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Central Monitor Assistant

Fortrea
Fortrea
2-3 years
Not Disclosed
Bangalore, India
10 May 18, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Central Monitor Assistant

Location: Bangalore, India
Employment Type: Full-Time
Job ID: 262504
Application Deadline: June 30, 2026


Role Overview

The Central Monitor Assistant supports clinical study operations by managing clinical systems, assisting with data review activities, maintaining study documentation, and ensuring compliance with study processes and regulatory standards. This role works closely with study management teams to ensure smooth execution of clinical trial activities.


Key Responsibilities

Study Systems & Documentation

  • Manage clinical systems access (CTMS, EDC, IWRS, etc.)

  • Maintain study databases and ensure data accuracy

  • Support eTMF (electronic Trial Master File) management activities

  • Assist with system setup for newly awarded studies

  • Support document management, including collection, tracking, and eTMF filing

  • Ensure CTMS compliance and proper documentation practices


Data Review & Reporting

  • Support data review activities and assist in resolving outstanding issues

  • Follow up with CRAs on action items and data queries

  • Assist in generating study-specific reports and metrics

  • Track and escalate issues as required

  • Ensure timely completion of data-related tasks with high quality


Study Support Activities

  • Provide operational support to study teams across ongoing activities

  • Assist in preparation of investigator submission packages for regulatory/site submissions

  • Support site start-up activities and study initialization tasks

  • Manage project communications and coordination with stakeholders

  • Assist in implementation of updated processes and procedures


Investigator Payments & Finance Support

  • Review EDC, contracts, and mark payment-ready items in CTMS

  • Support preparation of invoices, cover letters, and payment batches

  • Perform invoice quality checks (QC) and generate required documentation

  • Coordinate approvals with study teams (CTL, PM, etc.)

  • Process out-of-pocket and pass-through expenses

  • Support payment reconciliation during study close-out or ad hoc requests


Compliance & Quality

  • Follow all applicable SOPs, work instructions, and regulatory guidelines (ICH-GCP)

  • Complete required training within defined timelines

  • Ensure high-quality and timely execution of assigned tasks

  • Perform quality checks on completed work

  • Escalate issues appropriately and in a timely manner

  • Support audits and compliance-related activities


Qualifications

  • University or college degree (Life Sciences preferred), or allied health certification (e.g., nursing, medical or laboratory technology)

  • 2–3 years of experience in clinical research or related roles

  • Strong understanding of ICH-GCP guidelines and clinical trial regulations

  • Fluent in English (written and verbal)

  • Equivalent experience may be considered in lieu of formal education


Required Skills & Competencies

  • Strong organizational and coordination skills

  • High attention to detail and accuracy

  • Ability to work effectively in cross-functional teams

  • Strong communication skills

  • Proficiency in using clinical systems and standard office tools

  • Consistent delivery of high-quality work

  • Ability to manage multiple tasks and deadlines efficiently


Role Summary

The Central Monitor Assistant plays a key operational role in supporting clinical trial execution, ensuring data integrity, system compliance, and efficient coordination across study teams. The position requires strong attention to detail, reliability, and familiarity with clinical research processes.