Clinical Research Management

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Job Summary

• 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

Responsibilities

1. Prepares, submits, and maintains IRB, FDA, NIH and all other regulatory processes to ensure compliance with good clinical research standards and practices.
2. Oversees compliance with study protocols: manages quality control, completion and submission of study-related documentation; prepares reports for organizations and agencies.
3. Supports adherence to institutional, sponsor and regulatory requirements for human subject research.
4. Recognizes, tracks and reports adverse events and protocol deviations.
5. 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.
6. Provides study-specific education and training for faculty, fellows, Primary Children’s Hospital clinical and ancillary staff, and students.
7. Assists in assessing, planning, designing, budgeting and initiating future studies.
8. 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.
9. Supervises other members of the research team including monitoring time tracking, FTE allocation, performance evaluations. Provides training and professional development opportunities for the team.
10. Collaborates with division administrator to monitor study expenditures, order supplies, assist with budget/funding updates and analysis of appropriate expenditure of funds.
11. Coordinates and prepares reports for internal and external customers, including division chiefs, division administrator, project investigators, university offices, study sponsors and collaborating institutions.

Minimum Qualifications

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.

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Additional Information