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    Clinical Operations Assistant

    Parexel
    2+ years
    Preferred by Comapny
    Bengaluru
    11 Nov. 25, 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

    Job Title: Clinical Operations Assistant (COA)

    Location: India (Supporting Teams in Japan)
    Company: Parexel

    Job Purpose

    The Clinical Operations Assistant (COA) is responsible for maintaining accurate and efficient Central Files for Clinical Operations, including both paper and electronic documentation. This role requires working closely with project teams, investigative sites, and sponsors, ensuring compliance with regulatory and quality standards.

    The position involves collaboration with teams in Japan, with all communication in Japanese and English, both written and verbal.

    Key Accountabilities

    • Document Management:
      • Track, scan, code, and name documents according to the Central File Maintenance Plan (CFMP).
      • File and archive paper documents and upload electronic records to document management systems.
      • Conduct quality checks to ensure document accuracy and compliance.
    • System Tracking:
      • Maintain and monitor Clinical Trial Management Systems (CTMS) and study-specific site trackers.
      • Track reporting obligations and ensure compliance with safety information systems (SIS).
    • Administrative Support:
      • Organize translations of study documents, liaising with translation vendors.
      • Process payments and invoices, coordinating with internal finance teams.
      • Courier shipments of study documents to sites, vendors, and clients.
      • Collect internal signatures for site documents such as confidentiality and clinical site agreements.
    • Team Support:
      • Assist site management team members with local administrative tasks.
      • Support Quality Control (QC) of Central Files and other project deliverables.
    • Liaison:
      • Work with Japanese sites and investigators to support clinical trial activities.
      • Facilitate collaboration between local and international project management teams.

    Skills & Competencies

    • Language Proficiency:
      • Fluency in Japanese (N2, N3 level) for reading, writing, and speaking.
      • Strong English communication skills (verbal and written).
    • Technical & Administrative:
      • Strong document management and organizational skills.
      • Knowledge of clinical trial methodologies and terminology.
      • Proficiency in using electronic document management systems and trackers.
    • Interpersonal & Analytical:
      • Effective problem-solving and decision-making abilities.
      • Strong interpersonal and professional interaction skills.
      • Time management and prioritization skills to meet project deadlines.
    • Attention to Detail:
      • Ensure high-quality standards in document management and study deliverables.

    Knowledge & Experience

    • Experience in Site Management or equivalent roles within clinical research.
    • Familiarity with clinical trial processes and methodologies.
    • Prior experience in CROs or the life sciences industry is preferred.

    Educational Qualifications

    • Degree: Biological sciences, pharmacy, health-related disciplines, or equivalent.
    • Other Qualifications: Nursing qualification or equivalent experience.

    Why Join Parexel?

    Join a global leader in clinical research, work on cutting-edge projects, and play a critical role in advancing healthcare innovations. Collaborate with international teams and develop your career while contributing to life-changing clinical trials.

     

     

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