Inhouse Clinical Research Associate (IHCRA)

Role & Responsibilities
• Provide in-house clinical support to the study team as per project requirements
• Ensure compliance with ICH GCP, regulatory requirements, and SOPs
• Coordinate, maintain, and quality-check Trial Master File (TMF) documentation
• Track essential documents and support internal and external audits
• Perform routine QC reviews and final TMF reconciliation
• Support development, collection, and management of essential documents as per Good Documentation Practice
• Manage and update Clinical Trial Management System (CTMS) data
• Maintain site compliance scores, milestones, subject tracking, and PISCFs
• Create Investigator Site Files (ISF) and manage trial material logistics
• Coordinate ordering, dispatch, tracking, and storage of study materials
• Maintain stock reports and ensure safe storage of trial supplies

Qualification
• Degree in Life Sciences or related field
• Candidates with administrative or healthcare background may also be considered

Experience
• 1 – 2 years of experience as an Inhouse CRA or in a relevant clinical research role
• Experience in pharmaceutical, CRO, or healthcare industry preferred

Skills
• Strong understanding of ICH GCP and clinical trial documentation
• TMF and CTMS management expertise
• High attention to detail and documentation accuracy
• Good coordination and communication skills
• Ability to manage multiple tasks and timelines

About the Company
• Novotech is a leading global CRO Provides clinical trial services across multiple therapeutic areas Known for strong regulatory compliance and quality-driven research operations.