Company: Fortrea
Fortrea Official Website
Location: Bangalore
Employment Type: Full-time
Requisition ID: 262504
1. Role Overview
The Central Monitor Assistant supports centralized clinical trial operations through study system management, data review, documentation coordination, and operational support activities.
The role acts as a key operational support function for clinical study teams, ensuring accurate study tracking, compliance, investigator payment coordination, and maintenance of clinical trial systems and documentation.
2. Core Responsibilities
A. Clinical Systems & Database Management
Manage access to clinical systems and study platforms
Maintain and support systems such as:
CTMS (Clinical Trial Management System)
IWRS (Interactive Web Response System)
EDC (Electronic Data Capture)
Support study setup activities for newly awarded projects
Ensure CTMS compliance and data accuracy
B. Data Review & Monitoring Support
Assist with centralized data review activities
Follow up with CRAs on unresolved issues and action items
Support generation and tracking of study-specific reports
Assist Lead monitors with study data review tasks
C. eTMF & Documentation Management
Support eTMF maintenance and document tracking
Assist with:
Document collection
Review and processing
Template management
Filing activities
Ensure documentation compliance throughout study lifecycle
D. Investigator Payment Processing
Review EDC and contract information for payment readiness
Coordinate invoice generation and payment processing
Perform invoice QC and reconciliation activities
Process out-of-pocket and pass-through expenses
Coordinate approvals with CTLs and Project Managers
E. Study Support & Site Start-Up Assistance
Support startup teams with site initiation activities
Assist in preparation of investigator submission packages
Create and manage iSite Packs
Manage project communication and follow-up activities
F. Quality, Compliance & Reporting
Follow SOPs, work instructions, and quality standards
Complete mandatory training requirements on time
Track and report operational metrics
Escalate issues and support resolution processes
Assist with implementation of revised processes and procedures
3. Required Qualifications
Education
University/College degree (Life Sciences preferred)
OR certification in allied health professions:
Nursing
Medical technology
Laboratory technology
Experience
2–3 years of experience in clinical research
Strong knowledge of:
ICH-GCP guidelines
Clinical trial processes
Study coordination workflows
Technical Knowledge
CTMS, EDC, IWRS systems
eTMF management
Clinical operations documentation
Investigator payment workflows
4. Core Skills
Clinical Operations Skills
Centralized monitoring support
Study tracking and coordination
Clinical systems management
Data review and issue follow-up
Documentation & Compliance Skills
eTMF/document management
SOP adherence
Regulatory compliance awareness
Quality checks and audit readiness
Administrative & Operational Skills
Investigator payment coordination
Reporting and metrics tracking
Communication management
Process support and escalation handling
Behavioral Skills
Strong attention to detail
Team collaboration
Organizational ability
Effective written and verbal communication
Consistent quality-focused work approach
5. Key Skill Areas
Clinical Trial Operations
CTMS / EDC / IWRS Systems
eTMF & Documentation Management
Central Monitoring Support
Investigator Payments & Site Coordination
Regulatory Compliance (ICH-GCP)
6. Organizational Context
This role operates within centralized clinical operations in a CRO environment, supporting global study teams by handling operational coordination, documentation management, and centralized monitoring support activities.
It serves as a strong entry-to-mid-level role for progression into:
Clinical Trial Associate (CTA)
In-house CRA
Clinical Data Coordinator
Central Monitor
Clinical Operations Specialist
7. Relative Career Level
Compared to the other roles you shared, this is:
More operational/support-focused than CRA II
Lower seniority than Clinical Sciences Trial Leader
A strong pathway into broader clinical operations and monitoring careers
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