Nurse Manager

CYBERWELL Solutions; Toronto; On-site; CAD 90,000 - 120,000; Full time

Job summary

CYBERWELL Solutions seeks a Nurse Manager to lead the clinical operations and Safety Team within our research department. You will guide staff, coordinate trial activities, and ensure adherence to protocol, SOP, ICH, and regulatory standards.

You will report to the Director, Clinical Operations, and contribute to budgets, planning, and day-to-day clinical operations. Requires RN licensure and 5+ years in clinical research.

Qualifications

• RN 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 confidentiality requirements in research.
• At least 5 years’ experience in clinical research or related field.
• Computer literacy: MS Office, good communication skills, problem solving, organizational and leadership skills.

Responsibilities

• Lead and supervise the Safety Team and clinical staff, guiding activities and performance.
• Coordinate clinical trial operations, study clinic activities, and schedules.
• Collaborate with Director, Chief Medical Officer and managers on operational planning.
• Analyze issues with monitors, sponsors, and regulatory agencies; develop action plans.
• Organize Safety Team training, performance reviews, and coaching.
• Assist with HR requirements and resource planning within the department.
• Ensure trials comply with Protocol, SOP, ICH, GCP and regulatory requirements.
• Verify data accuracy and approve SOPs and internal procedures.
• Participate in protocol review, project scheduling, and milestone setting.
• Lead planning and execution of clinical research studies.

Skills

GCP knowledge

CPR certification

ACLS certification

confidentiality awareness

leadership

communication

problem solving

organization

Education

RN license

Tools

MS Office

Job description

The Nurse Manager is responsible for providing leadership, guidance, support, and training to the clinical (Safety Team) members, and to coordinate operational activities of research studies within the department. The Nurse Manager leads and directly supervises a team of clinical staff, such as RNs, RPNs, Paramedics, and Medical Assistants, and is responsible for the team’s clinical related activities, and performance. The Nurse Manager will report to the Director, Clinical Operations, and will provide insight and assistance with internal department budgets, planning, and other clinical/administrative activities as required.

Duties and Responsibilities:

• Ensure the general clinical duties are performed to prepare for the clinical study and proper monitoring of clinical activities.
• Oversees 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.
• Ensures the accuracy of the generated data in accordance with protocols, SOP, ICH, GCP and applicable regulatory agencies.
• Write, Revise, and approve SOP’s and internal procedures.
• Participates in protocol review and development.
• Participates 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.
• Participates in strategic decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget.
• Participates on Safety Committee, Protocol Review Committee, 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.

Qualifications:

• 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
• At least 5 years’ experience in clinical research or related field
• Computer literacy: MS Office, good communication skills, problem solving, organizational and leadership skills