Associate Site Report Specialist (Clinical Research)
Location: Bengaluru, India (Home-Based)
Job Type: Full-Time
Industry: Clinical Research / CRO
Job Overview
A leading global clinical research organization is seeking an Associate Site Report Specialist to review and ensure the quality, accuracy, and regulatory compliance of Site Visit Reports (SVRs) across assigned clinical studies. This home-based role in Bengaluru is critical to maintaining subject safety, data integrity, and adherence to ICH-GCP guidelines and organizational SOPs.
The position requires strong expertise in clinical monitoring processes, regulatory compliance, and report quality oversight within global clinical trials. The ideal candidate will have prior on-site monitoring experience and the ability to identify risk trends, escalate issues, and support continuous quality improvement initiatives.
Key Responsibilities
Manage and review a caseload of Site Visit Reports (SVRs) for assigned clinical studies.
Ensure compliance with study protocols, GCP guidelines, regulatory requirements, and internal SOPs.
Review SVRs to confirm documentation of corrective and preventive action plans (CAPA) and ensure timely follow-up to resolution.
Identify and escalate site issues, CRA performance gaps, risk factors, and emerging trends to project teams.
Provide guidance to Clinical Project Managers (CPMs) during study start-up and throughout trial execution.
Support quality improvement initiatives including report quality checks, data trending, and issue escalation tracking.
Coach and mentor Clinical Research Associates (CRAs) to reduce report corrections and enhance documentation quality.
Monitor project team compliance with SVR submission timelines and approval workflows.
Participate in cross-functional project meetings to address quality and performance deficiencies.
Support special projects and corporate initiatives related to clinical quality and compliance.
Minimum Qualifications & Experience
Bachelor’s degree in Healthcare, Life Sciences, Pharmacy, Nursing, or related scientific discipline.
7–8 years of clinical research experience, including 3–4 years of on-site monitoring experience as a CRA.
Strong working knowledge of ICH-GCP guidelines, global clinical trial regulations, and regulatory compliance standards.
In-depth understanding of clinical monitoring processes and clinical trial systems/applications.
Experience working on complex, multi-site, or global clinical studies.
Fluency in English (written and spoken).
Core Competencies
Strong analytical and problem-solving skills.
Excellent written and verbal communication abilities.
High attention to detail with strong quality orientation.
Effective time management and ability to manage competing priorities.
Ability to work independently in a remote/home-based environment.
Experience collaborating across global teams and diverse cultural environments.
Ability to build and maintain effective working relationships with CRAs, project managers, and sponsors.
Why This Role Matters
This position plays a key role in safeguarding patient safety, ensuring data reliability, and maintaining regulatory compliance across global clinical trials. By enhancing the quality of Site Visit Reports, the Associate Site Report Specialist directly contributes to the successful delivery of clinical research projects and timely drug development milestones.
Equal Opportunity Statement
The organization is committed to maintaining integrity, transparency, and equal employment opportunity throughout the hiring process. All applications are evaluated based on qualifications, experience, and merit in accordance with applicable laws and regulations.
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