JD #

JD00569

Pay Grade:

7

Title:

Clinical Research Assistant (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 Assistant to schedule and assist with clinical study visits with participants at the McMaster University Medical Centre.

This position is for an experienced clinical research assistant who will provide support 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:

Responsible for organizing and administering one or more clinical research projects within required deadlines under the direction of a Principal Investigator or project leader.

Purpose and Key Functions:

• Oversee the collection, entry, verification, management, analysis, and reporting of data.
• Use statistical software to analyze data and interpret results.
• Design and maintain databases, data collection forms, error checking methods and related programs for efficient collection, analysis, and reporting.
• Modify and reconfigure databases to ensure the optimal storage of data and minimize data entry complexities.
• Troubleshoot moderately complex computer problems.
• Write data management and operations documentation for the project.
• Liaise between the centre and remote clinic sites and personnel.
• Conduct structured patient interviews.
• Ensure that the relevant research methodology is applied and all research material is handled in accordance with established protocols, policies, and procedures.
• Participate in the development of promotional strategies and related materials to encourage participation and support for research projects.
• Develop presentations and present information and training sessions to project personnel and patients.
• Keep project participants informed of project progress through regular reports and newsletters.
• Gather and compile information and data required for the preparation of scientific papers, abstracts, and graphs.
• Conduct literature searches.
• Oversee the extraction and compilation of data required for reports and disseminate data to research groups and collaborating partners.
• Implement and maintain the research project budget. Create financial projections and make adjustments to the research project budget throughout the fiscal year.
• Exercise appropriate budget controls, monitor, and reconcile accounts.
• Write a variety of letters and memos.
• Participate in research project meetings and propose recommendations for procedure modifications and development in the areas of data management, quality control, and assurance.
• Write, update, and archive data management and quality assurance conventions.
• Respond to inquiries received from project personnel regarding relevant project issues and procedures.

Requirements:

• Bachelor's degree in a relevant field of study.
• Requires 2 years of relevant experience.

Assets:

For Department use only.

The candidate must have strong communication and organization skills, a demonstrated understanding of Good Clinical Practices (GCP) and the ability to ensure GCP are implemented and followed, experience working with patients/trial participants in a clinical research setting, and skills to perform blood draws. Experience with performing spirometry, submitting expense claims at McMaster and/or REDCap software are considered assets.

Additional Information:

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