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Clinical Operations Assistant

2+ years
Not Disclosed
10 Oct. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About This Role

This position is based in India and involves collaboration with teams in Japan, supporting the delivery of work in the region. The role requires direct communication with project teams, investigative sites, and sponsors, with all correspondence conducted in both Japanese and English (written and verbal).

Job Purpose

The Clinical Operations Assistant (COA) is responsible for maintaining the paper and electronic Central Files for Clinical Operations, ensuring efficiency, accuracy, and quality. Responsibilities may include tracking, scanning, filing, and returning Case Report Forms to clients for assigned projects, as well as uploading and naming documents in the electronic document management system. The COA will also support site management team members with local administrative tasks and assist with quality control of Central Files.

Key Accountabilities

  • Track, scan, code, and apply naming conventions to documents, sending them to the appropriate Work In Progress (WIP) and Central File (CF) areas as per the Central File Maintenance Plan.
  • Archive and manage paper documents in the Central Files office according to the Central File Maintenance Plan (CFMP).
  • Photocopy, print, distribute, and retrieve documents as needed.
  • Conduct basic quality checks to ensure accurate document maintenance.
  • Maintain the Clinical Trial Management System (CTMS) and study-specific site trackers (as requested).
  • Monitor compliance with systems and processes, including annual reporting obligations and Site Compliance regarding the Safety Information System (SIS).
  • Organize translations of study documents, liaising with translation companies and managing approvals.
  • Process payments and invoices, including internal follow-up with finance specialists.
  • Coordinate courier shipments of study documents to sites, vendors, and clients.
  • Collect internal signatures for site documents, such as confidentiality and clinical site agreements.

Skills

  • N2 or N3 fluency in Japanese (reading, writing, and speaking).
  • Strong problem-solving skills.
  • Experience in CROs or the Life Sciences industry is preferred.
  • Support document collection, customization, and review for clinical trials in Japan.
  • Liaise with sites and investigators to facilitate project delivery.
  • Collaborate closely with project management teams on assigned tasks.
  • Ensure quality and compliance in all clinical research activities.
  • Ability to prioritize multiple tasks and meet project timelines using strong analytical skills.
  • Excellent interpersonal, verbal, and written communication skills.
  • Sense of urgency in completing tasks and assisting others with study deliverables.
  • Effective time management to meet study needs and departmental goals.

Knowledge and Experience

  • Site management experience or equivalent experience in clinical research, with a solid understanding of clinical trial methodologies and terminology.

Education

  • Degree in biological sciences, pharmacy, or a health-related discipline preferred, or equivalent nursing qualification or relevant experience.
  • N2 or N3 fluency in Japanese (reading, writing, and speaking).