Clinical Research Operations Director

Clinical Research Operations Director-GCC

Job ID: 283612
Location: Augusta University
Full/Part Time: Full Time
Regular/Temporary:

About Us

Augusta University is Georgia's innovation center for education and health care, training the next generation of innovators, leaders, and healthcare providers in classrooms and clinics on four campuses in Augusta and locations across the state. More than 10,500 students choose Augusta for educational opportunities at the center of Georgia's cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences. Augusta is home to Georgia's only public academic health center, where groundbreaking research is creating a healthier, more prosperous Georgia, and world-class clinicians are bringing the medicine of tomorrow to patient care today. Our mission and values make Augusta University an institution like no other.

Augusta University's distinct characteristics in education and research include real-world experiences and community engagement, as well as a culture of building community, corporate and government partnerships that address health, security, economic and societal concerns locally and across the state.

The University System of Georgia is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found online at

Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found online at .

Location

Augusta University

Our Health Sciences Campus: th Street, Augusta, GA 30912

Our Summerville Campus: 2500 Walton Way, Augusta, GA 30904

College/Department Information

The Georgia Cancer Center is on a mission for providing industry-leading cancer research and care that benefits patients locally and globally. Our ultimate goal is to eradicate cancer and we are proudly making progress every day. When we say patient care is a priority, we mean it. We assemble custom teams of field experts to address each individual's unique needs.

The research and innovations developed at the Georgia Cancer Center ultimately influence the global network of cancer care. Our team fights for far more than just Georgians. The learnings achieved through the care of local patients has wide-reaching implications for creating tomorrow's standard of cancer care. Through facilitating first-in-the-nation trials and growing a depth of understanding only available through a multidisciplinary approach, the Georgia Cancer Center team is equipped to deliver treatment advancements that will be applied in facilities across the world. The team offers a proving ground that paves the way for patients in other areas to have access to new options.

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 1he 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.
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