Clinical Research Associate (CRA I, CRA II & Senior CRA) – Clinical Operations
Job ID: R-01326248
Location: Remote, India (Onsite Monitoring Travel Required)
Employment Type: Full Time
Category: Clinical Research
Work Schedule: Monday to Friday
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Job Overview
ThePharmaDaily.com is featuring multiple openings for Clinical Research Associates (CRA I, CRA II, and Senior CRA) within Clinical Operations at Thermo Fisher Scientific’s PPD clinical research portfolio. This opportunity is ideal for clinical monitoring professionals seeking career growth within a leading global Contract Research Organization (CRO).
The CRA will be responsible for site management, monitoring oversight, regulatory compliance, and ensuring data integrity across clinical trials conducted in accordance with ICH-GCP guidelines and applicable regulatory requirements. This role supports commercial, government, and sponsor-dedicated projects across therapeutic areas.
Experience Level
CRA I – Entry to Mid-Level
CRA II – Mid-Level
Senior CRA – Experienced / Senior Level
Experience Required:
CRA I: Minimum 2+ years of onsite clinical monitoring experience.
CRA II: Typically 3–5 years of clinical research monitoring experience.
Senior CRA: 5+ years of monitoring experience with advanced site management expertise.
Equivalent combinations of education, training, and relevant clinical research experience may be considered.
Key Responsibilities
Clinical Trial Monitoring & Site Management
Conduct on-site and remote monitoring visits using a Risk-Based Monitoring (RBM) approach.
Ensure compliance with study protocols, ICH-GCP, SOPs, and regulatory requirements.
Perform Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).
Maintain audit readiness and ensure essential documents are complete and accurate.
Data Verification & Quality Oversight
Perform Source Data Verification (SDV), Source Data Review (SDR), and CRF review.
Identify protocol deviations, compliance gaps, and site process failures.
Apply root cause analysis (RCA) and implement corrective/preventive actions (CAPA).
Investigational Product Accountability
Review investigational product storage, accountability logs, and inventory records.
Ensure proper documentation and compliance with regulatory standards.
Stakeholder Communication & Collaboration
Maintain regular communication with investigative sites and sponsor teams.
Provide trial status updates to Clinical Team Managers (CTM).
Facilitate collaboration between sites, sponsors, and project teams.
Regulatory & Inspection Readiness
Support audits and regulatory inspections.
Ensure adherence to applicable health authority regulations and internal SOPs.
Clinical Systems & Documentation
Update Clinical Trial Management Systems (CTMS) and maintain accurate documentation.
Prepare monitoring reports and follow-up letters in accordance with company standards.
Educational Qualifications
Bachelor’s degree in Life Sciences or related healthcare discipline; OR
Registered Nursing certification; OR
Equivalent academic/vocational qualification in clinical research.
Valid driver’s license may be required depending on travel demands.
Required Skills and Competencies
Strong knowledge of ICH-GCP and global regulatory requirements.
Proven clinical monitoring and site management expertise.
Understanding of therapeutic area knowledge and medical terminology.
Risk-Based Monitoring (RBM) knowledge and application experience.
Strong critical thinking and problem-solving skills.
Excellent written and verbal communication skills in English.
Ability to manage multiple priorities in dynamic clinical environments.
Proficiency in Microsoft Office and clinical trial management systems.
Strong organizational and interpersonal skills.
Work Environment & Travel
Remote-based role with travel requirements for on-site monitoring visits.
Exposure to healthcare and clinical site environments.
Ability to manage independent travel via air, rail, or road as required by study allocation.
Why Consider This Role
Opportunity to work on global clinical trials across 100+ countries.
Exposure to decentralized, digital, and traditional clinical trial models.
Career progression within one of the world’s leading CRO organizations.
Involvement in innovative research that contributes to improved global health outcomes.
About Thermo Fisher Scientific – PPD Clinical Research Services
Thermo Fisher Scientific is a global leader in life sciences solutions, supporting clinical development, laboratory services, and healthcare innovation. Through its PPD clinical research portfolio, the organization delivers comprehensive CRO services across the drug development lifecycle.
SEO Keywords
CRA Jobs India Remote, Clinical Research Associate India, Senior CRA Jobs 2026, Clinical Monitoring Careers, CRO Jobs India, Risk Based Monitoring CRA, Site Monitoring Specialist India, PPD Clinical Research Careers.
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