eTMF Document Specialist

Location: This position will be assigned to the Amherst, NY office but consideration will be made for a full time remote employee.

Description:

The eTMF Document Specialist for Frontier Science will be responsible for oversight of studies within Frontier Science’s electronic Trial Master File (eTMF) with a specific focus on ensuring that documents are uploaded in a timely manner and in compliance with network and project specific SOPs. In addition, the eTMF Document Specialist will assist the eTMF Administrator with configuration validation and executing test cases as needed.

Major duties and responsibilities:

  • Serve as the primary point of contact for oversight of studies in the Frontier Science eTMF
  • Run reports to monitor document upload time to ensure documents are upload in compliance with network and project specific timelines
  • Work with data management staff to ensure that eTMF milestones are added in a timely manner and resulting expected document lists are edited to be accurate
  • Run reports to monitor eTMF completeness to ensure expected documents are available as expected
  • Generate and share eTMF timeliness and completion reports with project leadership and sponsor representatives as needed
  • Follow-up with eTMF document uploaders as needed when project timelines and expectations are not met
  • Escalate chronic issues of non-compliance to project leadership
  • Assist the eTMF Administrator with validation activities related to eTMF version updates or configuration change
  • Review eTMF controlled documents and ensure compliance regarding eTMF implementation
  • Assist staff in using the eTMF.

The responsibilities listed above are not a comprehensive list, and the employee may be asked to perform other professional tasks with reasonable consideration as necessitated by business demands.

Reports to: ACTG/IMPAACT DMC Associate Director

Controls over position: The eTMF Document Specialist will be assigned work by the ACTG/IMPAACT DMC Associate Director, and as needed by other Frontier Science Leadership members in accordance with project needs and deliverables.

Required Qualifications:

  • Bachelor's Degree in a science or health related industry
  • Understanding of GCP regulations and clinical trials
  • Minimum one year of experience utilizing an eTMF
  • Proficient with all Microsoft Office programs
  • Excellent communication skills, both written and verbal
  • Strong attention to detail with the ability to multi-task.

Travel:

This position will be based out of the Amherst, New York office. Even if full time remote, the employee may be asked to report to the Amherst office as needed. In addition, the employee may be requested to travel to the organization's other office locations based in Boston, Massachusetts and Madison, Wisconsin.

Physical Conditions:

This is a stationary position that will require the employee to operate office equipment including a computer, fax machine, and printer.

Applications will be received through the ADP Workforce Now Career Center using the following link: ADP Workforce Now Frontier Science Career Center.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.