Data Quality Control Specialist

KGK Science Inc. - London, ON (20 days ago)

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KGK Science is a world-leading Contract Research Organization that specializes in conducting human clinical trials and regulatory services for the Natural Health Product industry. KGK is a dynamic, fast-paced and friendly work environment that will suit an energetic and strategic thinker with clear vision and solid communication skills. This is an opportunity for a highly motivated professional individual seeking to join a respected company in an exciting and growing industry.

The Data Quality Control Specialist ensures that quality-assurance standards and procedures are achieved during the development, design, and maintenance of the study database forms based on the study parameters and protocol outline.

Job Duties:

  • Develop strong understanding of all data related to clinic protocols, procedures and deadlines required for ongoing projects.
  • Perform User Acceptance Testing (UAT) of database forms.
  • Develop training manuals and guidelines for the Clinic that clearly depict how utilize data forms.
  • Read, write, review, and provide training on Data Management SOP’s as required.
  • Maintain comprehension of company processes, and the Data Team’s role within the organizational structure.
  • Perform QC of the database (eCRF) prior to launching and throughout the study.
  • Perform QC of the ePRO (participant’s forms) prior to launching and throughout the study.
  • Direct entry, data management, and version maintenance of eCRF and ePRO, including plan, execution, and delivery.
  • Complete data extraction and QC of Data extraction.
  • Validation of queries as required by Clinic and Clinical Research Associates.
  • Perform QC of the sample and final database/datasets to be submitted to the Quality Assurance and Biostatisticians/Research Team.
  • Assist with database training for CRC’s, CRA’s and other departments as required.
  • Create and manage users in the database for internal and external sites.
  • Build and/or QC study skeleton as per requirements of study design.
  • Create and QC TDS (Trial Data Specifications), DataMap file, disposition numbers, and IRB submission documents including Logic Document and participant manuals.
  • Actively communicate with various departments, including CRAs/Monitors, QA and Clinic as required.

Required Education, Skills and Qualifications

  • Bachelors degree in related field
  • Strong skills in MS Office, MS Access and Excel, understanding of the fundamentals of computers
  • XLSForm and SQL knowledge is an asset
  • Excellent attention to detail and strong analytical skills
  • Proficient verbal and written communication skills
  • Ability to prioritize tasks/deadlines and effective time management skills
  • Flexibility and ability to work both independently and in a team setting environment
  • Knowledge of clinical research and regulatory environments is an asset
  • Excellent problem-solving capabilities

Job Types: Full-time, Permanent

Experience:

  • Data Analysis: 1 year (Preferred)

Education:

  • Bachelor's Degree (Preferred)

Location:

  • London, ON (Required)