Program Director

Department:

SOM KC Cancer Center Clinical Trials

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Clinical Trials, Clinical Trials Operations

Position Title:

Program Director - Cancer Center

Job Family Group:

Professional Staff

Job Description Summary:

The Program Director reports to the Research Project Director and is responsible for the execution and oversight of clinical trial operations and clinical research coordinator conduct for all clinical trials from initiation through to closeout. The Program Director manages a division clinical program portfolio as assigned by leadership and ensures that all clinical and departmental operations are conducted according to the mission of the Cancer Center to achieve excellence in clinical activities in the delivery of patient care and services. 

The University of Kansas Cancer Center is the only National Cancer Institute designated Comprehensive Cancer Center in the region, 1 of only 57 in the nation to receive this distinction. Patients gain access to the most promising therapies, cutting-edge clinical trials and world class research. 

Job Description:

Job Duties Outlined

• Perform functional management duties of a clinical program portfolio as assigned by leadership.

• Primary contact for all protocol clarifications and logistical project related concerns.

• Develop direct reports through initial on-board training, regular 1:1 mentoring and coaching, career path management, leave requests, continuing education and delegation of responsibility.

• Communicate effectively laterally across the team as well as up and down reporting structures within the Clinical Trials Office (CTO).

• Motivate the project team to commit to a common purpose, performance goals and approach for which all hold themselves individually and mutually accountable. Manage contractual and organizational client expectations.

• Balance workloads, ensure tracking systems are up to date, assist team members with prioritization, problem solving and resourcing. Delegate activities while retaining ownership. Liaise with CTO management to optimize performance of project team members. 

• Provide project support and manage cross-functional team members. Prepares agenda, manages and facilitates assigned Disease Working Group (DWG) meetings. Aids in study budget preparation and resource planning to accomplish study objectives.

• Manage team study pipeline and prepare and present prospective trials to the Executive Review Committee (ERC). Actively participate in Project Director, Departmental, Coordinator, Team and Staff meetings. 

• Support upper management through the use of effective tracking tools to provide consistent and accurate project status. Participate in Ad hoc projects as assigned.

• Assist Sponsor with scheduling of monitoring visits: Site Initiation Visit, Interim Monitoring Visit, and Close Out Visit. Promote project continuity by facilitating the internal kick-off meeting (KOM) and other training as required by protocol updates.

• Develop, review and update policies, procedures, process improvement, training and evaluations that help support clinic workflows, productivity, quality improvement and customer service.

• Triage and resolve clinical, research and data concerns, issues.  Escalate to senior leaders as appropriate. 

• Contribute to division program resource planning to accomplish institutional objectives.  Interface with Cancer Center finance team for coverage analysis process and financial feasibility for each study.

• Collaborate with other directors and managers and health system departments. 

• Develop or review study management plans as needed. Ensure compliance with study tools, training materials as well as institutional standard processes, policies and procedures 

• Maintain proficiency in workflows of clinic, Epic/Beacon, and any other systems required for scheduling, screening and treating new clinical trial patients.  

• Assist leadership in the development of Standard Operating Procedures and Working Practice Guidelines related to clinical trial referral process.

• Document all communication (i.e. telephone and other) with patients per University and Health System policies. 

• Attend study specific safety calls and provide updates on clinical trial participants.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice

Required Qualifications

Certifications: One of the following:

• Certified Clinical Research Coordinator (CCRC).

• Certified Clinical Research Professional (CCRP).

Work Experience: 

• 9 years clinical trial experience within the pharmaceutical industry or academia.  Education may substitute for experience on a year for year basis.

• Experience with FDA regulations and ICH-GCP guidelines.

• Prior experience managing a staff and working with physicians on clinical trials.

• Experience with study budgets, contracts and grant applications.

• Experience with statutes and guidelines relevant to regulatory affairs in clinical research.

• Experience with medical terminology and investigative scientific methods.

• Experience with clinical research databases and software for managing projects and resources. 

• Experience with Electronic Medical Record charting. 

Preferred Qualifications

Education: Bachelor’s degree.

Work Experience:  

• Experience with Clinical Trials Management Systems. 

Skills

• Communication.

• Collaboration.

• Attention to detail.

• Time management.

• Organization.

• Computer skills.

• Interpersonal skills.

If selected as a final candidate for this position, you may be required to complete the Association of American of Universities Representations and Warranties document and sign a release of records that will allow the University of Kansas Medical Center to conduct a further background check with former employers.  A copy of the Representations and Warranties document can be found here.

Comprehensive Benefits Package:

Employee Type:

Regular

Time Type:

Full time

Rate Type:

Salary

Compensation Statement:

The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above. 

Pay Range:

$83,000.00 - $131,000.00

Minimum

$83,000.00

Midpoint

$107,000.00

Maximum

$131,000.00