Clinical Operations Manager - Cancer Center

University of Kansas Medical Center•Kansas City, MO

8d•$80,600 - $120,900

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 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 position manages assigned clinical trial activities and serves as the primary contact for protocol clarifications and logistical concerns. It assigns, trains, mentors, and develops staff and study teams; coordinates with sponsors, CROs, and research partners; tracks project progress and deliverables; prepares reports and presentations; supports protocol review and feasibility assessment; and contributes to study budgeting and resource planning. The manager helps ensure compliance with institutional, regulatory, sponsor, and protocol requirements, and participates in research audits and inspections. The University of Kansas Cancer Center is the region’s only National Cancer Institute-designated Comprehensive Cancer Center and is one of 58 such centers in the nation.

Requirements

Eight years of relevant work experience; education may be substituted for experience on a year-for-year basis.
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).
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 life sciences or a healthcare field.

Responsibilities

Manage assigned clinical trial activities and serve as the primary contact for protocol clarifications and logistical project concerns.
Conduct study activities, including consenting and follow-up visits.
Develop, understand, and manage contractual and organizational expectations, while supporting internal and external stakeholder relationships.
Assign, review, and train staff and study teams; use escalation and performance plans as needed; and mentor junior staff.
Develop direct reports through onboarding, mentoring, coaching, career-path management, continuing education, and delegation.
Communicate across teams and reporting structures within the Clinical Trials Office.
Help team members prioritize, solve problems, and plan contingencies; delegate work while retaining ownership; and communicate findings and priorities.
Liaise with senior leadership to optimize project team performance.
Ensure employees comply with KUMC, regulatory, and other applicable policies and approved practices.
Provide oversight and training for recruitment, informed consent, protocol-required 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 research personnel and funding organizations.
Ensure data collection and research protocols comply with sponsor and institutional requirements.
Evaluate the clinical research matrix, including data-management query resolution timelines and non-compliance reports, to 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, and lead project-status presentations; and follow up on action items.
Identify, resolve, or escalate issues.
Review and assist with editing new protocols and assess study feasibility, including patient population, budget, and study-specific needs.
Assist with study budget preparation and resource planning.
Monitor adherence to 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 generous employer contributions for employees participating in a qualifying health plan.
Employer-paid life insurance.
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 a generous employer contribution.
Additional voluntary retirement programs (457 or 403b).