Job Description

University of Utah Job Description

Job Summary

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

Under the guidance of the Program Manager, manages and coordinates research network studies and trials at various clinical sites. Monitors the conduct and progress of studies to ensure compliance with established protocols and study timelines. May assist in the development of research projects, scientific study design, data interpretation, training of research site personnel, and maintain regulatory compliance, patient safety, and data quality.

Qualifications

Bachelor’s degree in a health science field, or equivalency (one year of education can be substituted for two years of related work experience) AND 2 years of clinical research experience. Experience with human subjects research preferred. Must have excellent interpersonal and communication skills, both oral and written. Must be proficient in Microsoft Office and possess the ability to learn new software programs.

Credentialing as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), Project Management Professional (PMP), or other related certification is highly preferred, along with experience in the specific clinical research 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.

This position is not responsible for providing patient care.

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. Under the guidance of the Program Manager, provides oversight for all aspects of study conduct, regulatory compliance, and record keeping processes at the site or institution level.
2. Prepares, submits, and maintains IRB, FDA, and other regulatory documents and research correspondence.
3. Reviews site files and records for completeness, accuracy, consistency and compliance; identifies deficiencies or discrepancies and facilitates their resolution
4. Assures that adverse events are reported to the sponsor
5. Works with programmers to develop and test databases and other collection tools
6. Analyzes incoming data to identify trends, problems, or other issues
7. Prepares and interprets reports and queries for Investigators and Research Coordinators, which include, but not limited to monthly enrollment reports, reports of various data elements, query reports, etc.
8. Ensures that captured data is accurate and corrects erroneous or conflicting data
9. Communicates with study sites frequently to discuss and follow-up on data issues and troubleshoots possible solutions.
10. Works with site monitors to ensure protocol and regulatory compliance, data quality, and patient safety
11. Performs remote monitoring of site data in coordination with appropriate personnel
12. Attends required meetings and conferences as appropriate
13. Licensed professionals may be assigned medical reviews

Problem Solving

May provide input on site performance, compliance and data quality

Comments

Day to day challenges include helping remote research sites enroll patients successfully, providing guidance and assuring compliance with IRB standards, the protocol, and national clinical research regulations.

Licensed professionals may perform medical reviews and analyze or evaluate clinical data.