Associate Site Report Specialist (Clinical Research)
Location: Ahmedabad, India (Home-Based)
Job Type: Full-Time
Industry: Clinical Research / Contract Research Organization (CRO)
Job Overview
A leading global clinical research organization is hiring an Associate Site Report Specialist to support quality oversight of Site Visit Reports (SVRs) across assigned clinical trials. This home-based position in Ahmedabad plays a critical role in ensuring subject safety, data integrity, regulatory compliance, and adherence to ICH-GCP guidelines and organizational SOPs.
The role requires strong experience in clinical monitoring, regulatory documentation review, and quality control within global clinical trials. The ideal candidate will possess prior CRA monitoring experience and the ability to identify compliance risks, escalate issues, and drive report quality improvements.
Key Responsibilities
Manage and review a portfolio of Site Visit Reports (SVRs) for assigned clinical studies.
Ensure compliance with study protocols, timelines, internal SOPs, and ICH-GCP regulatory requirements.
Verify documentation of corrective and preventive action plans (CAPA) and ensure follow-up to resolution.
Identify and escalate CRA performance issues, site-related risks, and emerging compliance trends to project teams.
Provide guidance to Clinical Project Managers (CPMs) during study start-up and throughout trial execution.
Track and monitor adherence to SVR submission and approval timelines.
Participate in cross-functional meetings to address quality or performance deficiencies across sites and CRAs.
Provide coaching and mentoring to CRAs to enhance report quality and reduce corrections.
Support quality improvement initiatives, including data trending, issue escalation analysis, and backup review support.
Contribute to special projects aligned with corporate or functional quality initiatives.
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 knowledge of ICH-GCP guidelines, global regulatory requirements, and clinical trial compliance standards.
In-depth understanding of clinical monitoring processes and clinical trial systems/applications.
Experience handling complex study designs and multi-study environments.
Fluency in English (written and spoken).
Core Competencies
Strong analytical thinking and problem-solving skills.
Excellent written and verbal communication skills.
High attention to detail and strong quality orientation.
Effective time management and ability to manage multiple priorities.
Ability to work independently in a remote, home-based setting.
Demonstrated ability to collaborate across geographies and cultures.
Strong stakeholder management and relationship-building capabilities.
Why This Role Is Important
The Associate Site Report Specialist directly contributes to the integrity and quality of global clinical trials. By ensuring high-quality SVR documentation and regulatory compliance, this role supports inspection readiness, patient safety, and successful study execution across international research programs.
Equal Opportunity & Integrity Statement
The organization maintains a strict commitment to integrity, transparency, and equal employment opportunity. All applicants are evaluated based on qualifications, experience, and merit. Any misrepresentation during the hiring process may result in disqualification in accordance with applicable laws.
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