Job Description:

The Clinical Trials Resource Nurse participates in the planning, coordination and the implementation of clinical trials from protocol review and approval through to activation, follow-up and trial closure. Major responsibilities include protocol review, ethics submissions, start-up procedures, patient screening and assessment for eligibility, registration of patients to protocols, collection and submission of data, monitoring of study compliance, monitoring of patients on clinical trials, toxicity assessment and intervention. Provides necessary assistance to educate Cancer Care Program staff and other key stakeholders about each clinical trial, including but not limited to: inclusion and exclusion criteria and assessment of patient pre and post study.

Education:

• Registered Nurse with current Certificate of Competence required
• CNA Certification in Oncology required or obtained within 2 years of hire required
• DeSouza Foundations in Oncology Nursing Practice required
• DeSouza Provincial Standardized Chemotherapy and Biotherapy Course preferred
• CANO/ONS membership preferred
• Certification and/or Education from a relevant Research Program (SOCRA, ACRP) preferred
• Current CPR registration required

Experience:

• Minimum 5 years recent oncology nursing experience in the inpatient or ambulatory care setting required
• Clinical trials experience required

Competencies:

• Knowledge of regulatory issues involving human subjects
• Demonstrated relevant clinical research skills
• Demonstrates excellent written and verbal communication skills, excellent organizational and prioritization skills
• Excellent computer skills (MS Office, Word, Excel, Powerpoint)
• Ability to learn quickly and work independently
• Excellent interpersonal skills
• Demonstrates critical thinking skills and the ability to work in a fast paced environment with changing priorities
• Demonstrates interest and commitment to professional growth of self and others
• Demonstrates an interest in maintaining a high standard of patient care

Responsibilities:

• Participates in the planning, coordination and the implementation of clinical trials from protocol review and approval through to activation, follow-up and trial closure
• Protocol review, start-up procedures, patient screening and assessment for eligibility, registration of patients to protocols, collection and submission of data, monitoring of study compliance, monitoring of patients on clinical trials, toxicity assessment and intervention
• Contributes oncology research subject matter expertise to the planning and execution of study start-up processes including: study budget negotiation, contracts, CDA, study feasibility and Departmental impacts
• Review pre-trial site metrics and lead study risk planning process for site identification and feasibility
• Act as a liaison between study subjects, physician investigators, primary care providers, protocol sponsors, as well as any other stakeholders
• Collaborate with the clinical trials team to update them on trial activity, including without limitation, enrollment, adverse events and site queries
• Educate key stakeholders about each clinical trial, including but not limited to: inclusion and exclusion criteria and assessment of patient pre and post study
• Ensures scientific integrity of data and protect the rights, safety, and wellbeing of patients enrolled in clinical trials
• Liaises with study team members to ensure high standards of quality and optimal management of research participant care
• Collaborates with investigators and health care team to assume responsibility for the overall patient management and co-ordination of clinical trials studies
• Execution of all aspects of patient visit (assessment adverse events, monitoring safety, medication, questionnaires, sample collection, including processing and shipment of samples according to clinical protocol, chemotherapy administration)
• Trains and mentors clinical research staff