PHARMAFull-time
CRA I - FSP
By Admin · Clinical Research & Clinical Operations
MUMBAI (IN)REMOTEPOSTED: 9/21/2026
PHARMAFull-time
HIRING ORGANIZATIONTHERMO FISHER SCIENTIFICLife Sciences / Scientific Instruments / Biotechnology
ROLE OVERVIEW
Clinical Research Associate I role supporting clinical trial monitoring and site management in a fully remote position, with responsibility for protocol compliance, data quality, site relationships, documentation and audit readiness.
ROLE DEFINITION & RESPONSIBILITIES
- •Monitor investigator sites using risk-based monitoring
- •identify site process failures and implement corrective and preventive actions
- •conduct source data review, source data verification and CRF review
- •assess investigational product inventory and records
- •document observations and escalate deficiencies
- •maintain regular communication with investigative sites
- •conduct site initiation and close-out activities
- •ensure essential documents meet ICH-GCP and regulatory requirements
- •participate in investigator payments and meetings
- •track trial status and provide project updates
- •maintain CTMS and other study systems
- •facilitate communication between sites, clients and internal project teams
- •respond to audits and inspections
- •complete administrative documentation
- •contribute to project publications, tools and process-improvement initiatives
Reporting Hierarchy: Receives detailed instructions and works under an immediate supervisor; primary relationships include the clinical operations department, investigative sites, client companies and internal project teams
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master's degree in a life sciences-related field, preferably Pharmacy
- 1-2 years of independent onsite clinical monitoring experience
- hands-on experience conducting clinical trial site visits across India
- working knowledge of ICH-GCP and applicable regulations
- ability to communicate effectively with medical personnel
- strong organizational, interpersonal and critical-thinking skills
PREFERRED QUALIFICATIONS
- •Oncology clinical trial monitoring experience
- •experience with risk-based monitoring concepts
- •experience with CTMS and clinical trial software
- •strong Microsoft Office skills
REQUIRED VERIFIED SKILLS
clinical monitoring
site management
ICH-GCP
regulatory compliance
risk-based monitoring
source data review
source data verification
CRF review
CTMS
clinical trial documentation
root cause analysis
corrective and preventive actions
audit readiness
medical terminology
Microsoft Office
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Standard benefits and professional development opportunities; remote working arrangement
No salary or bonus/equity information is disclosed in the supplied posting.
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific provides products, services and solutions supporting scientific research, clinical development, diagnostics and healthcare.
TEAM SIZE: Large multinational organization
INDUSTRY: Life Sciences / Scientific Instruments / Biotechnology
Culture: Process-driven, collaborative and compliance-focused environment emphasizing data quality, patient rights, critical thinking and customer focus.
EXPECTED CAREER ROADMAP
Potential progression within clinical operations toward Clinical Research Associate II, Senior CRA, Lead CRA or clinical project-management roles, subject to performance and organizational opportunities.
APPLICATION ADVISORY
Highlight the required Master's degree, 1-2 years independent onsite monitoring experience, India-wide site visit experience, ICH-GCP knowledge, risk-based monitoring, critical thinking and willingness to travel extensively.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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