Clinical Research Associate (CRA I, CRA II, Senior CRA)
Location: Remote, India
Job ID: R-01326248
Job Type: Full-Time
Category: Clinical Research / Clinical Operations
Work Model: Remote
Clinical Research Associate Jobs in India – Remote Opportunity in Global CRO
A leading global Contract Research Organization (CRO) is hiring Clinical Research Associates (CRA I, CRA II, and Senior CRA) in India to support end-to-end clinical trial monitoring activities across therapeutic areas. This is a full-time remote opportunity for experienced clinical research professionals seeking career growth in global clinical operations.
This role is part of a high-performing clinical research services team delivering innovative solutions across laboratory, digital, and decentralized clinical trials in over 100 countries.
Position Overview
The Clinical Research Associate (CRA) is responsible for overseeing and coordinating all aspects of clinical monitoring and site management activities. The role ensures clinical trials are conducted in compliance with approved protocols, ICH-GCP guidelines, regulatory requirements, and internal SOPs while safeguarding subject safety, data integrity, and audit readiness.
This position supports commercial, government, FSO, and FSP clinical programs across diverse therapeutic areas.
Key Responsibilities
Clinical Monitoring & Site Management
Conduct on-site and remote monitoring visits using a risk-based monitoring (RBM) approach
Perform Source Data Review (SDR), Source Data Verification (SDV), and CRF review
Ensure protocol adherence and regulatory compliance at investigational sites
Perform investigational product accountability and inventory review
Initiate, monitor, and close clinical trial sites in accordance with regulatory requirements
Ensure essential documents are complete per ICH-GCP and applicable regulations
Regulatory & Compliance Oversight
Maintain audit readiness and support regulatory inspections
Escalate site deficiencies and ensure timely resolution
Conduct root cause analysis (RCA) and implement corrective and preventive actions (CAPA)
Maintain study systems including Clinical Trial Management Systems (CTMS)
Stakeholder Communication
Maintain effective communication with investigative sites, sponsors, and project teams
Participate in investigator meetings
Provide trial status updates and progress reports to the Clinical Team Manager (CTM)
Support investigator payment processes
Operational & Administrative Duties
Submit monitoring reports and documentation in compliance with company standards
Complete expense reports and timesheets in a timely manner
Contribute to process improvement initiatives and project documentation
Experience Requirements
CRA Level I
Minimum 2+ years of clinical research experience, including onsite or remote monitoring
Experience in site management and clinical trial compliance
CRA Level II
Minimum 3–5 years of clinical monitoring experience
Demonstrated experience in independent site management and RBM processes
Senior CRA
Minimum 5+ years of clinical monitoring experience
Proven ability to manage complex studies, multiple sites, and mentor junior CRAs
Experience supporting audits and regulatory inspections preferred
Equivalent combinations of education, training, and directly related experience may be considered.
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or a related field
OR
Registered Nurse (RN) certification or equivalent clinical qualification
Required Skills & Competencies
Strong understanding of ICH-GCP, FDA regulations, and applicable global guidelines
Proficiency in Risk-Based Monitoring (RBM) methodologies
Strong clinical and therapeutic area knowledge
Excellent written and verbal communication skills in English
Solid documentation and business writing capabilities
Proficiency in Microsoft Office and clinical trial systems (CTMS, EDC platforms)
Strong critical thinking, root cause analysis, and problem-solving skills
Ability to manage multiple projects under tight timelines
Strong stakeholder management and interpersonal skills
Willingness to travel as required
Work Environment
Remote work model based in India
Ability to work in diverse environments including healthcare or laboratory settings
Travel required as per study allocation
Flexible and performance-driven clinical operations environment
Why Apply?
This opportunity offers clinical research professionals the chance to:
Work on global, multi-country clinical trials
Contribute to life-changing therapies across therapeutic areas
Develop expertise in decentralized and digital clinical trials
Grow within a globally recognized CRO environment
Enhance career progression from CRA I to Senior CRA levels
Keywords for Search Optimization
Clinical Research Associate Jobs India, CRA Remote India, Senior CRA Jobs, CRA I Jobs India, CRA II Careers, Risk-Based Monitoring Jobs, Clinical Monitoring Roles India, ICH-GCP Clinical Research Jobs, CRO Jobs India, Remote Clinical Research Jobs 2026
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