Thermo Fisher Scientific is recruiting for the position of Clinical Research Associate I (CRA I) – FSP in Mumbai, India. This is a full-time, fully remote position focused on clinical trial monitoring, investigational site management, regulatory compliance, and clinical data quality.
Candidates with a master’s degree in a life sciences-related field, preferably Pharmacy, and independent on-site clinical monitoring experience can apply.
Thermo Fisher Scientific Recruitment 2026 – Job Details
| Particulars | Details |
|---|---|
| Company | Thermo Fisher Scientific |
| Job Title | CRA I – FSP |
| Job Requisition ID | R-01368661 |
| Location | Mumbai, India |
| Work Mode | Fully Remote |
| Job Type | Full-time |
| Work Schedule | Monday–Friday |
| Qualification | Master’s degree in a life sciences-related field, preferably Pharmacy |
| Experience | 1–2 years of independent on-site clinical monitoring experience |
| Application Mode | Online |
Position Overview
The Clinical Research Associate I will coordinate clinical monitoring and site management activities to ensure clinical trials comply with approved protocols, ICH-GCP guidelines, applicable regulations, and standard operating procedures.
The role includes monitoring investigator sites, maintaining essential trial documentation, identifying compliance issues, and supporting clinical trial progress and audit readiness.
Roles and Responsibilities
- Monitor investigator sites using a risk-based monitoring approach.
- Conduct on-site and remote monitoring activities to assess protocol and regulatory compliance.
- Perform Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) reviews, as applicable.
- Identify site process failures and support corrective and preventive actions through root cause analysis.
- Review investigational product inventory and associated records.
- Document monitoring observations and escalate compliance issues to clinical management.
- Maintain regular communication with investigative sites to support protocol compliance and timely data recording.
- Ensure essential trial documents meet ICH-GCP and regulatory requirements.
- Support clinical trial site initiation and close-out activities.
- Update the Clinical Trial Management System (CTMS) and maintain accurate study records.
- Track trial progress and provide status updates to project teams.
- Coordinate with investigative sites, sponsors, and internal project teams.
- Support audits, inspections, investigator meetings, and project improvement initiatives.
Eligibility Criteria and Qualifications
- Master’s degree in a life sciences-related field, preferably Pharmacy.
- 1–2 years of independent on-site clinical monitoring experience.
- Hands-on experience conducting clinical trial site visits across India.
- Experience monitoring oncology trials is preferred.
Required Skills
- Basic medical and therapeutic-area knowledge.
- Understanding of medical terminology.
- Knowledge of ICH-GCP requirements and applicable regulations.
- Strong written and verbal communication skills in English.
- Ability to communicate effectively with medical personnel.
- Good organizational and time-management skills.
- Critical thinking, root cause analysis, and problem-solving abilities.
- Understanding of risk-based monitoring concepts and processes.
- Proficiency in Microsoft Office and the ability to use relevant software systems.
- Ability to work independently and collaboratively.
How to Apply
