Clinical Operations Manager - Cancer Center
About The Position
The Clinical Operations Manager manages clinical research activities led by investigators and faculty in the Cancer Center research program. This is a working manager role that also conducts study activities, including consenting participants and follow-up visits. The manager assists with developing and implementing departmental standard operating procedures and plans and executes research operations, including deliverables, timelines, project costs, contracts, and agreements. The role also assists with grant writing, budget creation, and grant submissions to federal and foundation agencies, and leads cross-functional teams in support of the Cancer Center’s mission. The manager oversees assigned clinical trial activities and serves as a primary contact for protocol clarifications and logistical concerns. The position trains, mentors, and develops staff and study teams; coordinates with sponsors, CROs, and research partners; monitors project progress and deliverables; and supports protocol review, study feasibility, budgeting, resource planning, audits, and regulatory compliance. The University of Kansas Cancer Center is the region’s only National Cancer Institute-designated Comprehensive Cancer Center.
Requirements
- One or more of the following certifications or credentials: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or Association of Clinical Research Professionals (ACRP).
- Eight years of relevant work experience; education may substitute for experience on a year-for-year basis.
- Experience with FDA regulations and ICH-GCP guidelines.
- 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.
- Skills in communication, computer use, project management, time management, multitasking, and leadership.
Nice To Haves
- Master’s degree or higher in a life sciences or healthcare field.
Responsibilities
- Manage assigned clinical trial activities and serve as the primary contact for protocol clarifications and project logistics.
- Conduct study activities, including informed consent and follow-up visits.
- Assign, review, and train staff and study teams; mentor junior staff and provide constructive feedback.
- Develop direct reports through onboarding, mentoring, coaching, career-path management, continuing education, and delegation.
- Communicate across team members and reporting structures within the Clinical Trials Office.
- Mentor team members in prioritization, problem-solving, contingency planning, and delegated work; liaise with senior leadership to optimize team performance.
- Ensure employees comply with institutional, regulatory, and other applicable policies and approved practices.
- Provide oversight and training for recruitment, informed consent, protocol procedures, and essential documentation.
- Coordinate with sponsors, CROs, ancillary research departments, and other organizations involved in study and program management.
- Track project progress, create progress reports, and prepare research reports for personnel and funding organizations.
- Ensure data collection and research protocols follow sponsor and institutional requirements.
- Evaluate research operations, including query-resolution timelines and non-compliance reports, and develop corrective and preventive actions and departmental processes.
- Participate in internal and external research audits and inspections.
- Monitor project metrics and deliverables; prepare, assist with, or lead status presentations for leadership and stakeholders, and follow up on action items.
- Identify, resolve, or escalate project issues.
- Review and edit protocols and assess study feasibility, including patient population, budget, and study-specific needs.
- Assist with study budget preparation and resource planning.
- Monitor compliance with departmental operational policies and guidelines.
- Assist with grant writing, budget creation, and grant-request submissions to federal and foundation agencies.
- Assist in developing and implementing departmental standard operating procedures.
Benefits
- Health, dental, and vision insurance coverage beginning on day one.
- Health expense accounts with employer contributions for employees participating in a qualifying health plan.
- Employer-paid life insurance and long-term disability insurance.
- Additional voluntary insurance plans.
- Accruing vacation and sick leave beginning upon hire.
- Ten paid holidays.
- One paid discretionary day after six months of employment.
- Paid bereavement, jury duty, military service, and parental leave after 12 months of employment.
- Retirement program with an employer contribution.
- Additional voluntary retirement programs (457 or 403b).
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
