About This Role
This Nurse Manager role involves providing leadership, guidance, support, and training to the clinical (Safety Team) members, and coordinating operational activities of research studies within the department. The Nurse Manager leads and directly supervises a team of clinical staff and is responsible for their clinical activities and performance. The role reports to the Director, Clinical Operations, and provides insight and assistance with internal department budgets, planning, and other clinical/administrative activities.
Responsibilities
- Ensure general clinical duties are performed to prepare for clinical studies and proper monitoring of clinical activities
- Oversee the execution of clinical trials, coordinating all study clinic activities to ensure all clinic needs are met (tasks, subject safety, work schedules, breaks, clinic set-up, etc.)
- Work collectively with the Director, Clinical Operations, Chief Medical Officer, and Manager, Clinical Operations as required
- Analyze and develop action plans to address issues with study monitors, sponsors, and regulatory agencies
- Organize, oversee, and conduct Safety Team staff training, performance reviews, and coaching
- Work with the Director, Clinical Operations to assist in evaluating HR requirements within the department
- Ensure clinical trial activities are conducted in accordance with the Protocol, SOP, ICH, GCP, and applicable regulatory requirements
- Ensure the accuracy of generated data in accordance with protocols, SOP, ICH, GCP, and applicable regulatory agencies
- Write, revise, and approve SOPs and internal procedures
- Participate in protocol review and development
- Participate in project scheduling, assessing, and establishing project milestones
- Review and/or approve the Safety Team staff schedule and task assignments
- Assist Director, Clinical Operations, and the Chief Medical Officer with day-to-day activities
- Lead, train, and coach the team to ensure proper planning, organization, and execution of clinical research studies
- Participate in strategic decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget
- Participate on Safety Committee, Protocol Review Committee, and inter-departmental meetings as required
- Actively analyze and develop action plans to address issues brought up by QA, QC, Study Monitors, sponsors, and regulatory agencies
Requirements
- RN, Nurse in good standing with appropriate college or regulatory body
- Knowledge of Good Clinical Practice
- Updated CPR and ACLS Certification
- Able to work in a research setting and aware of the confidentiality that is required in research
