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21 CFR Part 11•GDPR•ICH-GCP•Admin

Clinical Operations

Senior Clinical Research Associate (CRA)

Lead on-site and remote monitoring across Phase I–IV trials, ensuring ICH-GCP compliance and pristine data integrity.

Clinical Operations New Delhi, IndiaFull-time5+ years

Responsibilities

Conduct site initiation, monitoring and close-out visits across therapeutic areas.
Ensure adherence to ICH-GCP, 21 CFR Part 11 and internal SOPs.
Manage source data verification and query resolution.
Mentor junior CRAs and support risk-based monitoring strategy.

Requirements

Bachelor's/Master's in Life Sciences, Pharmacy or Medicine.
5+ years CRA experience with multi-site trial exposure.
Deep knowledge of ICH-GCP and global regulatory frameworks.
Willingness to travel up to 60%.

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