University of Utah Job Description
**This job code is for use in Department of Pediatrics areas ONLY.**
Independently manages and coordinates complex interventional studies or research networks. 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. Independently develops new budgets and oversees budget expenditures. Leads and direct efforts to improve workflow, study team function, implementation of clinical studies across the organization. Collaborates with other data center staff and faculty leads to improve processes and standards involved in project management. Develops metrics and evaluates progress and development of research projects and larger research programs to assure standardization and efficiency across the organization. Manages several projects simultaneously meeting deadlines and managing deliverables.
Licensed professionals may perform medical reviews and analyze or evaluate clinical data.
Bachelor’s degree in a health science field, or equivalency (one year of education can be substituted for two years of related work experience), credentialing as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or Certified Clinical Research Associate (CCRA) or other related certification, AND
10 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 such as electronic data capture software, Query Manager, LaTeX, etc., which will be taught on the job.
Preference will be given to candidates having a Master’s degree in a health or related area, or with project management experience and/or certification.
Depending on the area of assignment, current medical licensure may be preferred.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
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.
The position will be making independent decisions regarding data issues, study procedures and protocol issues and will be managing multiple complex projects and overseeing aspects of more risky projects. This position handles complex issues that may have no clear precedent and requires extensive consideration of study implications. This role may assist with new solutions or policies and is expected to make improvements to existing professional standards.
Provides input on site performance, compliance and data quality. Makes recommendations for disciplinary action, which may result in a site monitoring visit, suspension or discontinuation of a study site.
Determines when to escalate issues to Study Principal Investigator or DCC Principal Investigator about study risks.
This position will frequently provide training, public speaking and interface with industry and academic investigators. Uses influence and active persuasion. Influences program wide decisions. De- escalates or avoids highly charged situations; Uses influence and active persuasion. Influences program wide decisions.
Develops strategies toward customer service across the program or division or department. Able to deal with difficult personalities. Responds to customer service needs without compromising deliverables.
Strategic thinking and Innovation
Key partner with leaders to form strategic direction and guide initiatives; pro-actively seeks new opportunities to grow and expand; initiates solutions to solve problems and strategically help the organization; shares knowledge nationally and with other departments as applicable.
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.
250 East 200 South, Suite 125,
Salt Lake City, Utah 84111
Phone: 801.581.2169 Email: AskHR@utah.edu
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