Clinical Trials Manager- Clinical Trials Office

* 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 12,000 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 https://(Use the "Apply for this Job" box below). 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 https:// 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 https://.

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

Location

Augusta University

Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912

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

College/Department Information

Augusta University is actively participating in ways to improve the health and lives of the people of our community, our state, and around the world. To do this, we conduct research, a great deal of which is done through clinical trials in humans (known as human subject research). There are many federal requirements that all research institutions must meet to conduct human subject research.

We have an outstanding, dynamic, and growing group of researchers, administrators, and office staff ready to assist. Our defined strengths lie in the areas of:
Conventional clinical trials, community and population health, social, behavioral, and educational research. Community education, well-defined research initiation process, ongoing and continued support for conduct of research, and integrated and technology advanced IT systems to support efficient research processes.

Job Summary

The Clinical Trials Manager provides advanced level of professional support and supervision to research staff within the Clinical Trials Office (CTO). This individual will be directly responsible to work with senior research leadership and administrators to implement processes and initiatives that will improve efficiency, fiscal soundness, and to grow the clinical research program.

As a key member of the CTO leadership team, they will lead clinical research operations, be responsible for monitoring workloads to include determining appropriate staffing levels. This individual will take the lead in the development and execution of CTO training/mentoring programs to include quality improvement processes.

Responsibilities

Responsibilities to include, but are not limited to:

Responsible for the direct supervision of clinical research staff that includes monitoring workloads, performing annual staff evaluations, determining appropriate staffing levels for the clinical research staff (nurse clinicians, research associates/assistants and data coordinators) and recommendations to hire/terminate employees. Quality assessment of work performed by team members, including adherence to protocols, regulatory compliance, meeting deadlines, timeliness and accuracy of CRF completion, and adherence to AU and CTO policies and guidelines.

Leads the daily clinical research operations for one or more key areas. Study design:
Oversee protocol development and collection of central documents. Clinical research services:
Recruitment of new study participants, study management, regulatory and data management, assist with unfunded and/or investigator-initiated studies. Monitoring:
Attend and/or monitor Pre-site visit (PSV), Site initiation visit (SIV), and Monitoring visit (MV), and assist with audit preparation as needed.

Assist with developmental, revision, and continuous evaluation of clinical research department standards and policies. Participate in…