Director of Research Operations and Education

The Director of Research Operations and Education is responsible for overseeing the operations, workforce development, and strategic growth of a large, multidisciplinary research organization, including clinical research study operations and clinical research education programs. The Director provides leadership and oversight for more than 110 clinical research professionals supporting over 450 active clinical research studies and is responsible for the growth and maintenance of the organization's clinical research infrastructure.

The Director develops and oversees organizational strategy and goals, provides strategic leadership for research operations and education initiatives, and builds and models a high-performance culture through effective people management and career development of the clinical research workforce at Children's Colorado.

• Leads a multidisciplinary clinical research organization, partnering closely with both internal and external physicians and institutional leaders.
• Oversees sub-departments including but not limited to: clinical research coordination and services, regulatory affairs, financial operations, project management, contracting, general administrative services, clinical research management system, internal awards programs, research nurses, and laboratory testing.
• Supports investigator teams conducting research projects across the spectrum of sponsor types (e.g., governmental, non-profit, industry) and study types (both sponsor, and investigator initiated [including investigational drugs and devices]).
• Utilizes knowledge of federal regulations and the legal and regulatory environment governing academic and/or clinical research administration to guide the execution of high-quality, safe, efficient and effective clinical research, with a strong focus on customer service, regulatory compliance, transparency and commitment to programmatic excellence and ongoing evaluation.
• Facilitates support for intellectual property issues, e.g. technology transfer, licensing and commercialization issues in a non-profit, academic setting.
• Participates in organizational strategic planning, and provides leadership in defining and implementing mission, vision, values, goals and priorities and measuring and reporting on progress.
• Develops a high-performing management team and oversee recruitment, training, management and evaluation of all personnel, with a focus on building a high-performing, transparent and inclusive culture with strong employee engagement.
• Develops and oversees a department and organizational budgets and financial performance.
• Engages and collaborates with leaders across the organization, campus and partnering organizations to advance and improve clinical research operations.
• Works in partnership with other departments and divisions to oversee hospital-wide research feasibility and start-up process, ensuring that research conducted at the institution meets regulatory, financial and legal requirements.

EDUCATION - Bachelor's degree required

EXPERIENCE - Significant clinical research operations experience in hospital setting - 8 or more years of experience in a healthcare setting with 5 or more years of management experience; research/scientific experience highly preferred

• Previous Director level experience supporting research operations within a system of care.
• Previous leadership experience over a large, complex team of individuals.
• Strong knowledge of clinical research operations including: regulatory, pre/post award financial management, proposal submissions, contracts, Phase 1 trials.

CERTIFICATION(S) - Clinical research and Lean/Six Sigma certifications preferred

Pay is dependent on applicant's relevant experience.

Annual Salary Range (Based on 40 hours worked per week): $ to $

GUIDELINES: Guidelines are in the form of stated vision and objectives for the division. A second level manager directs and manages an operational and/or a functional area by developing objectives and strategies.

COMPLEXITY: Work assignment is unstructured and employee is responsible for implementing and managing a variety of objectives, resources, and strategies to achieve the goals of the division. Duties performed include operational and organizational planning, developing standards, schedules, priorities, guidelines, processes, measurement (evaluation) systems, implementation of production and performance management standards, and…