Quality Assurance Project Manager - Cancer Center

University of Kansas Medical Center • Kansas City, KS

2d • Hybrid

About The Position

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.

Requirements

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

Nice To Haves

• Masters or higher degree in life sciences or healthcare field.
• Time management.
• Multitasking.
• Collaboration.
• Oral and written communication.
• Computer skills.

Responsibilities

• 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.
• 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.

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 after six months of employment
• paid time off for bereavement, jury duty, military service, and parental leave after 12 months of employment
• A retirement program with a generous employer contribution
• additional voluntary retirement programs (457 or 403b)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level