Position: Clinical Research Data Associate
The Clinical Research Data Associate is responsible for the development and maintenance of all data-related aspects of clinical trial work, both for site-wide and project-specific requirements. The Data Associate works to incorporate efficiency and accuracy in the handling of data throughout the clinical trial process; this includes working on all aspects of the clinical data management plans prior to the trial start, as well as conducting secure storage and analysis of data after trial closeout.
- Primarily responsible for the implementation of data collection tools: CRF, eCRF and other source document development/maintenance.
- Responsible for performing data quality checking (completeness, correctness and consistency of data and data structures) during study conduct, in accordance to department SOPs.
- Perform time-sensitive duties associated with study initiation, including contributing to data management plans, setup documents and reports submitted to sponsors.
- Work with Clinical Trial Management Systems (CTMS) and/or Electronic Data Capture (EDC) platforms to perform data management tasks, including: eCRF modifications, data input, verification, discrepancy and query resolution, data extraction.
- Primarily responsible for performing verification procedures, including edit checks, data extraction and load procedures, using programming-based tools.
- Primarily responsible for the accurate maintenance of variable codelists and aCRF documents as well as their alignment to specifications in clinical trial protocols.
- Review data acquisition conventions and data review guidelines consistent with department SOPs, clinical data model, statistical analysis plans, and CRF (eCRF) completion.
- Assist in writing SOPs, interpreting clinical trial data and writing reports.
- Assist in analyzing and interpreting collected data using statistical, programming and visualization software.
- Continued education in regulatory guidelines, as well as Good Clinical Practices in Data Management (GCDMP) and continually contributing to the improvement of data management practices.
- Participate in protocol writing such as study design and statistical analysis plan, as required.
- Assist in statistical data analysis and reporting with SPSS software and/or other software.
- Ensure compliance with applicable research site SOP’s, and maintains familiarity with all Regulations, and applicable regulatory guidance informing the documentation, analysis of clinical trial data.
- Report directly to Clinical Data Scientist/Clinical Data Manager, as well as communicate with internal stakeholders for establishing and adhering to clinical trial project timelines.
- Perform other duties as assigned by management, and as delegated by Investigator.
- Minimum of a Bachelor’s degree with considerable exposure to quantitative and computing-related coursework, as well as 2+ years of experience working with data.
- Clinical research organization (CRO) experience; or, relevant industry-related clinical data management experience preferred.
- At least one of the following:
o GCP Certification
o Equivalent CRO industry experience
- Familiarity with ICH-GCP Guidelines and Regulations (Health Canada, FDA, and all other applicable bodies) as they pertain to clinical trials. Basic Knowledge of GCDMP practices an asset.
- Comfort in functional programming/scripting environments such as Python, R, SAS or SQL is highly desirable.
- Base knowledge of statistical techniques (power analysis, inferential statistics, EDA, sample size estimation) and familiarity of statistical software (SPSS, Gpower, SAS, R) an asset.
- Experience with Database development: eCRF/EDC creation; data entry and data cleaning.
- Must possess superior analytical and creative strengths to identify and implement solutions pertaining to clinical trial project data management.
- Excellent attention to detail and the ability to keep detailed, accurate records efficiently with absolute minimal error.
- General understanding of laboratory procedures, trial assessments and clinic instruments used to generate clinical trial data
- Proficient in MS Office as well as communication tools (Outlook etc.) and clinic management databases / CTMS platforms and EDC systems
- Basic knowledge of statistical methods, with a focused interest on clinical research statistics.
- Must be fluent in English and possess excellent written communication skills; Proficient in reading, writing, and mathematical operations.
- Exceptional interpersonal communication skills and high degree of professionalism; Ability to communicate effectively, orally and in writing to stakeholders, site staff.
- Ability to work individually and as part of a team in a dynamic, efficient clinic, office, and/or remote setting.
- Accountable and accurate, with a strong sense of attention to detail.
- Comfortable handling sensitive and private information while multi-tasking and working in a fast-paced environment.
We value the following qualities in all of our team members:
• High-quality standards, responsibility, and engagement
• Ability to interact with a range of personalities and many levels of the organization
• Demonstrated self-motivation and the ability to take initiative
• Project management and strong prioritization skills
• Attention to and ability to execute details
• Adaptable to changing environment, client, and project needs
Job Type: Full-time
Location: Opportunity to work remotely or in Toronto, ON office.
• Disability insurance
• Dental Care
• Extended health care
• Life insurance
• Vision care
• Wellness program
• Work remotely: