Clinical Trial Associate

Roles & Responsibilities
• Provide operational and administrative support to Project Managers, CRAs, and study teams
• Support safety reporting and data management activities
• Track, analyze, and report KPIs; identify risks and suggest corrective actions
• Maintain and update CTMS, TMF, and study trackers to ensure audit readiness
• Track incoming and outgoing clinical and regulatory documents
• Support TMF reviews and follow up on missing or incomplete documentation
• Coordinate project-specific trainings and ensure training compliance
• Maintain study correspondence, meeting minutes, and action item trackers
• Interact with investigators for essential document collection
• Support internal and external audits and regulatory inspections
• Prepare and maintain ISF (Investigator Site File) and site manuals
• Coordinate ordering, shipment, and tracking of site supplies
• Support feasibility activities including CDA and feasibility questionnaires

Qualification
• B.Sc (Biochemistry / Biotechnology / Bioinformatics / MLT)
• B.Pharm (Any specialization)
• B.Tech / B.E. (Biotechnology / Biomedical / Bioinformatics)

Experience
• Candidates with relevant clinical research or trial operations experience preferred

Skills
• Clinical trial operations knowledge
• Hands-on experience with TMF, CTMS, and regulatory documentation
• Understanding of GCP and ICH guidelines
• Strong communication, coordination, and organizational skills
• Good documentation and tracking abilities

About the Organization
Agati Systems is a growing clinical research and life sciences organization providing end-to-end clinical operations and support services, enabling efficient, compliant, and high-quality clinical trial execution across therapeutic areas.