Clinical Research Supervisor

Clinical Research Supervisor

Job Summary

Job Summary:

The Divisions of Critical Care and Clinical Pharmacology have an immediate opening for Clinical Research Supervisor in the
Department of Pediatrics at the University of Utah Spencer F.
Eccles School of Medicine. This position will supervise the clinical research operations for both divisions with responsibilities including research coordination, regulatory initiation and maintenance, compliance with study and institutional regulations, and building relationships with sponsors, investigators, and research staff in both divisions. Oversee other team members providing research coordination services on the team and will provide training and performance appraisal for them.
Develop research studies and create standards and guidelines for clinical research services and programs, monitoring adherence to protocols. Ensure clinical research strategies, policies, and procedures are maintained. Ensure adherence to Standard Operating
Procedures (SOPs), Good Clinical Practices (GCPs), and all applicable regulations. Maintain awareness of budget position on studies. Participate in the Critical Care divisions' Research
Support Committee and provide feedback on feasibility of study participation from a regulatory and research coordinator perspective. Prepare reports and keep upper-level management informed of progress and problems. Participate in on-call rotation for research coordinator tasks (screening, enrolling, sample processing) as needed.

Department Summary:

The Department of Pediatrics is the second largest department in the University of Utah School of Medicine and one of the largest pediatric departments in the country. We are committed to improving the lives of children through excellence in advocacy, education, research, and clinical care. For more information about the
Department of Pediatrics, please visit: http://medicine.utah.edu/pediatrics/.
Mutual respect and appreciation are highly valued in the department.

Benefits Summary:

The University of Utah offers a comprehensive benefits package including:

• Excellent health

care coverage at affordable rates (see the Summary
Comparison for more information)

-
14.2% retirement contributions

• Generous paid leave

time

• 11 paid

Holidays per year

• 50% tuition

reduction for employees, spouses, and dependent children

-
Flex spending accounts

• University provided basic employee

life insurance coverage equal to a salary of up to
$25,000

• Variety of elective insurance

coverage, including life insurance, short and long-term disability, accidental death & dismemberment, accident, critical illness, hospital indemnity, and pet.

-
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/.

Employee Health Requirements:

This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. 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.

Responsibilities

Essential Functions:Direct/Manage/Supervise the organization's clinical research operations including research coordination, monitoring, interviewing, and patient services.
Develop research studies and create standards and guidelines for clinical research services and programs, monitoring adherence to protocols. Ensure clinical research strategies, policies, and procedures are maintained. Ensure adherence to Standard Operating
Procedures (SOPs), Good Clinical Practices (GCPs), and all applicable regulations. Prepare reports and keep upper-level management informed of progress and problems.

• Prepares, submits, and maintains IRB, FDA, NIH and all other

regulatory processes to ensure compliance with good clinical research standards and practices.

• Oversees compliance with study protocols: manages quality

control, completion and submission of study-related documentation;
prepares reports for organizations and agencies.

• Supports adherence to institutional, sponsor and regulatory

requirements for human subject research.

• Recognizes, tracks and reports adverse events and protocol

deviations.

• Monitors enrollment goals and initiates strategies to promote

enrollment and participant compliance. Coordinates and carries out responsibilities related to research participants, including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, obtaining informed consent, answering subject inquiries, overseeing study visits, processing study samples, and acting as a liaison between participants and all study-related parties.

• Provides study-specific education and training for faculty,

fellows, Primary Children's Hospital clinical and ancillary staff, and students.

• Assists in assessing, planning, designing, budgeting and

initiating future studies.

• Collaborates with study sponsors and PIs to establish study

objectives, procedures, and deadlines for each project. Oversees day-to-day research activities, ensuring that progress is made to achieve study objectives and deadlines while preserving the integrity of scientific research.

• Supervises other members of the research team including

monitoring time tracking, FTE allocation, performance evaluations.
Provides training and professional development opportunities for the team.

• Collaborates with division administrator to monitor study

expenditures, order supplies, assist with budget/funding updates and analysis of appropriate expenditure of funds.

• Coordinates and prepares reports for internal and external

customers, including division chiefs, division administrator, project investigators, university offices, study sponsors and collaborating institutions.

Supervisor, Clinical ResearchCoordinates and leads daily team activities. May spend a portion of time performing the work of those they supervise. Assists with management decisions and activities. Working knowledge of team function within the organization.Requires a bachelor's (or equivalency) with up to 2 years of directly related work experience or a master's (or equivalency) degree.This is a Supervisor-Level position in the
Management track.

Disclaimer:This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It 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.

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:

Supervisor, Clinical Research: Requires a bachelor's degree (or equivalency) in a related field with up to 2 years of directly related work experience, or a master's (or equivalent) degree.

Preferences

Preferences:

• Experience with the University of Utah research infrastructure

(OnCore, ERICA, eReg, REDCap, etc.).

• CITI Training, Good Clinical Practices (GCP), HIPAA.
• 2+ years of research regulatory management including IRB

submission and maintenance experience.

• 3+ years of clinical research coordinator experience including

screening, consenting, enrolling, processing samples, and data entry.

• Demonstrated ability to manage multiple studies at a time.
• Knowledge of medical terminology.
• 1+ year of experience managing other team members.

The Department will screen applicants according to the identified preferences.

Special Instructions

Requisition Number: PRN46518B

Full Time or Part Time? Full Time

Work Schedule Summary: Generally, Monday – Friday, 8:00 a.m.
– 5:00 p.m. with need for study coverage outside of regular business hours depending on the current research portfolio of the divisions.As this position manages the research team, it is expected to primarily be an in-person position. Opportunities for a hybrid telework schedule may be considered after the initial training period, provided the arrangement is supported by operational needs and individual performance. Telework arrangements are not guaranteed and may be modified or discontinued at any time based on business requirements or performance. Employees approved for hybrid telework must provide their own private workspace, secure internet connection, and demonstrate the ability to work independently.

Department: 00850 - Pediatric Critical Care

Location: Campus

Pay Rate Range: $78,884 to $97,182

Close Date: 01/16/2027

Open Until Filled:

To apply, visit https://apptrkr.com/9904289"">https://utah.peopleadmin.com/postings/211038

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