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Senior Document Specialist

2 months ago

Providence, Rhode Island, United States Evolution Research Group Full time
Job Title: Senior Document Specialist

Evolution Research Group is seeking a highly skilled Senior Document Specialist to join our Regulatory Operations team. As a key member of our team, you will play a critical role in ensuring the efficient and compliant execution of clinical trials.

Job Summary:

The Senior Document Specialist will be responsible for managing and overseeing the electronic Trial Master File (eTMF), ensuring accuracy and accessibility of essential study documents. This position requires strong organizational and communication skills, as well as the ability to work effectively in a team environment.

Responsibilities:
  • Manage, organize, and maintain essential study documents in the eTMF.
  • Perform quality control checks to ensure compliance with ICH GCP Guidelines and the DIA eTMF Reference Model.
  • Reconcile and review documents between the Investigator Site File (ISF) and the eTMF for consistency.
  • Assist in clinical trial start-up and regulatory compliance under the guidance of the Regulatory Operations Specialist.
  • Collect, create, and review essential regulatory documents (e.g., FDA Form 1572) per SOPs and study plans.
  • Serve as a point of contact for IRB submission-related activities, coordinating with the Regulatory Operations Specialist.
  • Support document receipt, processing, and tracking in the eTMF or binder systems.
  • Ensure required documentation is available by coordinating with study sites and relevant parties.
  • Aid in the development and adaptation of site-specific informed consent forms for local compliance.
  • Assist with internal and external eTMF audits to ensure SOP and regulatory guideline compliance.
  • Conduct Quality Control Reviews of the eTMF with functional teams and address feedback.
  • Address audit findings and quality control issues throughout the study, with support from the Regulatory Operations Specialist.
  • Contribute to eTMF management planning and milestone setting.
  • Maintain eTMF file structure and prepare compliance reports for management.
Requirements:
  • High school diploma required, bachelor's degree in biological sciences or related field preferred.
  • Bachelor's degree or equivalent combination of education and 2+ years of eTMF/research experience required.
  • Knowledge of GCP, regulations, eTMF compliance, and auditing processes.
  • Experience with eTMF systems (Veeva preferred) and DIA eTMF Reference Model.
  • Strong understanding of regulatory requirements and clinical trial documentation.
Skills and Abilities:
  • Ability to enter data into PC accurately, including experience working with Microsoft Office.
  • Ability to work effectively and efficiently handling multiple tasks simultaneously.
  • Ability to facilitate a teamwork philosophy with a positive attitude.

We offer a dynamic and supportive work environment, with opportunities for growth and professional development. If you are a motivated and detail-oriented individual with a passion for regulatory compliance, we encourage you to apply for this exciting opportunity.