Department:
SOM KC Cancer Center Clinical Trials

Clinical Trials Clinical OperationsPosition Title:
HMCT Program Director - Cancer CenterJob Family Group:
Professional StaffJob Description Summary:
The Hematologic Malignancies Cellular Therapeutics (HMCT) Program Director 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 HMCT 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.

Job Description:

Job Responsibilities:

• 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.
• Develops organizational staffing plans and ensures that employees with the appropriate experience and skills are hired, onboarded, trained, supervised, have individual goals and development plans; conducts annual performance evaluations and where necessary implements appropriate employee discipline.
• Ensures area employees conduct activities in a professional and ethical manner, and in accordance with university policies and applicable local, state, and federal laws and regulations.
• Ensures all work performed by employees in the area is done in a safe and secure manner.
• Directs coordination of area work with other areas of the university to ensure integration and support of university goals and objectives.
• Maintains personal level of subject matter expertise necessary to ensure the area activities are conducted on a best practices basis.
• Participates in relevant committees, task force, or other similar activities.
• Maintains the confidentiality of medical center, employee, and patient information. Manages sensitive data with discretion and in accordance with KUMC policies and legal requirements.
• Maintains the highest standards of integrity, respect, professional conduct, and ethical standards.

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/Licenses:

One of the following:

• Certified Clinical Research Coordinator (CCRC).
• Certified Clinical Research Professional (CCRP).
• TCTCN (Transplantation and Cellular Therapy Certified Nurse)
• OCN (Oncology Certified Nurse)

Work Experience:

• Nine (9) years of experience within HMCT, blood cancer, 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

Certifications/Licenses:

• Registered Nurse (RN)

Education:

• Bachelor's degree in science major (blood cancer research or nurse experience) or related degree.

Work Experience:

• Experience with Clinical Trials Management Systems.

Skills

• Communication
• Collaboration
• Detail oriented
• Time management
• Organization
• Computer literacy

Required Documents

• Resume
• Cover Letter

Comprehensive Benefits Package:

Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. https://www.kumc.edu/human-resources/benefits.html

Employee Type:
RegularTime Type:
Full timeRate 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:
$92,800.00 - $139,200.00
Minimum
$92,800.00
Midpoint
$116,000.00
Maximum
$139,200.00