Primary Objective of Position
The Document Specialist is responsible for assisting the Clinical Operations team with the day-to-day document naming, filing and maintenance activities for one or more clinical trials during the study start-up, maintenance and close-out periods.
? Maintains effective communication with project teams, CRO staff, and eTMF vendor personnel throughout study start-up, maintenance and close-out.
? Uploads, maintains and reconciles study documents in the Trial Master File (TMF).
? Maintains a naming and filing guide specific to Clinical Operations documents.
? Performs quality check of documents uploaded by CRO staff.
? Responds to inquiries regarding eTMF management and contents.
? Attends departmental and study-specific meetings and discussions, as required.
? Runs eTMF reports, as required.
? Performs general administrative tasks.
? Completes other study document-related tasks as required by the study teams, the Director of CQL, or the Vice President of Clinical Operations.
Skills & Abilities
? Clear and timely communication of eTMF/document status and activities.
? Proactive identification and resolution/escalation of project-related eTMF/document issues.
? Ability to work independently on routine assignments or under supervision on new assignments.
? Ability to handle a moderate volume of complex tasks within a given timeline.
? Strong organizational skills and ability to prioritize.
? Ability to build relationships across and up and down the organization.
The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.
Rare travel (including air) may be required. This may include carrying a laptop, lifting luggage and possibly long flight times.
Education & Professional Experience
? Bachelor’s degree or equivalent experience.
? Recognition and understanding of clinical research documents, their contents and purpose.
? Understanding of GCP and knowledge of regulatory requirements.
? 1-2 years of clinical trial experience (e.g., study coordinator, data management, site monitoring and/or nursing).
? 1-2 years of electronic TMF document management experience.