Clinical Research Data Analyst

2 weeks ago

Vancouver, Canada The University of British Columbia Full time
Job Summary
The Clinical Research Data Analyst (CRDA) is responsible for research data management (RDM) activities involving the design, administration, data collection, validation, and testing of various CCI clinical trials and registries. The individual will be responsible for the creation and maintenance of databases relating to various clinical trials, ensuring that the data collected is accurate and grouped properly, solving any operational problems, and preparing insightful statistical reports.

Organizational Status
The CRDA will report to the the CCI Director of Research Operations. The CRDA will work closely with other staff to fulfill the operational requirements of the research group.

Work Performed
  • Performs all tasks related to the creation and maintenance of the databases of multiple clinical research studies
  • Reviews research protocols to provide data collection-related feedback
  • Develops a Data Management Plan (DMP) and a Data Validation Edit Check Plan for each trial/study
  • Collaborates with CCI team members on data collection plans for clinical trial databases and registries, data transfers, data cleaning, creating and analyzing large datasets, and other data management issues relevant to research
  • Use strict validation procedures to guarantee the integrity and correctness of the research data that has been gathered
  • Expertly apply analytical techniques and tools to validate the data collected, and extract significant insights and create periodic reports
  • Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
  • Develops and refines project DM documentation (DMP, Data Validation Plans, etc.) based on good RDM practices
  • Develop Case Report Form (CRF), electronic and/or paper, in consultation with the Clinical Study Coordinator
  • Create standards in CRF setup and edit checks to ensure consistency and efficiency in database development
  • Participates in the review of Clinical research documents (e g. Protocols, Case Report Forms, Reports, and Statistical analysis) and provides guidance on RDM practices
  • Develop standard procedures/reports to validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines
  • Query data inconsistencies and revise case report forms in compliance with standard operating procedures and up-to-date research data management systems
  • Extract and monitor the trial data to identify issues
  • Participates in the preparation and presentation of research data, when applicable.
  • Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
  • Identify and fix operational issues with data processing and gathering. Provide and enact strategies to improve data management procedures.
  • Adhere to quality assurance measures to ensure data accuracy and reliability
  • Train other junior members or inexperienced staff


Consequence of Error/Judgement

Errors in the management of data could result in inaccurate data sets, inadequately analyzed data, as well as the loss of productivity for the investigators and the potential loss of grant or other research funding.

Lack of careful attention to regulatory guidelines and approvals could suspend Investigator/physician and hospital/University as a site for further clinical research and/or funding. The performance of clinical trials and research projects must strictly conform to appropriate regulations: 1) personal: maintaining professional behavior and respect for subjects and staff 2) local: the UBC Clinical Research Ethics Board 3) Provincial: B.C. Privacy Act 4) Federal: Health Canada, International Conference on Harmonization, Tri-Council Policy Statement, Good Clinical Practice and 5) International: U.S. Food & Drug Administration.


Supervision Received
This individual will be expected to work independently in accordance with established objectives and exercise initiative and judgment in performing all work-related functions. Work with general direction and supervision from the Clinical Research Database Manager and Director of Research Operations as part of a collaborative team.

Supervision Given
Provide training to new or inexperienced research staff, as needed.

Minimum Qualifications
Undergraduate degree in a relevant discipline. Minimum of two years of related experience, or the equivalent combination of education and experience.

- Willingness to respect diverse perspectives, including perspectives in conflict with one’s own

- Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion

Preferred Qualifications

  • Bachelor’s degree, or recognized equivalent, in Computer Science, Mathematics or Statistics.
  • Clinical research data management experience in a health-related setting
  • Experience with clinical data collection, monitoring/auditing as well as clinical trial documentation using Electronic Data Capture systems is required
  • Experience using Database Management systems such as, iDataFax/ DFDiscover and RedCap preferred.
  • Knowledge and experience in statistical software SAS and other relevant software platforms such as Oracle InForm, PL/SQL, Visio preferred.
  • Knowledge of ICH/GCP guidelines
  • Excellent project management skills
  • Strong analytical and problem-solving skills
  • Demonstrated ability to express complex technical concepts effectively
  • Mentor/training experience
  • Strong verbal and written communication skills
  • Exceptional organizational skills and customer relations
  • Excellent problem recognition and problem-solving abilities
  • Excellent listening, conflict resolution skills
  • Client service oriented, with the ability to effectively work with diversity

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