Senior Clinical Research Associate (CRA)

About the role

The Senior Clinical Research Associate (CRA) will lead monitoring activities for Phase I‑IV clinical studies and Real‑World Evidence projects. You will ensure compliance with ICH, Good Clinical Practice (GCP) and all applicable regulations while supporting site management and study execution.

Key responsibilities

• Serve as the primary CTI contact for assigned study sites and conduct site visits (pre‑study, initiation, interim monitoring, close‑out) according to the Monitoring Plan.
• Oversee study start‑up activities, including feasibility assessments, pre‑study documentation, and site selection.
• Manage regulatory and essential documents, investigational product (IP) storage, dispensation, and accountability.
• Perform remote monitoring, source data verification (SDV), and track subject status using study systems.
• Develop and implement subject enrollment strategies and maintain ISF/TMF compliance.
• Support contract negotiations, investigator payments, and coordinate with Clinical Data Management for data cleaning.
• Mentor junior CRAs and provide training or assessment visits as needed.
• Assist Regulatory Affairs with ethics committee submissions and follow‑up until approval.

Required profile

• Extensive experience in clinical monitoring across multiple study phases.
• Strong knowledge of ICH guidelines, GCP, and regulatory requirements.
• Proven ability to manage site relationships and resolve issues proactively.
• Excellent organizational skills and attention to detail.

Required skills

• ICH/GCP compliance
• Regulatory document management
• Site monitoring (PSV, SIV, IMV, COV)
• Investigational Product (IP) handling
• Case Report Form (CRF) and Source Data Verification (SDV)
• Trial Master File (TMF) / Investigator Site File (ISF) management
• Contract negotiation and investigator payment processing
• Data cleaning coordination with Clinical Data Management