• Charleston, SC, USA
  • Full Time

Job Title: Regulatory Associate I

Department: Clinical Operations

Reports To: TMF Manager

The Regulatory Associate I (RA I) is responsible for the maintenance of Trial Master File related records, including but not limited to receiving, reviewing, indexing, scanning, filing, to ensure compliance with relevant regulations, internal standard operating procedures, and industry standards surrounding the Trial Master File.

Primary Responsibilities

  • Upload study records to applicable eTMF platform.
  • Ensure all records, paper and electronic, are accurately catalogued and filed.
  • Scans documents as applicable.
  • Utilizes various eTMF platforms.
  • Performs thorough QC of documents for assigned studies according to applicable study specific requirements and SOPs/Work Instructions.
  • Adheres to TMF Reference Model filing structure and/or applicable study-specific file plan.
  • Identifies quality issues as applicable and issues queries to the Document Owners.
  • Follows-up with Document Owners to obtain resolution to queries.
  • Reviews/updates/adds metadata within the eTMF system to documents, as applicable.
  • Assist with tracking, review and mitigation of TMF inventory gaps for clinical studies.
  • Assist with Inspection Readiness preparation activities related to TMF in compliance with applicable laws and regulations.
  • Assist with final quality reviews as needed to ensure a complete study TMF. Assist with study archival planning and related activities.
  • Provide support during audits and/or regulatory Inspections.
  • Participates in project-specific training, as assigned.
  • Adhere to TMF SOP's and other relevant TMF process supporting guidance's.
  • Adhere to Guideline for Good Clinical Practice (ICH GCP).

Knowledge, Skills and Abilities

  • 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.
  • Strong verbal, written, and organizational skills with a team-oriented approach.
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment.
  • Proficiency in Microsoft Office Suite, Adobe Acrobat and web-based systems.
  • Proficiency in prioritization skills, flexibility and attention to detail.
  • Strong critical/analytical thinking while being process driven.
  • This job has no supervisory responsibilities.

Education and Experience

Bachelor's degree preferred.

High school education, some college courses in the scientific/regulatory field acceptable.

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