HMCT Program Director - Cancer Center

University of Kansas Medical Center•Kansas City, MO

1d•$92,800 - $139,200•Onsite

About The Position

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. The University of Kansas Cancer Center is the region's only National Cancer Institute-designated comprehensive cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.

Requirements

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

Nice To Haves

Registered Nurse (RN)
Bachelor's degree in science major (blood cancer research or nurse experience) or related degree.
Experience with Clinical Trials Management Systems.

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.

Benefits

health, dental, and vision insurance
health expense accounts with generous employer contributions
Employer-paid life insurance
long-term disability insurance
various additional voluntary insurance plans
Paid time off, including vacation and sick
ten paid holidays
One paid discretionary day is available after six months of employment
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
additional voluntary retirement programs (457 or 403b)