Augusta University · 5 hours ago
Clinical Trials Manager- Clinical Trials Office
Augusta, GA
Full-time
Onsite
Senior Level
$83K/yr - $83K/yr
5+ years expAugusta University is Georgia's innovation center for education and health care, training the next generation of innovators and healthcare providers. The Clinical Trials Manager will provide advanced support and supervision to research staff, lead clinical research operations, and implement processes to improve efficiency and grow the clinical research program.
Higher Education
Responsibilities
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
Perform all other job-related duties as assigned
Qualification
Required
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
Preferred
Active Georgia Licensure as a Registered Nurse in good standing
Certified Clinical Research Coordinator (CCRC) or another clinical research certification
Benefits
Health insurance
Dental insurance
Life insurance
Teachers Retirement System (or Optional Retirement Plan)
Earned vacation time
Sick leave
13 paid holidays
Tuition Assistance Program
Company
Augusta University
Augusta University offers opportunities #LikeNoOther through groundbreaking research, patient-centered clinical expertise and forward-thinking educational programs from three campuses in the beautiful Southern city of Augusta, Georgia, and satellite locations across the state.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Stephen Wertz
Vice President for Foundations & CEO, Augusta University Foundation, Inc.
Heather Roszkowski, DSc
A/VP of Cyber Defense & Enterprise Chief Information Security Officer
Recent News
http://www.zdnet.com/
2024-04-30
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