Clinical Document Specialist

Job Locations US-MA-Bedford
Posted Date 2 months ago(5/20/2020 9:24 AM)
Job ID
2020-1323
# of Openings
1
Category
Clinical

Overview

The Clinical Document Specialist (CDS) will conduct clinical documentation tracking and trial master file activities. This position is highly visible and interactive with external vendors and cross-functional teams. In addition, the CDS plays a critical role in TMF management activities to ensure adherence to established processes and compliance with applicable global regulations.

Responsibilities

• Under general supervision, develops and maintains internal data repositories for storage of departmental level information
• Conducts trainings for eTMF end users
• Assists with the development and maintenance of trial master file SOPs and work processes including eTMF document workflows and quality control check criteria
• Serves as eTMF system superuser
• May interface with eTMF vendor on system configuration and assists with eTMF implementation activities
• Ensures clinical trial documentation is consistent with TMF specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agency requirements
• Ensures quality checks of TMF content and accuracy of coding are performed
• Communicates issues to applicable representatives to ensure documents which fail TMF quality content and/or TMF inspection readiness review are effectively remediated
• Addresses TMF questions pertaining document workflows and user questions related to the TMF system
• Monitor and identify study-specific TMF trends and escalate concerns to trial management lead
• Conducts TMF inspection readiness assessments and reports metrics to management as applicable
• Provides TMF status reports at study team meetings, participates in collaborative efforts and plays an important cross-functional role in TMF document retrieval and management
• Maintains up to date knowledge of the TMF Reference Model 3.0 and regulatory considerations as applicable to the job duties
• Manages TMF Room entry logs, document check in/check out logs, access, and temperature logs as applicable
• Coordinates the long-term storage archival of original documents and maintain document integrity, per mandatory retention policies.

Qualifications

• BS/BA degree required
• Minimum 4 years clinical research experience with 2 years document management experience
• Previous TMF experience required, including experience in study start-up, maintenance, close-out, and performing quality control and comprehensive completeness reviews
• Extensive knowledge and application of ALCOAC standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R2) guidelines
• Proficient in Word, Excel, PowerPoint and Adobe Acrobat
• Ability to maintain a high level of accuracy and attention to detail in fast-paced environment with shifting priorities
• Approachable and builds constructive, positive, collaborative relationships with key internal stakeholders and external vendors
• Must be proactive, self-motivated, excel at relationship building, and able to work independently
• Must have excellent organizational skills, exhibit professionalism, communicate effectively, have a ‘can do’ approach, solid problem-solving skills, and be a team player

• Ability to travel approximately 20% for meetings and educational seminars

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