Job Description

University of Utah Job Description

Job Summary

**This job code is for use in Department of Pediatrics areas ONLY.**

Independently manages and coordinates complex interventional network studies and trials at various clinical sites. Assists in the development of research projects, scientific study design, protocol development, data interpretation and analysis, training of research site personnel, and maintains regulatory compliance, patient safety, and data quality. Monitors the conduct and progress of studies to ensure compliance with established protocols and study timelines. Provides mentoring and leadership for junior team members. Licensed professionals may perform medical reviews and analyze or evaluate clinical data.

Qualifications

Bachelor’s degree in a health science field, or equivalency, credentialing as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), Project Managment Professional (PMP), or other related certification, AND 6 years clinical research experience that includes project management. Knowledge of FDA, ICH, and other regulatory guidelines, experience in writing research materials, excellent leadership skills, as well as excellent interpersonal and communication skills are also required. Must be proficient in Microsoft Office and possess the ability to learn new software programs.

Preference will be given to candidates having a Master’s degree in a health related area.

Depending on the area of assignment, current medical license may be preferred. Licensed professionals must have a current registration or licensure in the State of Utah as required by the profession.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

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.

Essential Functions

1. Assists network clinical investigators and research coordinators with the development of scientific research projects and oversees protocol development
2. Works with investigators to design data collection tools and other data elements.
3. Prepares, submits, and maintains regulatory documents and research correspondence
4. Assesses quality patient safety issues related to the data and develops intervention plans as necessary
5. Conducts site monitoring visits or assists with visits to clinical sites to ensure protocol and regulatory compliance, data quality, and patient safety
6. Completes detailed reports of monitoring findings
7. Analyzes and evaluates clinical data
8. Licensed professionals may be assigned medical reviews
9. Leads and mentors junior team members
10. Assists Project Director with all orientation and training of new team members
11. Must be able to perform the essential functions of level 1 and 2 Project Managers.

Problem Solving

This position makes independent decisions regarding data issues, study procedures and protocol issues as well as recognizing and resolving protocol deviations. It provides input on site performance, compliance and data quality. This position also makes recommendations for disciplinary action, which may result in a site monitoring visit, suspension or discontinuation of a study site. Determines when to involve Study Principal Investigator or DCC Principal Investigator about issues/concerns that arise at the study sites and develops methods to resolve data discrepancies.

Comments

This position requires expertise and interpretation of laws, federal regulations, ICH guidelines and Good Clinical Practice guidelines to provide direction/guidance/supervision to study sites. Ensures the sites are compliant with protocol, federal regulations, ICH guidelines, Good Clinical Practice guidelines and local IRB requirements.