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1-3 years
₹7 – ₹12 LPA
10 July 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science/Registered Nurse Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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