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 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.

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

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.

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. Leads protocol development with a focus on de-risking
2. Strategizes about program or project milestones and goals, and assures overall customer service and delivery of research products.
3. Provides oversight to multiple, potentially complex studies and study teams to assure meeting of milestones and budget requirements
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 complex interventional research studies or research networks assuring team understanding of 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. 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.
8. Demonstrates critical thinking, anticipation and intervention to minimize problems; escalates deviations and any new risks to study leadership.
9. Recognizes when study or team processes need to be improved and leads efforts to empower and lead study team to make changes.
10. Analyzes and evaluates clinical data and mentors staff to interpret data findings and implement
11. Demonstrates the ability to successfully provide mentoring, leadership, training and professional growth for junior team members and provide direct verbal feedback; May provide feedback for staff evaluation as appropriate.
12. Demonstrates ability to guide and contribute to protocol and grant development process, understanding key aspects of the grant and protocol requirements; able to explain protocol and grant concepts to junior investigators
13. Directly communicates with the sponsor outlining goals, milestone delivery, and develops ongoing metrics of research programs. Resolves issues or problems to satisfaction of customer or leaders. Interacts with sponsors and industry clients to plan studies and budgets, address regulatory needs and assesses risks and benefits to the organization.
14. Independently manages complex budgets before and during project execution and provides accurate information to financial analysts, directors, and funding agency
15. Expertly guides, motivates, and directs a team or group without formal authority
16. Demonstrates the ability to implement innovative approaches to improve workflow, efficiency, workload and enhance support of clinical trials. Leads or oversees initiatives to systematically improve work product.
17. Licensed professionals may be assigned medical
18. May participate in manuscript writing and review.
19. Must be able to perform the essential functions of level 1, 2, 3 and 4 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; shares knowledge nationally and with other departments as applicable.  

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.