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Central Monitor Assistant

Fortrea
2-3 years
Not Disclosed
Bangalore, India
10 May 19, 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

Job Title

Central Monitor Assistant

Location

Bangalore, India

Employment Type

Full-time

Job Requisition ID

262504

Application Deadline

June 30, 2026


Role Overview

The Central Monitor Assistant provides operational, administrative, and technical support to clinical study teams. The role involves managing clinical trial systems, supporting study documentation and data review activities, coordinating investigator payments, and ensuring compliance with clinical research processes and regulatory requirements.

The position supports clinical trial operations throughout the study lifecycle, including study setup, maintenance, monitoring support, and closeout activities.


Key Responsibilities

1. Clinical Systems & Database Management

  • Manage clinical systems and user access

  • Maintain study databases, including:

    • CTMS (Clinical Trial Management System)

    • IWRS (Interactive Web Response System)

    • EDC (Electronic Data Capture)

  • Perform system setup for newly awarded studies

  • Ensure CTMS compliance management


2. Study Support Activities

  • Support study teams in:

    • eTMF management activities

    • Data review activities

    • Study documentation management

  • Generate study-specific reports

  • Manage project communications

  • Assist study startup teams with site startup activities

  • Support upload management and query follow-up activities


3. Data Review & Monitoring Support

  • Follow up with CRAs regarding outstanding issues and action items

  • Assist study leads with study-specific data review tasks

  • Perform quality checks on completed work

  • Ensure timely escalation and issue resolution


4. Investigator Payment Processing

  • Review EDC and contract information

  • Mark payment line items as:

    • Ready to Pay

    • Screen Failure

  • Coordinate payment batch generation in CTMS

  • Perform invoice quality control (QC)

  • Prepare GIA documentation where applicable

  • Coordinate approvals with CTL and Project Managers

  • Process:

    • Out-of-pocket expenses

    • Pass-through invoices

  • Perform payment reconciliation during study closeout or upon request


5. Documentation & eTMF Support

  • Assist in document management activities, including:

    • Template creation

    • Document collection

    • Review and processing

    • Tracking and eTMF filing

  • Assist with investigator submission packages

  • Support site/regulatory submission preparation


6. Compliance & Quality Management

  • Follow departmental SOPs and work instructions

  • Complete required trainings within timelines

  • Ensure quality and productivity standards are met

  • Track and report operational metrics

  • Assist in implementation of revised processes and procedures


7. Additional Responsibilities

  • Support site clinical trial contract management activities

  • Create iSite Packs

  • Provide administrative and technical support to internal teams

  • Perform additional duties assigned by management


Required Qualifications

Education

  • University/College Degree in:

    • Life Sciences (preferred)

    • Allied Health Profession

  • OR certification from an accredited institution, such as:

    • Nursing

    • Medical Technology

    • Laboratory Technology

Equivalent relevant experience may be considered in place of formal education.


Required Experience

  • 2–3 years of experience in clinical research

  • Strong knowledge of:

    • ICH-GCP guidelines

    • Clinical research regulations and processes

  • Experience using clinical trial systems and departmental tools


Required Skills & Competencies

Technical & Operational Skills

  • Experience with clinical trial systems:

    • CTMS

    • EDC

    • IWRS

    • eTMF

  • Good computer and documentation management skills

  • Ability to manage multiple tasks efficiently

Communication & Teamwork

  • Fluent in English (written and verbal)

  • Strong organizational and communication skills

  • Ability to work collaboratively with cross-functional teams

Quality & Performance

  • Strong attention to detail

  • Ability to deliver consistent, high-quality work

  • Strong problem-solving and issue escalation skills


Work Environment

  • Office-based clinical research environment

  • Collaborative and process-driven setting

  • Involves coordination with study teams, CRAs, project managers, and finance teams


Role Summary

The Central Monitor Assistant plays a key support role in clinical trial operations by managing study systems, documentation, data review, investigator payments, and compliance activities. The role requires strong organizational skills, clinical research knowledge, and the ability to support multiple operational processes across the study lifecycle.