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Inside Higher Ed · 3 weeks ago

Clinical Research Operations Director-GCC

Augusta, GA

Full-time

Onsite

Director/Executive

10+ years exp

Augusta University is Georgia's innovation center for education and health care, training the next generation of innovators and healthcare providers. The Director of Clinical Research Operations is responsible for defining the clinical research strategy, ensuring compliance, and providing strategic direction for clinical research programs at the Georgia Cancer Center.

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Responsibilities

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

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

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

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 1he GCC on Institutional committees and task forces. Serves as liaison to advance clinical trial interests

Performs other duties as assigned

Qualification

Clinical research operationsStrategic planningRegulatory complianceFiscal managementInterpersonal skillsLeadership skillsProblem-solving skillsCommunication skills

Required

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

Ten years of progressive management experience in clinical research operations

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