"Clinical Research Operations Director-GCC"

Job Summary

The Director Clinical Research Operations is responsible for defining the clinical research strategy for Georgia Cancer Center-Augusta University, aligning research operations with the strategy, vision, and mission of the organization. The Director is responsible for ensuring the clinical research infrastructure provides efficient, compliant, and customer service-oriented support to meet the needs of the research community.

The Director will work to create a culture of collaboration and financial sustainability to attract sponsors and external collaborators. The Director works cooperatively with administration and physician and faculty leadership, maintaining open communication with respect to clinical research strategy and infrastructure support.

The Director provides strategic direction for all activities associated with clinical research programs and services provided centrally, as well as providing oversight for all clinical research activities provided locally, to ensure that clinical research is conducted in compliance with all applicable laws, regulations, and institutional policies. The Director sets direction for developing and implementing unified policies, procedures, and education and training for investigators and staff conducting clinical research.

Responsibilities

The responsibilities include, but are not limited to:

STRATEGIC PLANNING

• Responsible for the overall strategic direction of research operations with an overall aim of establishing best-in-class clinical research infrastructure and operations
• Assists in institutional and new business development (e.g., increased utilization of research services, recruitment of pharmaceutical sponsored studies, improved capabilities to enhance NIH awards)
• Promotes customer service through the development and implementation of programs and quality standards
• Defines goals and objectives related to clinical research administration. Directs the development of metrics and reports to demonstrate achievement of identified goals. Submits quarterly reports to the leadership team
• Contributes to planning and development of infrastructure support to meet strategic goals
• Collaborates with other research administration, ancillary, and support departments and participates in institutional initiatives to enhance overall research operations across the research enterprise.

PROFESSIONAL DEVELOPMENT

• Oversees staff and evaluates performance against communicated expectations and competencies; mentors, coaches, counsels, and disciplines staff; develops professional growth opportunities
• Develops and applies a competency framework for research staff aligned to a clear professional ladder
• Develops and enforces quality and productivity standards through use of performance metrics, compliance with policies and procedures, and use of systems
• Maintains staff by recruiting, selecting, and onboarding employees
• Oversees development and deployment of training and education opportunities for the clinical research community
• Serves as the liaison with Human Resources in all staff related issues, including recruitment, retention, and professional development opportunities.

OPERATIONS

• Provides fiscal management oversight for research activities across the research portfolio. Monitors monthly utilization and budgetary allocations; assesses resource needs based on utilization analysis and projections
• Implements and enforces use of policies and procedures to ensure consistent and quality conduct of research.
• Ensures IT systems are utilized to maximize efficiencies, including targeting opportunities to integrate systems; oversees implementations and integrations of systems for clinical research administration
• Serves as an expert resource to researchers for research processes and exhibits sound problem-solving skills
• Applies expert knowledge of regulatory requirements (ICH, FDA, GCP, institutional and departmental, etc.) to research operations
• Coordinates with investigators to ensure timely, high quality customer service and compliance with internal policies and external regulatory agencies
• Holds research staff accountable for maintaining internal controls, accuracy, policy compliance, and high-level interpersonal service

PROCESS IMPROVEMENT AND QUALITY ASSURANCE

• Implements and ensures efficient processes for research activities. Monitors effectiveness and fiscal integrity
• Provides strategic leadership and ensures alignment of policies and procedures to technology systems
• Oversees quality assurance activities across clinical research operations
• Systematically measures collected data and uses data, quality assurance, and customer feedback as part of continuous process improvement; designs, plans and delegates new initiatives
• Oversees the development, implementation, and updating of SOPs to ensure consistent, safe and efficient management of clinical trials and continuous improvement.
• Represents the GCC on Institutional committees and task forces. Serves as liaison to advance clinical trial interests.
• Performs other duties as assigned.

Required Qualifications

Educational Requirements

Advanced degree from an accredited college or university in a related discipline (MHA, MBA, MSN).

Required Experience

Ten years of progressive management experience in clinical research operations.

Knowledge, Skills, & Abilities

SKILLS:

• Demonstrated organization, leadership, and management skills, including change leadership that enables self and others to align to, plan for, lead through, and embrace changes.
• Strategic thinking and entrepreneurial spirit that anticipates the impact of technological, social, and economic trends on the institution and the role of the research enterprise in a major teaching hospital and university setting.
• Effective interpersonal and communication skills with the ability to effectively lead and manage a team and engage resources in a complex, decentralized environment.
• Record of accomplishment working with faculty and institutional administration.
• Excellent problem-solving skills, including creativity, resourcefulness, timeliness, and technical knowledge related to analyzing and resolving financial, compliance, and/or institutional challenges impacting clinical research.

Shift/Salary/Benefits

Shift: Days/M-F (work outside of the normal business hours will likely be required of an employee in an exempt level position)

Pay Band: B18

Salary Minimum: $125,900/annually

Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position

Recruitment Period: 4/2/25 - Until Filled