Job Category:

Document Assistant

Pay: TBD

Full Job Description

TMF Document Assistant(21002110)DescriptionJOB SUMMARY
Performs quality control (QC) review on Clinical Trial documentation according to Standard Operating Procedures (SOPs)/Work Instructions (WIs) and Trial Master File (TMF) Plans for assigned studies within the electronic TMF (eTMF) system. Identifies any quality issues with the documentation and follows the appropriate query process to have the quality issue resolved.

  • Performs thorough QC of documents for assigned studies according to applicable study specific requirements and SOPs/WIs.
  • Identifies quality issues as applicable and addresses minor corrections and issues queries to the TMF Contributors.
  • Follows-up with TMF Contributors to obtain resolution to queries.
  • Reviews/updates/adds metadata within the eTMF system to documents, as applicable.
  • Participates in project-specific training, as assigned.

Other Responsibilities:

  • Performs other work-related duties as assigned.

QualificationsQUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)
High school education, some college courses in the scientific/regulatory field preferred. Some experience in a clinical trials environment preferred. Strong knowledge of all applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology. Very high attention to detail in reviewing electronic documents. Strong verbal, written, and organizational skills with a team-oriented approach. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Confidence in working independently and remotely using multiple electronic applications. Equipped with reliable internet access and personal computer/laptop. Proficiency in Microsoft Office Suite and email. Ability to meet via WebEx /webcam on a weekly basis.

Primary Location: North America – US Home-Based

Job: Clinical Monitoring

Schedule: Part-time

Travel: No

Employee Status: Temporary

Company – Syneos Health Clinical


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