Clinical Trial Associate

The Clinical Trial Associate (CTA) provides essential operational and administrative support to clinical trial teams to ensure the effective planning, execution, and close-out of clinical studies. The role supports Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and project teams in maintaining trial documentation, tracking study progress, and ensuring compliance with ICH-GCP, SOPs, and regulatory requirements.

Key Responsibilities

Trial Management Support

• Support study start-up, conduct, and close-out activities across assigned clinical trials
• Assist CRAs and CTMs with day-to-day trial operations and coordination
• Track study milestones, deliverables, and timelines

Documentation & TMF Management

• Maintain the Trial Master File (TMF) ensuring completeness, accuracy, and inspection readiness
• Collect, review, file, and archive essential study documents
• Support TMF quality checks and reconciliation activities
• Support site initiation, monitoring, and close-out activities
• Track site documents including CVs, training records, regulatory approvals, and essential correspondence
• Coordinate logistics for investigator meetings, monitoring visits, and study materials

Regulatory & Compliance Support

• Assist with regulatory submissions and maintenance of regulatory files
• Ensure documentation complies with ICH-GCP, SOPs, and applicable regulations
• Support audit and inspection readiness activities

Data & System Management

• Update and maintain clinical trial tracking tools and systems (eTMF, CTMS, SharePoint, etc.)
• Support data entry and reconciliation across clinical systems

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field
• 1–3 years of experience in clinical research or clinical trial operations
• Basic understanding of clinical trial processes and ICH-GCP guidelines
• Experience working with eTMF and CTMS systems
• Strong organizational and documentation skills
• Excellent written and verbal communication abilities

Preferred Qualifications

• Experience in CRO or FSP environment
• Exposure to global clinical trials
• Experience supporting Phase I–IV clinical studies
• Familiarity with sponsor-specific SOPs and processes
• Attention to detail and quality focus
• Strong coordination and follow-up skills
• Ability to manage multiple tasks and timelines
• Collaborative team player
• Proficiency in MS Office (Excel, Word, PowerPoint)
• Office-based / hybrid / remote (as applicable)
• May require occasional travel for investigator meetings or training