Clinical Trials Manager - Job Opening 223664
Augusta University

Clinical Trials Manager - Job Opening 223664

How to Apply:

To be considered an applicant for this position, you must apply online at https://www.augusta.edu/jobs and search Job ID: 223664.

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.

Job Summary

The Clinical Trials Manager provides advanced level 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.

The duties 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 Duties: Perform all other related duties/tasks as assigned.

Shift/Salary

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

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

Recruitment Period: Until Filled

Conditions of Employment

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

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 the course of their employment and beyond.

Equal Employment Opportunity

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

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 everyday 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.