Associate Site Report Specialist (Clinical Research)
Location: Kolkata, India (Home-Based)
Job Type: Full-Time
Industry: Clinical Research / Contract Research Organization (CRO)
Job Overview
A leading global clinical research organization is seeking an experienced Associate Site Report Specialist to ensure the quality, accuracy, and regulatory compliance of Site Visit Reports (SVRs) across assigned clinical trials. This home-based opportunity in Kolkata supports global study delivery by safeguarding subject safety, data integrity, and adherence to ICH-GCP guidelines and internal SOPs.
The ideal candidate will bring substantial experience in clinical research monitoring, regulatory documentation review, and quality oversight within multinational clinical trials.
Key Responsibilities
Review and manage a defined caseload of Site Visit Reports (SVRs) for assigned clinical studies.
Ensure compliance with study protocols, regulatory requirements, timelines, and organizational SOPs.
Verify documentation of corrective and preventive action plans (CAPA) and ensure follow-up to resolution.
Identify and escalate site issues, CRA performance gaps, emerging trends, and risk factors to project teams.
Provide strategic guidance to Clinical Project Managers (CPMs) at study start-up and throughout trial conduct.
Monitor adherence to SVR submission and approval timelines through coordination with CRAs and line managers.
Participate in cross-functional project meetings to address quality concerns and performance trends.
Mentor and coach CRAs to enhance documentation quality and minimize report corrections.
Support quality improvement initiatives including quality checks, data trending, and issue escalation analysis.
Contribute to corporate or functional projects aligned with clinical quality and compliance excellence.
Minimum Qualifications & Experience
Bachelor’s degree in Healthcare, Life Sciences, Pharmacy, Nursing, or related scientific discipline.
7–8 years of clinical research experience.
Minimum 3–4 years of on-site monitoring experience as a Clinical Research Associate (CRA).
Strong expertise in ICH-GCP guidelines and global clinical research regulatory requirements.
Comprehensive understanding of clinical monitoring processes and clinical trial management systems.
Demonstrated experience managing complex or multi-study clinical environments.
Fluency in English, both written and spoken.
Core Competencies
High attention to detail and strong quality orientation.
Excellent analytical, documentation, and problem-solving skills.
Effective time management and ability to prioritize competing deadlines.
Strong verbal and written communication skills.
Ability to work independently in a remote, home-based environment.
Demonstrated experience collaborating across cultures and global geographies.
Strong stakeholder engagement and relationship-building skills.
Why This Role Is Critical
The Associate Site Report Specialist plays a key role in strengthening inspection readiness, enhancing clinical trial documentation quality, and ensuring regulatory compliance across global research programs. By improving SVR accuracy and consistency, this role directly contributes to successful study execution and regulatory confidence.
Equal Opportunity & Integrity Commitment
The organization maintains strict integrity standards and a zero-tolerance policy toward recruitment fraud. Employment decisions are based on merit, qualifications, and applicable regulatory standards. All applicants are expected to provide accurate and complete information during the hiring process.
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