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Job Description
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.