Clinical Operations Director

About the role

This position provides clinical operational oversight of the Cancer Center Clinical Trials Office (CTO), including direct responsibility for all clinical trials operations within the current Central Region of Northwestern Medicine. Central Region currently consists of the following locations: Galter 21, Galter 17, Galter- LC, Prentice LC, Prentice 4, Prentice 5, Prentice 14, Prentice, 15, Prentice 16, Olson 1, Arkes 12, Arkes 21, and Lavin 14. This position is responsible for administration including data analysis, problem solving, business planning and project management supporting clinical trials operations.

Responsibilities

• Accomplishes Clinical Operating goal setting, strategic planning and policy development reflecting sound clinical and business analyses including the assessment of clinical trial operational feasibility in the central region.
• Identifies and recommends CTO process improvements based on trial data and audits, with feedback from Program Directors, Senior Administration, as well as Medical School and Hospital Departments engaged in cancer clinical research involving the CTO
• Oversee central region clinical trials operations. Establish and manage progress against a set of clinical, service and financial outcomes that reflect optimal performance and are consistent with corporate standards and expectations. Practice continuous quality improvement. Maintain compliance with regulatory requirements. Ensure a functional and safe patient care trials environment.
• Ensures practices and performance management that contribute to high satisfaction among CTO faculty users and high employee engagement scores of CTO staff
• Responsible for Clinical trial feasibility review
• Oversees budget development for clinical trials and may assist with overall monitoring of resources and volumes of trials office operating budget. Assists unit leadership to provide high quality, efficient and cost-effective financial and administrative direction for the CTO and the overall cancer clinical research enterprise.
• Oversees the timely completion of patient specific billing to ensure hospital requirements for billing compliance is met
• Demonstrates knowledge and responsibility for processes related to CTO budgeting, cost containment, and process improvement
• Understands and assures compliance with all NCI CCSG guidelines and mandates related to the conduct of cancer clinical research in the CTO.
• Responsible for review and submission of all deviations as well as oversight of all corrective and preventative action plans while developing data tracking dashboards to focus improvement efforts on critical areas. Assess patterns and trends and recommend appropriate action
• Ensures frequent and optimal collaboration with Department users of the CTO (Internal Medicine, Radiation Oncology, Pediatrics, etc)
• Complex technical leadership and collaboration with faculty across 14 disease teams in determining oncology research trial priorities
• Responsible for oversight of clinical trial patient safety through protocol compliance
• Trouble-shoots emergent patient care issues with clinical teams to ensure adherence to protocol guidelines, institutional reporting policies, and federal regulations
• Oversees clinical audit readiness
• Develops clinical operations SOPs
• Develops communication, training, and clinical research education for all clinical departments (Including PIs, APNs, Infusion Nurses, IR Techs, etc..).
• Creates compliance tracking dashboards to ensure trial standards are met.
• Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives.
• PARTNERS WITH INTERNAL/EXTERNAL PROJECT AND IT STAFF TO CREATE, REVIEW, ANALYZE, INTERPRET, SUMMARIZE AND PREPARE PROGRESS & FINAL REPORTS
• REPRESENTS CLINICAL/PROFESSIONAL DISCIPLINE IN VARIOUS FORUMS OR COMMITTEES AND CONTRIBUTES TO THE ESTABLISHMENT OF ONCOLOGY CLINICAL TRIALS PROTOCOLS AND STANDARDS
• CONTRIBUTES TO ABSTRACT AND PUBLICATIONS FOR PROFESSIONAL CLINICAL RESEARCH SOCIETIES.

Qualifications

• Bachelor’s Degree required, masters preferred
• Certification in clinical research required (regulatory, coordinator, QA, or equivalent)
• 5+ years in clinical trials management required
• 10+ years’ experience in clinical trials conduct at NCI-designated cancer center
• Experience managing >25 staff required
• Experience managing in matrixed cancer center required (University and Healthcare system separate organizations)
• Experience with a successful Cancer Center Support Grant (CCSG) renewal

Competencies

• Communication: Excellent communication skills, keeping others informed, and balancing talking and listening
• Quality: Track record of continuous process improvement and quality control, identifies and leads process improvement projects as needed
• Patient Experience: Mindset of putting patients first, striving for high patient satisfaction, and engages the patients when appropriate and necessary
• Staff Engagement: Staff engagement is a clear priority, with clear expectations set, ongoing progress review, regular feedback and guidance, and holding staff accountable
• Leadership: Role model for other leaders, helpful, respectful, transparent, approachable and team oriented, work on building relationships with colleagues and supports and creates positive working environment
• Time Management: Good time manager, plans ahead, cost conscious, thinks of better ways to do things, takes ownership, follows through, and is doing what is needed without being asked
• Coachability: Willing to learn, self-reflective, receptive to feedback, embraces lifelong learning and improvement
• Clinical Trials: is able to run any cancer trial in any cancer type, can interact with all types of cancer trials sponsors, has experience preparing for successful audits, knows how to support compassionate use and expanded access protocols
• Oncology Faculty: understands the epidemiology and etiology of common cancer types, can interact with various MDs and their extenders, can partner with faculty to achieve goals
• Healthcare System: can work with clinical operational leadership in the inpatient and outpatient setting, supports the annual goals set forth by the health system, and engages in quality projects

Benefits

At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, visit us at https://www.northwestern.edu/hr/benefits/index.html.

Work-Life and Wellness

Northwestern offers comprehensive programs and services to help you and your family navigate life’s challenges and opportunities and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development

Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you’re interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.