Clinical Research Data Associate

Position: Clinical Research Data Associate

Job Summary:

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.

Job Responsibilities:

  • 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.

Qualifications:

  • 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.

Benefits Include:
• Disability insurance
• Dental Care
• Extended health care
• Life insurance
• Vision care
• Wellness program
• Work remotely:

Applying:
To be considered for future opportunities, please email your cover letter, resume/CV, and any related supporting documentation to hr@dicentra.com with “Clinical Research Data Associate ” in the subject line.

As part of the hiring process, in addition to interviewing, successful candidates may be required to complete a skills assessment and a reference/background check. If you are sent a skills assessment, please complete it for consideration for the advertised position.

We thank all applicants for their interest, however, only those selected for an interview will be contacted.

Inclusion:
dicentra is firmly committed to creating a welcoming, accessible, respectful, and inclusive environment at our company in all divisions. We support the safety of employees and clients of diverse backgrounds and experiences. We also strive to meet individualized accessibility to ensure full inclusion for everyone. If you are selected to proceed through the hiring process and need a reasonable accommodation, please inform the company representative that contacts you.

About dicentra:

dicentra is a contract research organization and professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries. We evaluate, implement, and provide all the necessary support for our client’s products and operations, allowing them to gain market access while building confidence in their brand.

We achieve this through our four business divisions:
Life Sciences Consulting
Food Safety & Quality Consulting
Global Certifications
Clinical Trials

Our team of experts work collaboratively to protect and improve our client’s businesses. We strive to promote a dynamic environment and encourage our team to continuously develop and enhance their skills and expertise, resulting in innovative solutions for our clients.