Clinical Trials Manager - Clinical Trials Office

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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: 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 in order 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, population health, social, behavioral, and educational research; Community education; Well-defined research initiation process; Ongoing and continued support for conduct of research; 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:

SUPERVISION: 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.

CLINICAL RESEARCH: 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, data management, assist with unfunded and/or investigator-initiated studies. Monitoring: Attend and/or monitor Pre-site visit (PSV), Site initiation visit (SIV), Monitoring visit (MV), as needed assist with audit preparation.

QUALITY IMPROVEMENT: Assist with developmental, revision, and continuous evaluation of clinical research department standards and policies; participate in and/or lead process improvement working groups and staff mentoring educational activities. Develop and execute training/mentoring programs, quality improvement processes, the development of Internal Guidance Documents and other projects as assigned. Working collaboratively with other research teams, create and administer a continuous quality improvement program for CTO.

FINANCIAL MANAGEMENT: Work in collaboration with the Regulatory and Financial team to assist with the development of addressing study balances and working on a solution to address those that are running in the negative. In collaboration with the primary coordinator, Research Development Services, and Clinical Translational Finance Manager, complete study financial startup (development of the comprehensive clinical trials electronic billing grid, budget related to per patient costs, etc.). Work with PIs to assist in study design; estimates of time/effort required for study visits, procedures, CRF completion, and data entry into sponsor data portals; budget development; study feasibility.

MISCELLANEOUS: Actively participate in operational review of new protocols and amendments for feasibility of conduct.

OTHER: Perform all other related duties/tasks as assigned.

Required Qualifications

Bachelor's degree in Chemistry, Biology, Biochemistry, Cell Biology or other natural healthcare or material science from an accredited college or university and a minimum of five years' experience in executing multidisciplinary clinical research protocols and a minimum of two years' supervisory/management experience.
OR
Bachelor's degree in Nursing from an accredited college or university and current, active Georgia Licensure as a Registered Nurse in good standing.
OR
Associate's degree in Nursing from an accredited college or university and current, active Georgia Licensure as a Registered Nurse in good standing and a minimum of eight years' related clinical and/or management experience.

Preferred Qualifications

Preferred Certified Clinical Research Coordinator (CCRC) or equivalent

Knowledge, Skills, & Abilities

KNOWLEDGE

Proficient in Microsoft Office and other computer software/databases.

SKILLS

Excellent interpersonal, written, and verbal communication skills.

Detail-oriented with strong organizational, customer service and prioritization skills.

ABILITIES

Ability to maintain confidentiality and work independently.

Must be able to identify team inefficiencies, study concerns and provide assistance in problem solving.

Must be able to clearly and effectively make decisions as they relate to personnel assignment, study management and other related matters.

Shift/Salary/Benefits

Shift: Days; Monday - Friday (Work outside of normal business hours may be required).

Salary Range: $82,800-$83,000 annually.

Pay Band: B15

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

Recruitment Period: Until Filled.

Augusta University offers a variety of benefits to full-time benefits-eligible employees and some of our half-time (or more) employees.

Benefits that may be elected could include health insurance, dental insurance, life insurance, Teachers Retirement System (or Optional Retirement Plan), as well as earned vacation time, sick leave, and 13 paid holidays.

Also, our full-time employees who have been employed with us successfully for more than 6 months can be considered for the Tuition Assistance Program. Consider applying with us today!

Conditions of Employment

All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University.

If applicable for the specific position based on the duties: the candidate will also need to have a credit check completed for Positions of Trust and or approved departmental Purchase Card usage.

Motor vehicle reports are required for positions that are required to drive an Augusta University vehicle.

For Faculty Hires: Final candidates will be required to provide proof of completed academic degree(s) as well as post-secondary coursework in the form of original transcript(s). Those candidates trained by a foreign institution will also be required to provide an educational/credential evaluation.

All employees are responsible for ensuring the confidentiality, availability, and integrity of sensitive [patient, student, employee, financial, business, etc.] information by exercising sound judgment and adhering to cybersecurity and privacy policies during their employment and beyond.

Other Information

This position is also responsible for promoting a customer-friendly environment and providing superior service to our patients, students, faculty, and employees. "Augusta University is a patient-and family-centered care institution, where employees partner every day with patients and families for success."

Augusta University is a tobacco-free environment, and the use of any tobacco products on any part of the campus, both inside and outside, is strictly prohibited.

Equal Employment Opportunity

Augusta University is proud to be an equal opportunity employer, welcoming applicants from underrepresented groups, including individuals with disabilities and veterans.

How To Apply

Consider applying with us today!

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