Quality Assurance Project Manager - Cancer Center

Department:

SOM KC Cancer Center Administration

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KMCRI-Administration

Position Title:

Quality Assurance Project Manager - Cancer Center

Job Family Group:

Professional Staff

Job Description Summary:

The Quality Assurance Project Manager will manage all aspects of quality control and measures as applicable to clinical research activities led by investigator(s) and faculty in the Cancer Center research program. This position is a working manager role and will assist in the development and implementation of departmental standard operating procedures. Responsible for planning and executing operational aspects of research within the department, including managing deliverable, timelines, oversight of project costs, contracts, and agreements. Responsible for leading cross-functional teams all in support of achieving the Cancer Center’s mission.


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:

• Manage and serve as primary contact for assigned clinical trial activities. Develop, understand and manage contractual and organizational expectations; nurture internal and external stakeholder relationships and needs.  Primary contact for all quality assurance, control and compliance related concerns.

• This is a working manager position so will be responsible for conducting quality assurance and control study activities including auditing or monitoring.

• Assign, review, and train individual staff and multiple study teams. Employ escalation and performance plans as needed. Serve as expert mentor to junior staff. Establish and assign the activities of multiple teams to accomplish study goals. Provide constructive feedback to team members. 

• 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.

• Mentor team members to prioritize, solve problems, and plan contingencies. Delegate activities while retaining ownership. Communicate project findings and priorities. Liaise with senior leadership to optimize performance of project team members. 

• Assure employees in area of responsibility comply with all KUMC, regulatory and other appropriate policies and approved practices. 

• Provide oversight and training to team members who are responsible for recruitment, obtaining informed consent, performing protocol required study procedures, maintaining essential documentation. 

• Coordinate and communicate with sponsor, CRO, and ancillary research departments and organizations involved in the day- to- day study and program management. 

• Track progress of projects and create progress reports.  Prepare research reports for research personnel and funding organizations. Ensure the data collection and research protocols follow all sponsor and institution protocols. 

• Evaluates clinical research matrix, including data management query resolution timelines and non-compliance reports for the development of Corrective and Preventive Action and departmental processes.

• Participate in internal and external research audits and inspections. 

• Manage project deliverables by monitoring metrics. Prepare, assist, and lead presentations of internal project status to senior leadership, disease working groups, and other stakeholders as needed. Be accountable for follow-up on action items. Take the initiative in identifying, resolving, or escalating issues. 

• Review and assist with editing of new protocols. Assess feasibility of research protocol, including reviewing appropriate patient population, budget and specific needs for the study. 

• Monitor observance of departmental operational policies and guidelines. 

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. 

Work Environment:
This position may be eligible for a hybrid work schedule after 6 months. Incumbent will work remotely and on campus based on a set departmental schedule based on management approval and must reside in the greater Kansas City metropolitan area.

Required Qualifications:

Work Experience:

• 8 years of relevant work experience. Education may be substituted for experience on a year for year basis.

• Experience with FDA regulations and ICH-GCP guidelines.

• Experience working with cross functional teams in managing projects.

• Demonstrated ability to manage several project teams and competing priorities simultaneously. 

Certifications/Licenses:

• Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP) or other related research certification.

Preferred Qualifications:

Education:

• Masters or higher degree in life sciences or healthcare field.

Skills:

• Time management.

• Multitasking.

• Collaboration.

• Oral and written communication.

• Computer skills.

Required Documents:

• Resume/CV

• Cover Letter

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:

$80,600.00 - $120,900.00

Minimum

$80,600.00

Midpoint

$100,800.00

Maximum

$120,900.00