Job Title:

 Clinical Data Coordinator

Department:

 Clinical Development & Regulatory Affairs

Description:

The purpose of this position is to review and process clinical trial data
to ensure the accuracy and consistency of clinical databases in
accordance with GCPs and SOPs, in order to assess the safety and
efficacy of investigational products.

Reports to: Director, Clinical Operations

Responsibilities:

• Develops an understanding of clinical trials research through exposure to research protocols and a variety of therapeutic areas.
• Uses Electronic Data Capture systems to review or update data, and generate manual data queries and data status reports.
• Tracks and reconciles data received for in-house review through use of existing CRF tracking tools.
• Applies corrections and/or updates to the clinical database and appropriate documents (original and/or working copies) that are identified through query resolution, data entry, text review, study conventions, site request, computerized validation, and/or data importing.
• Performs reconciliation of similar data between multiple data sources.
• Previews data listings to check accuracy and completeness of clinical data.
• Performs QC of the clinical database against query results, data merges and data updates.

Requirements:

• BS/BA degree.
• 1-2 years minimum experience in data management required, clinical data experience valuable.
• General knowledge of applicable clinical research regulatory requirements; including GCP and ICH guidelines.
• Strong computer skills including proficiency in use of Microsoft Word and Excel.
• Strong written and verbal communication skills.
• Effective time management and organizational skills.
• Strong attention to detail and skill with numbers
• Good analytical/problem-solving skills.
• Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines and Targacept SOPs.
• Ability to work proactively with moderate supervision.
• Ability to work in a team environment and independently, as needed.
• Adaptable to various situations and can adjust to shifting priorities.