Clinical Operations Assistant

0-2 years

Not Disclosed

Bangalore

10 March 19, 2025

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)
Company: [Insert Company Name]
Location: [Insert Location]

About This Role:
The Clinical Operations Assistant (COA) is responsible for managing both paper and electronic Central Files for Clinical Operations, ensuring that all tasks are performed with efficiency, accuracy, and high quality. The COA will track, scan, file, and upload documents to the electronic document management system, and support site management team members with administrative tasks. The role also includes quality control of central files and assisting with various activities related to the Clinical Trial Management System (CTMS) and other study-specific systems.

Key Accountabilities:

Track, scan, code, and apply naming conventions to documents, ensuring they are sent to the relevant study Work In Progress (WIP) and Central File (CF) areas of PMED according to the Central File Maintenance Plan (CFMP).
File and archive paper documents in the Central Files office location in accordance with the CFMP.
Photocopy, print, distribute, and retrieve documents as required.
Perform basic quality checks to ensure the accurate maintenance of clinical trial documents.
Track and maintain the Clinical Trial Management System (CTMS) and study-specific site trackers (only when requested by the client).
Monitor the status of systems and processes, including annual reporting obligations and site compliance with safety information systems (SIS), to ensure full compliance.
Organize translations of study documents, working with translation companies and ensuring timely delivery of translations.
Process payments/invoices and follow up with payment specialists in the finance department.
Coordinate courier shipments of study documents to sites, vendors, and clients.
Collect internal signatures for site documents, including confidentiality and clinical site agreements, within Parexel.

Skills & Qualifications:

N2 or N3 fluency in Japanese (reading, writing, and speaking).
Strong problem-solving skills.
Prior experience working in CROs or the Life Sciences industry preferred.
Support with document collection, customization, and review for clinical trials in Japan.
Liaise with sites and investigators on assigned projects to ensure smooth project delivery.
Collaborate closely with project management teams to ensure project goals are met.
Ensure quality and compliance in all clinical research activities.
Strong interpersonal, verbal, and written communication skills.
Ability to prioritize tasks, work autonomously, and meet project timelines.
Ability to manage time effectively to meet study needs and department goals.
Ability to work under pressure while maintaining quality standards and deadlines.

Knowledge & Experience:

Experience in site management or equivalent experience in clinical research, with an understanding of clinical trials methodology and terminology.

Education:

Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other relevant experience.

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Clinical Operations Assistant

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