Clinical Trials Manager- Clinical Trials Office

Clinical Trials Manager - Clinical Trials Office

Job  |

Location:

Augusta University | Full/Part Time:
Full Time

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 make Augusta University an institution like no other.

The Clinical Trials Manager provides an 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.

• 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 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.
• 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, and study feasibility.
• Actively participate in operational review of new protocols and amendments for feasibility of conduct.

• Master's degree in Chemistry, Biology, Biochemistry, Cell Biology or other natural, life, health care, or materials science from an accredited college or university with at least three years of experience in executing multidisciplinary clinical research protocols, including two years of supervisory/management experience.
• OR
• Bachelor's degree in Chemistry, Biology, Biochemistry, Cell Biology or other natural, life, health care, or materials science from an accredited college or university with at least five years of experience in executing multidisciplinary clinical research protocols, including two years' supervisory/management experience.

• Active Georgia Licensure as a Registered Nurse in good standing.
• Certified Clinical Research Coordinator (CCRC) or another clinical research certification.

• Proficient in Microsoft Office and other computer software/databases.
• Excellent interpersonal, written, and verbal communication skills.
• Detail-oriented with strong…