Clinical Document Specialist I

This position reports to the Clinical Document Team Manager. The Clinical Document Specialist I is responsible for first level QC of the eTMF. The Clinical Document Specialist I ensures that all QC work is complete and accurate and delivered in a timely manner to the Clinical Document Specialist III or Clinical Document Team Lead.

The Clinical Document Specialist I will also work on special projects as assigned by the Clinical Document Team Lead and/or the Clinical Document Team Manager.

Responsibilities:

• Review documents in workflow and assign to the team for QC2
• Responsible for QC and review of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO studies
• Answer Q&As in project rooms and ensure they are completed within timeline
• Keep study specific trackers up-to-date and communicate them to the Project Managers
• Attend weekly/biweekly meetings with the Project Managers and discuss project issues and statuses
• Coordinate with Clinical Document Team Leads for project related queries
• Check documents in clarification and rejection status for assigned projects
• Review reports for clarification and rejection monthly before the reports are sent out to the client
• Keep project mappings up-to-date, coordinate with the study leads for requirement of changes to mappings
• Perform internal reviews of assigned eTMFs for audit readiness
• Review internal audit reports and perform corrective actions as required
• Assist with User Acceptance Testing during product development and release
• Work on cross functional teams including Project Management, Business Development, Client Services, Development, and IT on the implementation and management of client projects
• Gather and provide feedback on features and enhancements that may be needed on an ongoing basis to Development Team
• Serve as part as the Project Team on client projects
• Participate and become an expert in the TMF Reference Model and stay current on regulatory changes
• Become an expert in Trial Interactive features and functionality and work with Director of Clinical
• Operations, Project Management, and Development to recommend new features and functionalities to improve the product and reduce manual activities
• Take a proactive role in learning about clients’ industry, business needs and company culture, educating the Project Team, identifying new business opportunities, and providing a high level of service
• Set and fulfill client expectations
• Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor

Required Qualifications, Skills and Experience:

• Knowledge of clinical development phases and processes including GCP and ICH regulations
• Superior written and spoken communication skills in English
• Proficiency in Microsoft Office (Word, Excel, Outlook), and knowledge of eClinical technologies
• Proficiency in Document Management (Adobe professional, knowledge of Scanning, indexing, using ISI Tools and Capture Perfect)
• Minimum High School Diploma or equivalent
• Minimum of 1 year of experience in the Life Sciences industry
• Experience with essential documents and other study documentation

Desired Skills and Experience:

• Bachelor’s Degree from a 4-year college or equivalent
• Previous employment in Pharmaceutical, CRO, Medical Device or Investigative Site
• Experience with essential documents and other study documentation
• Able to multitask in a fast-paced environment
• Work well with people from a variety of different backgrounds and cultures
• Build relationships with clients and co-workers
• Can work independently and as part of a team
• Take active measures to solve problems and commit to a high level of service