Job Title: Senior Clinical Research Associate (Sr. CRA)
Company: Syngene International Ltd.
Location: Bangalore, India
Department: Clinical Operations – T&CR
Division: Discovery Services
Job Type: Full-Time
Experience Required: 4–7 Years of Clinical Research Experience, including experience as a Clinical Research Associate (CRA)
About Syngene International
Syngene International Ltd. is a leading innovation-driven contract research, development, and manufacturing organization (CRDMO) offering integrated scientific services from early discovery to commercial supply. The company partners with global pharmaceutical, biotechnology, and healthcare organizations to accelerate research and development through high-quality scientific solutions.
Syngene places strong emphasis on safety, regulatory compliance, and operational excellence. The organization promotes a workplace culture focused on environmental health and safety (EHS), quality standards, and ethical scientific practices.
Role Overview
The Senior Clinical Research Associate (Sr. CRA) is responsible for managing and monitoring clinical trial sites to ensure studies are conducted in accordance with study protocols, Good Clinical Practice (GCP) guidelines, regulatory requirements, and company Standard Operating Procedures (SOPs).
This role involves overseeing site performance, conducting monitoring visits, supporting study execution, and ensuring data quality and regulatory compliance throughout the clinical trial lifecycle.
Key Responsibilities
Clinical Trial Site Management
Perform site selection, site initiation, monitoring, and close-out visits according to the study protocol and regulatory guidelines.
Manage assigned clinical trial sites and ensure compliance with study requirements and timelines.
Maintain effective communication with investigators and site staff throughout the study duration.
Study Monitoring and Compliance
Ensure clinical trials are conducted in compliance with Good Clinical Practice (GCP), study protocols, and applicable regulatory requirements.
Monitor site performance and ensure data integrity and patient safety throughout the trial.
Identify and escalate protocol deviations, compliance concerns, or quality issues.
Clinical Trial Documentation and Reporting
Prepare and maintain detailed monitoring visit reports and follow-up letters.
Document monitoring findings and ensure corrective actions are implemented when necessary.
Maintain accurate study documentation and ensure inspection readiness.
Protocol Training and Site Support
Provide protocol-specific training and guidance to investigators and site personnel.
Ensure sites understand protocol requirements, safety reporting procedures, and data collection standards.
Support sites in resolving queries related to study conduct and documentation.
Study Progress and Data Management
Track regulatory and ethics committee submissions and approvals.
Monitor subject recruitment, Case Report Form (CRF) completion, and query resolution.
Ensure timely submission and review of clinical trial data.
Quality Assurance and CAPA Management
Identify quality issues at the site level and work with the Clinical Project Manager to implement corrective and preventive actions (CAPA).
Ensure study activities are conducted in accordance with company quality standards.
Administrative and Project Support
Maintain study-related documentation and tracking systems.
Submit project-related timesheets and support project reporting activities.
Safety and Compliance Requirements
Follow all environmental health and safety (EHS) guidelines and company safety policies.
Ensure completion of mandatory training related to safety, data integrity, and regulatory compliance.
Maintain adherence to Syngene’s quality and compliance standards.
Educational Qualifications
M.Sc., M.Pharm, PharmD, BAMS, BDS, MDS, BHMS, or any relevant Life Sciences degree.
Experience Requirements
4–7 years of experience in clinical research.
Prior experience as a Clinical Research Associate (CRA) or Senior Clinical Research Associate preferred.
Hands-on experience in clinical trial monitoring, site management, and regulatory compliance.
Key Skills and Competencies
Strong understanding of Good Clinical Practice (GCP) guidelines and clinical trial regulations.
Excellent communication and interpersonal skills.
Strong organizational and project management abilities.
Ability to manage multiple clinical trial sites and priorities effectively.
Strong analytical and problem-solving skills.
Ability to work effectively in a fast-paced and dynamic clinical research environment.
Core Values
All employees at Syngene are expected to demonstrate alignment with the organization’s core values:
Excellence
Integrity
Professionalism
Equal Opportunity Employer
Syngene International Ltd. is committed to providing equal employment opportunities to all qualified candidates regardless of race, gender, religion, nationality, disability, or any other protected characteristic. The organization also provides reasonable accommodations for individuals with disabilities in accordance with applicable laws.
Job Location
Bangalore, India.
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