Associate Site Report Specialist – Clinical Research (Home-Based)
Location: Ahmedabad, India
Employment Type: Full-Time
Work Model: Home-Based
Industry: Clinical Research / CRO / Pharmaceutical
A leading global clinical research organization, IQVIA, is hiring an Associate Site Report Specialist to support high-quality clinical trial oversight through structured review of Site Visit Reports (SVRs). This role plays a critical part in ensuring subject safety, data integrity, regulatory compliance, and overall trial quality across global clinical studies.
Job Overview
The Associate Site Report Specialist is responsible for reviewing Site Visit Reports (SVRs) and associated documentation to ensure compliance with study protocols, ICH-GCP guidelines, and organizational SOPs. The position focuses on quality assurance, risk identification, issue escalation, and process optimization to enhance clinical trial performance.
This is a remote opportunity suitable for experienced clinical research professionals with strong on-site monitoring and regulatory expertise.
Key Responsibilities
Review and manage a caseload of SVRs across assigned clinical studies
Ensure reports meet protocol requirements, GCP standards, and internal SOPs
Verify documentation of corrective and preventive action plans (CAPA) and ensure follow-up to resolution
Identify and escalate CRA/site issues, quality trends, and risk indicators to project teams
Provide guidance to Clinical Project Managers (CPMs) and project teams to reduce report revisions
Monitor compliance with SVR submission and approval timelines
Participate in project team meetings to address quality or performance gaps
Provide coaching and mentoring to CRAs to improve reporting standards
Support quality improvement initiatives including data trending and quality checks
Contribute to special projects aligned with departmental or corporate initiatives
Experience Level: Senior Associate / Mid-Senior Level
Experience Required:
7–8 years of clinical research experience
Minimum 3–4 years of on-site monitoring experience as a CRA
Strong working knowledge of ICH-GCP guidelines and global regulatory requirements
Experience reviewing monitoring reports and managing site compliance issues
Educational Qualification
Bachelor’s Degree in Healthcare, Life Sciences, or related scientific discipline
Equivalent combination of education and relevant experience may be considered
Core Competencies
In-depth knowledge of clinical monitoring processes
Strong understanding of clinical trial systems and documentation standards
Experience managing complex study designs and multiple projects
Strong analytical and problem-solving skills
Excellent written and verbal communication skills (Fluent English required)
Effective time management and ability to manage competing priorities
High attention to detail and quality-oriented mindset
Ability to work independently in a remote environment
Experience working across diverse cultures and global geographies
About the Organization
IQVIA is a global leader in clinical research services, healthcare analytics, and commercial insights. The organization partners with life sciences companies to accelerate drug development and improve patient outcomes worldwide through data-driven innovation and operational excellence.
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