Clinical Research Assistant

Representative Duties & Responsibilities

• Support the development of research study materials, including protocols, patient information documents, and case report forms, with attention to data collection and statistical considerations.
• Assist in the preparation of regulatory submissions (e.g., REB, Health Canada), ensuring data and statistical elements are accurately presented in collaboration with subject matter experts.
• Contribute to grant applications and revisions by compiling relevant data and supporting statistical documentation in coordination with the statistician.
• Utilize SPSS or equivalent statistical software to perform preliminary data analysis and generate descriptive statistics; collaborate with a statistician for advanced statistical modeling and interpretation.
• Prepare materials for key meetings, including progress reports and data summaries, with input from statistical consultants as needed.
• Design and maintain databases, data collection forms, and error-checking procedures to ensure high-quality data for analysis and reporting.
• Act as a liaison between the central project team and remote sites, ensuring consistent data collection practices and adherence to study protocols.
• Ensure appropriate research methodologies are applied and that all research materials are managed in compliance with established protocols, policies, and regulatory standards.
• Develop and deliver presentations and training sessions for project personnel and participants, including updates on data collection and preliminary findings.
• Compile and organize data for scientific papers, abstracts, and visualizations; work with statisticians to ensure accuracy and clarity of statistical content.
• Conduct literature reviews and Freedom to Operate searches, including identifying relevant statistical approaches used in similar studies.
• Oversee data extraction and compilation for reporting purposes, coordinating with statisticians and research collaborators to ensure data integrity.
• Respond to project-related inquiries, providing guidance on data collection procedures and liaising with statisticians for complex statistical questions.
• Perform administrative tasks as required, including documentation and coordination of research activities.
• Adhere to Good Clinical Practice (GCP) guidelines and other applicable standards in data handling and reporting.
• Collaborate effectively with a diverse range of researchers and stakeholders across multiple projects, contributing statistical insight and coordination.

General Description

Responsible for coordinating and supporting one or more clinical research projects, including data management and statistical analysis, under the direction of a Principal Investigator or project lead. Works closely with a statistician for advanced analytical tasks. On-site presence is required.

Qualifications

• Bachelor’s degree in Health Sciences, Epidemiology, or a related field.
• Minimum of 2 years of experience in clinical research, including hands-on experience with statistical software.
• Proficient in SPSS or equivalent statistical tools for data management and basic analysis.
• Skilled in MS Word, Excel, and PowerPoint, with experience in preparing data-driven reports and presentations.
• Demonstrated discretion in handling sensitive and confidential information.
• Strong initiative and ability to work independently while knowing when to seek expert input.
• Effective team collaborator with excellent organizational and time management skills.
• Capable of independent judgment in routine tasks and coordination of statistical workflows.
• Strong interpersonal and communication skills, especially in working with statisticians and translating data insights to non-technical audiences.
• Ability to write original content for reports, grants, and descriptive documents, incorporating statistical findings with support from statistical experts.