JD #

JD00647

Pay Grade:

10

Title:

Clinical Research Nurse (I)

Unit/Project Description:

For Department use only.

The AeroVax trial is a Phase 2, double-blind, placebo controlled clinical trial to evaluate the safety and immunogenicity of an aerosol inhaled COVID vaccine developed at McMaster University. The AeroVax trial is seeking a full-time Clinical Research Nurse to conduct clinical study visits with participants at the McMaster University Medical Centre.

This position is for an experienced Clinical Research Nurse who will have overall responsibility for participant visits in a Phase 2 clinical trial of a first-in-class inhaled COVID vaccine. This is a unique opportunity to be part of the Mucosal Immunology Vaccine Research team at McMaster University which has successfully implemented Phase 1 clinical trials of inhaled tuberculosis and COVID-19 vaccines. This team includes clinicians, research scientists/immunologists and trainees and is led by Dr. Fiona Smaill.

Job Summary:

The Clinical Research Nurse (I) is responsible for planning, assessing, implementing, and evaluating protocol procedures and managing the daily operations of clinical research studies ensuring that all aspects of the study protocol are adhered to. Coordinates all aspects of the project related to managing a patient from study entry to completion of a follow-up which includes coordinating other aspects of on-going care. Requires specialized, professional nursing care knowledge in the clinical area and knowledge of research principles and practices.

Purpose and Key Functions:

• Assume primary responsibility for the preparation and implementation of clinical research protocols.
• Participate with a team in the development and authoring of research protocols.
• Troubleshoot problems at all stages of project development and implementation and assist with modifying protocols or project procedures to address challenges.
• Interview patients and conduct physical and psychiatric assessments to determine eligibility for participation in research studies.
• Monitor patients for adverse reactions and be prepared to respond appropriately.
• Mediate with family members and caregivers who may be hesitant to have their family member involved in a study and educate them regarding the disease process and the benefits of clinical studies.
• Liaise between the clinic centre and remote clinic sites and personnel.
• Process information and have the knowledge base required to recognize problems with patients and intervene appropriately for the well being of the patient.
• Analyze and process information to ensure the accuracy and appropriateness of patient management.
• Ensure that the relevant research methodology is applied and all research material is handled in accordance with established protocols, policies, and procedures.
• Conduct and process study specific assessments of patients to determine suitability for projects and degree of disease acuity.
• Apply specialized knowledge and scientific principles to review, critically appraise and interpret published literature.
• Empathize with study patients and be attentive to their needs.
• Recruit patients and enlist agencies to refer patients.
• Review referrals and keep track of intakes from various referral sources.
• Design promotional strategies and related materials to encourage participation and support for the research study.
• Facilitate focus group sessions with study patients.
• Write sections of scientific papers, funding proposals, abstracts, and Research Ethics Board submissions.
• Design and develop various forms, data reports, and letters required for the study.
• Document and analyze patient responses and adverse events that may be experienced by a patient during the study.
• Document and maintain patient consult notes, assessments, drug accountability logs, charts, and histories on each patient.
• Plan and coordinate studies across multiple sites.
• Develop estimates of time and resources for research projects.
• Use statistical software to analyze data and interpret results.
• Complete various calculations such as medication doses, safety values for clinical testing, and drug formulas.
• Develop presentations and present information and training sessions to study personnel and patients.
• Retrieve and respond to results of diagnostic tests.
• Keep study participants informed of study progress through regular reports and newsletters.
• Implement and maintain study budgets. Create financial projections and make adjustments to study budgets throughout the fiscal year.
• Exercise appropriate controls, monitor, and reconcile accounts.
• Responsible for the accurate collection of relevant data and ensure that all events are identified and properly recorded and that necessary confidentiality is maintained.
• Collect, verify, evaluate, and record all patient study data.
• Update and maintain information in a variety of databases and spreadsheets.
• Gather, compile, and submit all pertinent documents such as physician and nursing licenses, curriculum vitae for all staff involved in the study, Food and Drug Administration forms, and Research Ethics Board documents, prior to the start of a clinical study.
• Arrange for the safe and orderly exit of patients from the study.
• Accountable to the College of Nurses of Ontario for all actions taken with study patients and must practice according to the Regulated Health Professions Act and the Standards of Practice for Nurses in Ontario.
• Conduct literature searches.
• May be required to perform specific medical procedures such as, venipuncture, pipetting samples, and administering medication by injection.
• May be required to set up and monitor various medical devices such as intravenous and electrocardiogram equipment.
• Collaborate with hospital administrators to facilitate the introduction of study protocol procedures within their departments.
• Coordinate the procurement of equipment, supplies and data collection forms.
• Inform patient and family about study protocols and procedures.
• Explain benefits, risks and schedules prior to obtaining informed consent. Obtain formal, informed, and signed consent.
• Abide by and adhere to hospital partners' policies and procedures with regards to various sources of information such as health records and databases.
• Maintain the confidentiality of patient files and study data.
• File and maintain a variety of documents such as source documentation, case report forms, and clinical records according to established regulations.

Requirements:

• Bachelor’s degree in Nursing.
• Requires 4 years of relevant experience.
• Must be registered and maintain annual registration with the College of Nurses of Ontario as a Registered Nurse.

Assets:

For Department use only.

The candidate will be a registered clinical nurse with a strong understanding of Good Clinical Practices (GCP) and demonstrated experience with implementing GCP in a clinical research setting. The candidate must be self-directed, with strong communication skills and be able to perform blood draws. The Clinical Research Nurse will be responsible for screening and consenting participants, completing Case Record Forms accurately, administering the aerosol vaccine, and performing blood draws. Experience with performing spirometry and/or REDCap software are considered assets.

Additional Information:

Schedule: Mon-Fri 8am-4pm with some flexibility.