Clinical Trial Associate
hace 2 días
Paramus
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 Site & Vendor Coordination • 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 Key Competencies • 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) Work Environment • Office-based / hybrid / remote (as applicable), • May require occasional travel for investigator meetings or training