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.

Develops new budgets and oversees budget expenditures. 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. Manages several projects simultaneously meeting deadlines and managing deliverables.

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), or Certified Clinical Research Associate (CCRA) or other related certification, AND

8 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.

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. Develops and independently manages multiple or complex research programs and/or projects as a part of the data coordinating center, including clinical trials
2. Manages program or project milestones and goals, and assures overall customer service and delivery of research products.
3. Provides budget oversight to multiple, potentially complex studies
4. Oversees IRB and sIRB activities assuring all regulations and site requirements are followed.
5. Provides oversight and management of budget requirements; able to anticipate project expenditures and adjust as needed.
6. Manages and coordinates complex interventional research studies or research networks assuring risk management and timely risk mitigation. Anticipates and oversees risks to patient safety; thoroughly understands and provides oversight and training to investigators and site staff on the SAE reporting Works closely with medical monitor or oversees the medical monitoring activities.
7. Monitors study conduct in all areas including compliance, data integrity, safety, protocol adherence, customer service, and assures adequate enrollment in studies and projects. Escalates deviations and any new risks to study leadership
8. Demonstrates critical thinking, anticipation of problems and relevant interventions; escalates deviations and any new risks to study leadership.
9. Recognizes when study or team processes need to be improved and leads efforts to evaluate and change approaches and methods.
10. Demonstrates the ability to successfully provide mentoring, leadership, training and professional growth for junior team members and provide direct verbal feedback
11. Assists with protocol and grant development process, understanding key aspects of the grant and protocol requirements
12. Directly communicates with the sponsor to outline goals, milestone delivery, and assure completion of research project(s). Resolves issues or problems to satisfaction of customer or leaders.
13. Independently guides sites regarding protocol and regulatory compliance
14. Independently contributes to developing budgets before execution and provides accurate information to financial analysts, directors and PI during study period.
15. Ability to guide, motivate, and direct a team without formal authority
16. Anticipates data issues and facilitates development of intervention plans. Assures completion of risk assessment/management Strategizes about program and project goals and assures overall customer service.
17. May participate in manuscript writing and review.
18. Must be able to perform the essential functions of level 1, 2 and 3 Project Manager positions

Problem Solving

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.

Communication

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.

Customer Service

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.

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.