Director of Clinical Research Operations

At Urology America, our mission is to support our physician partners in building a premier urology organization that delivers best-in-class patient care and experience, is nationally recognized for its clinical capabilities, and excels in operational performance and growth.

By choosing a career with Urology America and its affiliated practices, you are joining a collaborative, team-driven organization committed to innovation, quality, and compassionate care. Together, we are improving the lives of patients and their families through better medicine and better care, wherever we serve.

Job Summary:

The Clinical Research Operations Director oversees the coordination, management, and strategic growth of clinical research operations across all Urology America markets. Under the direction of the Vice President of Research, this role is responsible for ensuring the successful execution of clinical trials, while managing research staffing, systems, billing and collections, and site expansion efforts. The Operations Director plays a key leadership role in driving operational excellence and advancing the growth of Urology America’s clinical research network.

Job Relationships:

• Reports directly to the VP of Research and indirectly to the Urology America leadership. This role is also responsible to the individual market presidents, the Principal Investigators of each trial, and the physician partners of each practice.
• Able to collaborate with clinical providers, staff and leadership at local sites, research coordinators, patient navigators, IT, and data management
  
  

Qualifications:

• Must have ≥ 7 years experience in clinical trials
• Three to five years of research management including program development and implementation
• Master’s degree in a business, health or a science field.
• Willing to travel as needed to all Urology America research sites, and to meetings/conferences
• Urology based clinical experience preferred but not required
• Experience with evaluating and implementing study protocols and budgets
• Must have knowledge of and experience with relevant federal and state regulatory guidelines
• Proficiency in computer software including Microsoft Office Suite, EMR, Practice Management, Electronic Data Capture (EDC), and Clinical Trail Management Systems (CTMS). Experience with use and implementation of AI platforms is preferred
• Exceptional time management skills and the ability to prioritize work
• Excellent communication skills and the ability to interact with all levels of management, staff, sponsors, and providers
  
  

Job Duties:

• Work to build the research department in scope, size, reputation/professionalism at each site
• Oversight of managers and research coordinators and department Specialists.
• Able to collaborate with clinical providers, staff at local sites (specifically the clinical managers and site leadership,) patient navigators, IT, and data management
• Ensure that Urology America Research studies, processes, workflows, software, structures are integrated and running at all sites. The Operations Director will need to travel occasionally to each site to ensure successful integration of the above.
• Interact with study sponsors as needed regarding budgets, invoicing, monitoring, audits, etc
• Ensure managers, leadership personnel, and all staff work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements. Conduct regular evaluations of direct reports.
• Design, implement, and manage systems for organizing, planning, and controlling workflow related to all clinical research activities, specifically for screening, enrollment, tracking, etc.
• Identifies financial goals and other relevant KPI’s and develops dashboards to measure Research Department progress or opportunities for improvement.
• Maintain study budgets and monitor invoices, billing, and payments, in collaboration with the accounting department to ensure timely and accurate A/R process
• Monitors all Urology America research-related financial accounts, meeting regularly with accounting, and ensures study revenue is meeting projections.
• Negotiates and approves all subcontracts with collaborators/investigators and facilities
• Evaluate, purchase, maintain necessary equipment, and equipment monitoring
• Provides project management planning for new projects/trials and works collaboratively with the Managers to ensure clinical staff are educated on all process changes
• Manages research software to ensure it is implemented and is being used to its full capacity. Includes problem solving, workflow and change management oversite and vendor management.
• Participate in business development in analysis and selection of opportunities.
• Recognize, exemplify and adhere to Urology America Research’s values that center on our commitment to quality, our team, our patients and department growth and performance
• Maintain HIPAA compliant communication and confidentiality, at all times
• Assist with other duties assigned
  
  

Performance Requirements:

Knowledge

• Experience in a large and dynamic organization, especially with business and financial aspects, roles, organizational charts, delegation, and workflows
• Knowledge of health care field; medical practice clinical and administrative systems, clinical research field, and sponsor requirements for successful clinical trial completion
• Understanding of medical and research terminology
  
  

Skills

• Excellence in computer and software systems both in the use and in the evaluation, selection, and integration of these systems
• Interpersonal and communication both with internal staff and external customers
• Skill in evaluating and implementing study protocols and budgets
• Basic skill in reading and interpretation of medical terminology
• Excellent organizational and time management skills
• Outstanding verbal and written communication skills
  
  

Abilities

• Ability to communicate effectively with leadership, staff, and external contacts via phone, in person, and through electronic mail
• Ability to plan, exercise initiative, problem solve, make decisions
• Ability to read and understand information and ideas presented in writing
• Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning
• Ability to identify problems and recommend solutions
• Ability to establish priorities and coordinate work activities
• Ability to manage financial information
  
  

Reporting to this Position:

Once the planned organizational chart is fully hired, it is expected that there will be multiple site managers, the Financial Specialist, the Regulatory/QA Specialist, and the Recruitment Specialist reporting directly to the Director of Operations.

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions:

• Physical demands: Involves sitting approximately 70-90 percent of the day, walking or standing for the remainder. Work may require stooping and bending, mobility to complete patient study visits, and lifting up to 40 pounds.
• Work environment: Primarily office setting, with time in the clinical setting for patient study visits. Noise level in the work environment is usually moderate. Clean, well-lighted office/clinical environment.
• Will require travel to all Urology America research and clinical locations to meet department demands
  
  

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