Clinical Data Coordinator

Job Responsibilities:

• Review protocol and attend protocol review meetings or provide feedback, as needed.
• Develop eCRF specification, data validation plan, DMP, and other data management documents under the guidance and support of the lead data manager.
• Perform UAT under the guidance and support of the lead data manager.
• Provide study metrics and status reports to internal and/or client teams.
• Perform data cleaning activities under the guidance and support of the lead data manager.
• Perform SAE reconciliation activities under the guidance and support of the lead data manager.
• Perform external data reconciliation activities under the guidance and support of the lead data manager.
• Perform database lock activities under the guidance and support of the lead data manager.
• Assist with ongoing filing and archiving of data management documents as directed, including the filing and archiving of such documents in the TMF.
• Ideally, 3 plus or more years of relevant work experience, or equivalent combination of training and experience.
• Familiar with electronic data collection systems
• Preferred knowledge of data management best practices & technologies as applied to clinical trials.
• Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management processes.