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 research network studies and trials at various clinical sites. Assists in the development of research projects, scientific study design, data interpretation, 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. Licensed professionals may perform medical reviews and analyze or evaluate clinical data.

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 4 years of clinical research experience that includes project management. Experience with human subjects research, good leadership skills, and working knowledge of FDA, ICH, and other regulatory compliance are also required. Must have excellent interpersonal and communications 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. Independently provides oversight for all aspects of study conduct, regulatory compliance, and record keeping processes at the site or institution level. 
2. Assures regulatory compliance for the data coordinating center
3. Maintains research data files and regulatory documents for all clinical trial sites.
4. Identifies and creates queries to improve data capture and assists in developing methods to clarify/clean existing data
5. Reviews site monitoring reports and discusses findings with Study Investigators and offers suggestions and solutions to problems, concerns, or recurrent trends or themes
6. Assures that adverse events are reported to the sponsor
7. Reviews site records for accuracy regarding test article accountability
8. Develops study specific network guidelines and Standard Operating Procedures
9. Organizes study trainings and gives presentations to employees and other research coordinators on good clinical practices and study procedure implementation
10. Acts as liaison between study Investigators and sponsors to communicate and resolve issues
11. Assumes considerable leadership responsibilities of studies throughout the network
12. Provides feedback on study site performance, compliance, and data quality
13. Makes recommendations regarding site disciplinary actions, which may result in site monitoring visits, suspension, or discontinuation of a study site
14. Performs remote site monitoring activities independently
15. Licensed professionals may be assigned medical reviews
16. Must be able to perform the essential functions of a Level 1 Project Manager

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. The 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.