Clinical Trial Documentation Specialist

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), Clinical Research Associate (CRA)
  3. United States
Boston, USA
Posting date: 01 Oct 2020

Proclinical is currently recruiting for a Clinical Trial Documentation Specialist with a biotechnology company located in Boston, MA.

Job Responsibilities:

  • Conducts quality checks of the Clinical TMF documents.
  • Work with internal functional area document owners and CRO to remediate any issues identified with Clinical TMF documents during quality check.
  • Scans, files and maintains study documentation in the Clinical Trial Master Files and in the electronic Trial Master Files system and/or applicable Records Management system.
  • Provides central support for uploading clinical TMF documents to EDMS to support key trial activities (e.g., regulatory submissions, clinical study reports etc.).
  • Work with GDO stakeholders to review and manage operational clinical trial data to ensure quality and completeness per data quality standards and specified system guidelines.
  • Provide centralized data entry support for operational systems ensuring alignment with data quality standards.
  • Review operational data to inform and document trends and risk areas to key stakeholders
  • Support other trial related operational activities as needed and assigned.

Skills and Requirements:

  • BA/BS
  • 1-3 years of industry or comparable experience; candidates with some clinical research educational courses
  • Knowledge of regulatory and Good Clinical Practice (GCP) requirements preferred
  • Understanding of the Trial Master File including understanding of the DIA TMF Reference Model preferred;
  • Experience working in electronic Trial Master File specifically Veeva Vault eTMF platform preferred
  • Proficiency with MS Office Applications, SharePoint, Visio, etc

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.