Clinical Trials Manager- Clinical Trials Office

Overview

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.

• Direct supervision of clinical research staff, including monitoring workloads, performing annual staff evaluations, and determining appropriate staffing levels for nurse clinicians, research associates/assistants, and data coordinators.
• 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.
• Lead daily clinical research operations for one or more key areas. Oversee study design, protocol development, and collection of central documents.
• Clinical research services: recruitment of new study participants, study management, regulatory and data management, and support for unfunded/investigator-initiated studies.
• Monitoring: attend/monitor Pre-site visit (PSV), Site initiation visit (SIV), Monitoring visit (MV); assist with audit preparation as needed.
• Assist with development and continuous evaluation of clinical research department standards and policies; participate in/process improvement working groups and staff mentoring educational activities.
• Develop and execute training/mentoring programs, quality improvement processes, internal guidance documents, and other projects; collaborate to create and administer a continuous quality improvement program for CTO.
• Work with Regulatory and Financial teams to address study balances and develop solutions for negative balances; assist with study startup including budgeting, per-patient costs, and data entry into sponsor portals.
• Collaborate with PIs on study design, time/effort estimates for visits and procedures, CRF completion, and feasibility assessments.
• 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 organizational, customer service, and prioritization skills.
• Ability to maintain confidentiality and work independently.
• Ability to identify team inefficiencies, study concerns, and provide assistance with problem solving.
• Ability to clearly and effectively make decisions as they relate to personnel assignments, study management, and other related matters.

• Shift: Days;
  Monday - Friday (Work outside of normal business hours may be required).
• Salary: $82,800-$83,000 annually.
• Pay Band: B15.
• Salary to be commensurate with qualifications within the established range.
• This position is…