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Quality Assurance Project Manager - Cancer Center
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University of Kansas Medical Center
Kansas City, KS (In Person)
Full-Time
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Job Description
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. 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. Masters or higher degree in life sciences or healthcare field. Time management. Multitasking. Collaboration. Oral and written communication. Computer skills.