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.
- 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
- Data Analysis: 1 year (Preferred)
- Bachelor's Degree (Preferred)