Clinical Operations Manager - Cancer Center

University of Kansas Medical Center•Kansas City, KS

21h

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 informed consent and follow-up visits. The position helps develop and implement departmental standard operating procedures and plans and executes research operations, including deliverables, timelines, project costs, contracts, and agreements. It also assists with grant writing, budget development, and grant submissions to federal and foundation agencies, and leads cross-functional teams in support of the Cancer Center’s mission. The University of Kansas Cancer Center is the region’s only National Cancer Institute-designated Comprehensive Cancer Center and one of 58 nationally. Its patients have access to promising therapies, clinical trials, and research. The manager oversees assigned clinical trial activities and serves as a primary contact for protocol clarifications and logistical concerns. The role leads and develops staff and study teams, coordinates with sponsors and research partners, tracks project progress and deliverables, prepares reports and presentations, and supports protocol review and feasibility assessment. It also monitors compliance with institutional, sponsor, and regulatory requirements and participates in research audits and inspections.

Requirements

At least one of the following certifications: 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.
Communication, computer, project management, time management, multitasking, and leadership skills.

Nice To Haves

Master’s degree or higher in life sciences or a healthcare field.

Responsibilities

Manage assigned clinical trial activities and serve as the primary contact for those activities, protocol clarifications, and logistical project concerns.
Conduct study activities, including informed consent and follow-up visits.
Develop, understand, and manage contractual and organizational expectations and stakeholder relationships.
Assign, review, train, mentor, and provide constructive feedback to staff and study teams; manage onboarding, coaching, career development, leave requests, continuing education, and delegation of responsibilities.
Establish and assign team activities to accomplish study goals, communicate priorities, and help team members prioritize, solve problems, and plan contingencies.
Coordinate with sponsors, CROs, ancillary research departments, and other organizations involved in study and program management.
Track project progress, metrics, and deliverables; create progress reports and follow up on action items.
Prepare research reports for research personnel and funding organizations, and prepare, assist with, or lead project-status presentations for senior leadership, disease working groups, and stakeholders.
Ensure data collection and research protocols follow sponsor and institutional requirements; assure staff compliance with applicable institutional, regulatory, and other policies and practices.
Provide oversight and training for staff involved in recruitment, informed consent, protocol-required procedures, and essential documentation.
Evaluate clinical research processes, including data-management 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.
Identify, resolve, or escalate issues and liaise with senior leadership to optimize team performance.
Review and assist with editing new protocols and assess protocol 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 submission of grant requests 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.
Paid vacation and sick time accruing upon hire.
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.
Retirement program with an employer contribution.
Additional voluntary retirement programs (457 or 403b).