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Company: Thermo Fisher Scientific Inc.
Job Title: CRA I – FSP (Clinical Research Associate)
Job ID: R-01368661
Location: Mumbai, Maharashtra, India
Work Schedule: Monday to Friday
Work Environment: Office / Clinical Site Monitoring
Experience: 1–2 Years
Qualification: Master’s Degree in Life Sciences (Preferably Pharmacy)
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is a global leader in serving science, providing innovative technologies, pharmaceutical services, and clinical research solutions to support the advancement of healthcare and scientific discovery.
The company is inviting applications for the position of CRA I – FSP (Clinical Research Associate) in Mumbai, Maharashtra.
Job Description
The selected candidate will be responsible for conducting and coordinating clinical monitoring and site management activities. The role involves remote and on-site monitoring visits to ensure clinical trials comply with approved protocols, ICH-GCP guidelines, regulatory requirements, and Standard Operating Procedures (SOPs).
The CRA will work closely with clinical trial sites, sponsors, and internal project teams to maintain data quality, ensure patient safety, and support successful clinical trial execution.
Key Responsibilities
- Conduct on-site and remote clinical monitoring visits using a risk-based monitoring approach.
- Ensure clinical trial sites comply with study protocols, ICH-GCP guidelines, regulatory requirements, and SOPs.
- Perform Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) reviews.
- Identify site-level issues and perform Root Cause Analysis (RCA).
- Recommend and implement corrective and preventive actions (CAPA).
- Review investigational product inventory and related documentation.
- Maintain essential clinical trial documents and ensure audit readiness.
- Conduct site initiation, monitoring, and close-out visits.
- Monitor study progress and maintain accurate records in Clinical Trial Management Systems (CTMS).
- Communicate with investigators, clinical sites, sponsors, and internal project teams.
- Identify compliance issues and escalate them to clinical management.
- Participate in investigator meetings and project-related activities.
- Ensure timely resolution of monitoring findings and documentation discrepancies.
Eligibility Criteria
Educational Qualification
- Master’s degree in a life sciences-related field.
- Pharmacy qualification is preferred.
Experience
- 1–2 years of independent on-site clinical monitoring experience is mandatory.
- Hands-on experience conducting clinical trial site visits across India.
- Experience in monitoring oncology clinical trials is preferred.
Required Skills
- Knowledge of ICH-GCP guidelines and clinical trial regulations.
- Understanding of medical terminology and therapeutic areas.
- Knowledge of Risk-Based Monitoring (RBM).
- Strong analytical, critical-thinking, and problem-solving skills.
- Good written and verbal communication skills.
- Ability to work independently and collaboratively.
- Good organizational and time-management skills.
- Proficiency in Microsoft Office and clinical trial software systems.
- Strong documentation and reporting skills.
Job Location
Mumbai, Maharashtra, India.
How to Apply?
Interested and eligible candidates can apply directly through the official Thermo Fisher Scientific careers portal.
Official Job Application:
https://jobs.thermofisher.com/
OR
Apply Here
Job ID: R-01368661
Candidates are advised to review the official job description and eligibility requirements before submitting their applications.
