Clinical Operations Manager

Department:SOM KC Cancer Center Clinical Trials

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Clinical Trials Clinical OperationsPosition Title:Clinical Operations Manager -Cancer CenterJob Family Group: Professional StaffJob Description Summary:The Clinical Operations Manager will manage clinical research activities led by investigator(s) and faculty in the Cancer Center research program. This is a working manager role and will also be responsible for conducting study activities including consenting, follow  up visits, etc. The manager will assist in the development and implementation of departmental standard operating procedures. Responsibilities include planning and executing operational aspects of research within the department, including managing deliverable, timelines, oversight of project costs, contracts, and agreements. This position assists in grant writing, budget creation, and submission of grant requests to federal and foundation agencies.  This role will lead 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 protocol clarifications and logistical project related concerns.

• Conduct study activities, including consenting, follow up visits, etc.

• 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.

• Communicate effectively laterally across the team as well as up and down reporting structures within the Clinical Trials Office (CTO).

• 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. 

• Evaluate 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. 

• Aid in study budgetary preparation and resource planning needs to accomplish study objectives. 

• 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. 

Required Qualifications

Certifications/Licenses: One or more of the following:

• Certified Clinical Research Coordinator (CCRC)

• Certified Clinical Research Professional (CCRP).

Work Experience:

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

• Experience with FDA regulations, ICH-GCP guidelines, and KUMC policies and practices.

• 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.

Preferred Qualifications

Education: Masters or higher degree in life sciences or healthcare field.

Skills

• Communication.

• Computer skills.

• Project management.

• Time management.

• Multitasking.

• Management.

Required Documents

• 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.

Employee Type: RegularTime Type: Full timeRate 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:$75, $115,000.00

Minimum

$75,000.00

Midpoint

$95,000.00

Maximum

$115,000.00

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