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.
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.
Bachelor's degree in Nursing from an accredited college or university and current, active Georgia Licensure as a Registered Nurse in good standing.
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.
Knowledge, Skills, & Abilities
Ability to maintain confidentiality and work independently
Excellent interpersonal, written and verbal communication skills
Proficient in Microsoft Office and other computer software/databases
Detail-oriented with strong organizational, customer service and prioritization skills
Must be able to identify team inefficiencies, study concerns and provide assistance in problems solving
Must be able to clearly and effectively make decisions as they relate to personnel assignment, study management and other related matters
Preferred Certified Clinical Research Coordinator (CCRC) or equivalent.
Additional Salary Information: Based on Education and Experience