Thermo Fisher Scientific Hiring Clinical Research Associate I (FSP)

Thermo Fisher Scientific Inc. is inviting applications for the position of Clinical Research Associate I (CRA I – FSP) based out of Mumbai, Maharashtra.

The role focuses on risk-based clinical trial monitoring, investigative site management, and maintaining protocol and ICH-GCP compliance across clinical trial locations in India.

Key Job Details

Designation: CRA I – FSP (Clinical Research Associate I)
Company: Thermo Fisher Scientific
Experience Required: 1 to 2 years of independent on-site clinical monitoring experience
Location: Mumbai, Maharashtra
Education: Master’s degree in Life Sciences (preferably Pharmacy / M.Pharm)
Industry Sector: Pharma / Healthcare / Clinical Research
Travel Expectation: Regular site travel (may exceed 75%)
Application Deadline: 20 October 2026

Core Responsibilities

Site Monitoring & Oversight: Conduct remote and on-site visits across India utilizing a risk-based monitoring framework to verify protocol adherence and trial progress.
Data Verification & Review: Ensure study data accuracy via Source Data Verification (SDV), Source Data Review (SDR), and Case Report Form (CRF) cross-checks.
Problem Resolution & Compliance: Apply root cause analysis (RCA) and critical thinking to identify site process deficiencies and implement Corrective and Preventive Actions (CAPA).
Trial Lifecycle Support: Assist in site qualification, site initiation, ongoing site management, investigational product (IP) inventory reconciliation, and final close-out visits.
Documentation & Systems: Document monitoring visit reports and follow-up letters in compliance with business writing standards; maintain up-to-date trial status across CTMS and related study platforms.
Communication & Collaboration: Maintain consistent communication with investigators, site study staff, sponsor teams, and internal project managers.

Candidate Profile & Qualifications

Education: Master’s degree in Pharmacy (M.Pharm) or related Life Sciences discipline.
Experience: Mandatory 1 to 2 years of independent, hands-on clinical monitoring experience conducting study visits across India. Oncology trial monitoring experience is an added advantage.
Competencies & Skills:
- Solid working foundation in ICH-GCP guidelines, local regulatory frameworks, and study SOPs.
- In-depth understanding of medical terminology and therapeutic concepts.
- Strong critical-thinking, investigative mindset, and detail orientation.
- Fluent professional verbal and written English communication skills.
- Proficiency in MS Office and specialized clinical trial management platforms.