Clinical Research Associate (CRA I, CRA II & Senior CRA)
Job ID: R-01326248
Employment Type: Full-Time
Category: Clinical Research / Clinical Operations
Work Mode: Onsite (India)
Location: India
Work Schedule: Monday to Friday
Job Overview
Thermo Fisher Scientific is hiring Clinical Research Associates (CRA I, CRA II, and Senior CRA) to support global clinical trials across multiple therapeutic areas. As part of the PPD® Clinical Research Services team, you will contribute to high-quality, compliant, and patient-centric clinical studies conducted across more than 100 countries.
This role is ideal for clinical research professionals who are passionate about site management, regulatory compliance, and delivering accurate, audit-ready clinical data in alignment with ICH-GCP and global regulatory standards.
About the Role
Clinical Research Associates play a critical role in ensuring the successful execution of clinical trials from site initiation through close-out. You will work closely with investigative sites, sponsors, and internal project teams to ensure protocol adherence, subject safety, and data integrity throughout the trial lifecycle.
Key Responsibilities
Perform and coordinate all aspects of clinical monitoring and site management
Conduct onsite and remote monitoring visits in accordance with the approved monitoring plan
Ensure compliance with study protocols, ICH-GCP guidelines, applicable regulations, and SOPs
Apply risk-based monitoring principles, root cause analysis, and corrective/preventive actions
Perform Source Data Review (SDR), Source Data Verification (SDV), and CRF review
Review investigational product accountability, storage, and inventory records
Document monitoring activities, findings, follow-ups, and correspondence in a timely manner
Escalate issues, risks, and deviations to Clinical Management and ensure resolution
Support site initiation, routine monitoring, and study close-out activities
Ensure essential trial documentation is complete, accurate, and inspection-ready
Maintain study systems such as Clinical Trial Management Systems (CTMS)
Facilitate effective communication between sites, sponsors, and project teams
Participate in investigator meetings and support site feasibility activities
Respond to audits, inspections, and regulatory inquiries
Complete administrative tasks including timesheets and expense reports
Contribute to continuous improvement initiatives and project deliverables
Experience & Qualification Requirements
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field
Registered Nursing certification or equivalent qualification may be considered
Experience by Level:
CRA I: Minimum 2+ years of onsite clinical monitoring experience
CRA II: Typically 3–5 years of independent clinical monitoring experience
Senior CRA: Typically 5+ years of end-to-end clinical monitoring experience, including mentoring and site oversight
Equivalent combinations of education, training, and relevant experience may be considered.
Required Knowledge, Skills & Competencies
Proven experience in clinical monitoring and site management
Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes
Experience with risk-based monitoring methodologies
Ability to perform root cause analysis and implement corrective actions
Strong knowledge of medical terminology and therapeutic areas
Excellent written and verbal communication skills
Strong organizational, time management, and documentation skills
High attention to detail and quality standards
Ability to work independently and within cross-functional teams
Proficiency in Microsoft Office and clinical trial systems
Strong command of English language and professional business writing
Work Environment & Travel
Office and clinical site-based work environment
Ability to work in non-traditional and regulated environments
Independent travel required, including domestic travel by road, rail, and air
Ability to manage multiple priorities and perform effectively under pressure
Why Join Thermo Fisher Scientific
Work on global, high-impact clinical trials across diverse therapeutic areas
Be part of the PPD® Clinical Research portfolio within a leading global CRO
Access continuous learning, professional development, and career progression
Collaborate with global clinical operations teams and leading biopharma sponsors
Contribute to life-changing therapies that improve global health outcomes
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is a global leader in serving science, with annual revenue exceeding $44 billion. With over 90,000 employees worldwide, the company enables customers to make the world healthier, cleaner, and safer through innovative technologies, pharmaceutical services, and clinical research solutions.
Thermo Fisher Scientific is an Equal Employment Opportunity Employer and is committed to diversity, equity, and inclusion.
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