinate approval of new study agreements and contracts; assists
in the development of case report forms.

Develops QA/QC processes and conduct quality control activities
(field/study visits, data queries)

Determine study visit and site/clinic work flows for
studies/protocols

Works with data managers to help design, develop and test
appropriate informatics tools to meet study data, participant and
sample tracking needs

Helps to develop standard operating procedures

Compiles information for grant applications

Participates in abstract and manuscript preparation.

Problem Solving The incumbent decides how to best
accomplish the daily requirements of various study objectives,
prioritizes and delegates workload and establishes systems needed
to achieve specific study goals. Efforts of multiple departments or
disciplines must be coordinated to ensure effective follow through
and compliance of all involved. The incumbent functions
independently under minimal supervision, following FDA, Good
Clinical Practice, IRB, NIH, NCI, NSF and/or other regulatory
agency guidelines and seeking council from the Principal
Investigator as necessary.

The incumbent is expected to closely monitor use of experimental
equipment and drugs. Because some subjects referred to participate
on a research study have no other option for recovery, the
incumbent must be aware of the subjects condition, well informed in
the use of study material (devices, equipment, etc.) and
conscientious in his/her analysis of appropriate actions.

The incumbent is responsible to organize coverage when not present
to ensure protocol requirements are followed.

This job description is not designed to contain or be interpreted
as a comprehensive inventory of all duties, responsibilities and
qualifications required of employees assigned to the job.

Work Environment and Level of Frequency that may be
required: Nearly Continuously: Office environment. Seldom:
Infectious disease, oils (there is air or skin exposure to oils
or other cutting fluids).

Physical Requirements and Level of Frequency that may be
required Nearly Continuously: Hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking, standing,
sitting. Seldom: Bending, reaching overhead.

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 Research Coordinator (Non-R.N.), IV:
Requires a bachelor's (or equivalency) + 8 years or a master's (or
equivalency) + 6 years of directly related work experience.

Clinical Research Coordinator (Non-R.N.), V:
Requires a bachelor's (or equivalency) + 10 years or a master's (or
equivalency) + 8 years of directly related work experience.

Preferences

Special Instructions

Requisition Number: PRN46665B

Full Time or Part Time? Full Time

Work Schedule Summary:

Department: 00263 - Surgery Research

Location: Campus

Pay Rate Range: 39,815 - 100,474

Close Date: 02/03/2027

Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/211745

je-0cf2d1c6526e40fb80cc21955cce8d0c