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Clinical Data Associate
2 months ago
Catawba Research is hiring for a Clinical Data Associate.
Primary Responsibilities:
• Perform data review and query generation.
• Assist in defining edit checks to be programmed for the study/project.
• May assist in the creation and review of programmed edit checks.
• Track study progress and issue periodic status reports.
• Process electronic data received from outside vendors.
• Assist in completing all quality control measures necessary for finalizing and transferring the database and related materials to the sponsor.
• Assisting in updating the database to correct errors.
• Assist in coding Case Report Form (CRF) verbatim terms using Catawba Research or sponsor-supplied dictionaries.
• Identify the achievement of milestones to the project team or Lead Data Manager, e.g. database status as “draft” or “final”
• May act as the Lead Data Manager for assigned studies or project-related work and coordinate with associates.
• May provide training on data management procedures and systems.
• May create & review the data management plan and guidelines for the study/project.
• May assist in the review of the database design.
• Assist in developing and designing CRFs.
Principle Duties and Responsibilities:
• Bachelor's Degree (Pharmacy, Life Science), with 2 to 6 years of experience in Clinical Data Management.
• Experience in MS Office; additional Certification in MS Office or Microsoft Office Specialist (MOS) certification will be an asset.
• Ability to read, write, and speak in English; English proficiency certificate and ability to read, write, and speak in regional Language will be an asset.
• Good Analytical Skill, Attention to detail, Confidentiality and Effective communication skills.
• Familiarity with Medical Terminology; additional Medical Terminology Certificate will be an asset.
• Awareness of all relevant regulations, including ICH-GCP and 21 CFR Part11.
• Ability to work in team environment and to meet team objectives, completion of assigned tasks in a timely manner.
• Effective Mentoring skills.
