The Clinical Research Assistant will support the coordination and execution of one or more clinical research projects, working closely with Principal Investigators, statisticians, and the broader research team. This role involves a blend of data management, statistical analysis, and administrative responsibilities. The successful candidate will contribute to the development of study materials, regulatory submissions, and grant applications, while ensuring high standards in data quality and compliance. Proficiency in statistical software (e.g., SPSS) and strong communication skills are essential, as the role requires collaboration across multiple sites and disciplines. On-site presence is required.
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.
Job Type: Full-time
Pay: $58,000.00-$60,000.00 per year
Benefits:
Dental care
Disability insurance
Extended health care
Life insurance
Paid time off
Vision care
Education:
Bachelor's Degree (preferred)
Experience:
clinical research and statistician : 2 years (required)
Work Location: In person
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