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Kansas City Metro Area, United States of America
Onsite
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KMCRI-AdministrationJob 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.
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.
Education:
Masters or higher degree in life sciences or healthcare field.
Skills:
Time management.
Multitasking.
Collaboration.
Oral and written communication.
Computer skills.
Resume/CV
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
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.
Minimum
$80,600.00Midpoint
$100,800.00Maximum
$120,900.00
