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 #J-18808-Ljbffr