Global clinical research organization Fortrea has announced a new opening for the position of Clinical Research Associate II (CRA II) in Bangalore. This opportunity is ideal for professionals with clinical monitoring experience who want to advance their career in clinical operations, site management, and trial monitoring within the pharmaceutical and biotechnology industry.

Candidates with strong knowledge of ICH-GCP guidelines, clinical trial monitoring, SAE reporting, eCRF review, CTMS systems, and site management are encouraged to apply. The role involves extensive interaction with investigators, sponsors, and clinical trial sites while ensuring compliance, subject safety, and data integrity.

About Fortrea

Fortrea is a leading global contract research organization (CRO) providing clinical development, patient access, and technology solutions to pharmaceutical, biotechnology, and medical device companies worldwide. The organization supports clinical trials across multiple therapeutic areas and phases of development.

Clinical Research Associate II Job Overview

Key Responsibilities of Clinical Research Associate II

The selected candidate will perform site monitoring and clinical operations activities according to Fortrea SOPs, ICH-GCP guidelines, and sponsor requirements.

Major responsibilities include:

• Conduct site initiation, routine monitoring, process monitoring, and close-out visits
• Verify informed consent procedures and protocol compliance
• Perform source document verification (SDV) and eCRF review
• Generate and resolve data queries in clinical trial systems
• Ensure study subject safety and data integrity
• Maintain site regulatory documentation and eTMF compliance
• Track investigational product (IP) accountability and storage
• Ensure audit readiness at clinical trial sites
• Support SAE reporting and follow-up activities
• Collaborate with study teams to meet clinical trial timelines
• Prepare monitoring reports and site management documentation
• Train site staff and support investigator meetings
• Work with CTMS and other eClinical systems

Required Qualifications

Candidates applying for this Clinical Research Associate II job in Bangalore should possess:

• University degree in Life Sciences, Pharmacy, Nursing, or Allied Health Sciences
• OR equivalent clinical research experience
• Thorough understanding of ICH-GCP guidelines
• Knowledge of local regulatory requirements
• Strong understanding of clinical monitoring procedures
• Good communication skills in English
• Ability to work independently with minimal supervision
• Strong organizational and analytical skills

Experience Required

External Candidates

• Minimum 2 years of clinical monitoring experience

Preferred Experience

• Phase I clinical trial monitoring
• SAE processing and narrative writing
• CTMS and eClinical systems usage
• Experience in pharmaceutical, CRO, clinical operations, or research environments

Important Skills for CRA II Role

• Clinical site monitoring
• Source data verification (SDV)
• eCRF review
• Query management
• Clinical trial management systems (CTMS)
• Site management
• Regulatory documentation
• SAE reporting
• GCP compliance
• Communication and negotiation skills

Salary and Benefits

Based on industry standards for Clinical Research Associate II jobs in Bangalore, the expected salary may range between:

₹8 LPA – ₹14 LPA (Estimated)

Additional benefits may include:

• Global clinical research exposure
• Career growth opportunities
• Training and development programs
• Travel allowances
• Work with multinational sponsors
• Exposure to Phase I-IV clinical trials

Who Should Apply?

This role is suitable for:

• Clinical Research Associates (CRA)
• Clinical Trial Monitors
• Clinical Operations professionals
• Pharmacists with CRA experience
• Life Science graduates with monitoring background
• Nurses transitioning into clinical research

How to Apply

Application Link