Clinical Research Associate (CRA) - Level II
Location: Mumbai, Maharashtra, India (Fully Remote)
Job ID: R-01321868
Job Type: Full-time
Department: Clinical Research
Shift: Standard (Monday to Friday)
Estimated Salary: ₹7 – ₹12 LPA (based on industry standards for CRA-II roles in India)
Role Summary:
Thermo Fisher Scientific’s PPD® clinical research division is looking for a CRA Level II to manage site monitoring activities for ongoing clinical trials. This remote-based role will be responsible for ensuring protocol compliance, ICH-GCP standards, and regulatory adherence through routine and risk-based monitoring strategies. You'll collaborate closely with investigative sites and internal project teams to ensure accurate data collection and patient safety.
Key Responsibilities:
Conduct on-site and remote monitoring activities, including SDR (Source Data Review), SDV (Source Data Verification), and CRF review
Apply root cause analysis (RCA) and critical thinking to resolve site process failures
Track investigational product inventory and perform document verification
Create timely visit reports and follow up on site issues to resolution
Participate in site initiation, routine monitoring, and trial closeout visits
Collaborate with clinical project teams to manage documentation, updates, and issue escalation
Ensure completeness of essential regulatory documents in alignment with ICH-GCP
Support investigator meetings, payments, site feasibility assessments, and site contracting
Maintain accurate records in CTMS and respond effectively to audits or inspections
Contribute to process improvements and project tools/documents as required
Qualifications & Experience:
Bachelor’s degree in Life Sciences, Nursing, or equivalent vocational qualification
1–3 years of on-site monitoring experience as a CRA in the clinical trials domain
Experience in conducting site visits and managing trial documentation
Strong familiarity with GCP, local regulations, and clinical monitoring practices
Key Skills:
Clinical trial monitoring expertise with working knowledge of ICH-GCP
Excellent communication and interpersonal skills
Strong organizational, documentation, and time-management capabilities
Familiarity with Risk-Based Monitoring (RBM) practices
Detail-oriented with analytical and problem-solving skills
Ability to remain adaptable and collaborative across multifunctional teams
Why Join Thermo Fisher Scientific?
Work with a leading global CRO delivering life-changing therapies
Flexible fully remote work setup
Access to learning programs and internal career progression pathways
A mission-focused team working toward a healthier, cleaner, and safer world
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