Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance

Clinical Research Associate II (CRA II) – Fortrea

Location

Bangalore, India

Job Type

Full time

Experience Required

2–5 years of Clinical Monitoring experience in Clinical Research, CRO, or Pharmaceutical organizations.
Ability to independently monitor clinical study sites according to ICH-GCP guidelines and project requirements.

Estimated Salary Package (Market Standard)

₹9 – ₹15 LPA (approx.), depending on experience, therapeutic area expertise, and interview performance.

Job Overview

The Clinical Research Associate II (CRA II) is responsible for independently monitoring clinical trial sites to ensure compliance with study protocols, ICH-GCP guidelines, sponsor requirements, and regulatory standards. The role includes site management, monitoring visits, source data verification, regulatory documentation, investigational product accountability,



and ensuring patient safety throughout the clinical trial lifecycle.

Key Responsibilities

Clinical Site Monitoring

Conduct Pre-Study, Site Initiation, Routine Monitoring, Interim, and Close-Out Visits.
Manage assigned clinical study sites according to SOPs, ICH-GCP guidelines, and sponsor requirements.
Prepare and implement monitoring plans.
Verify study training records and site readiness.
Ensure audit and inspection readiness at study sites.

Clinical Data & Compliance

Perform Source Data Verification (SDV) and source document review.
Review eCRFs and resolve clinical data queries.
Identify protocol deviations and ensure corrective actions are implemented.
Ensure data integrity, accuracy, completeness, and regulatory compliance.
Maintain current and accurate regulatory documentation in eTMF and sponsor systems.

Patient Safety & Study Conduct

Verify informed consent procedures before patient enrollment.

📌 Clinical Research Associate II (Bengaluru)
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