Overview
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KPS Life is looking to recruit CTA - sponsor dedicated, fixed term contract, 1 FTE, remote.
The Clinical Trial Associate (CTA) plays a vital role in supporting the Clinical Study Team (CST) to ensure the successful execution of clinical trials across all phases. This position focuses on operational excellence, documentation management, and cross-functional collaboration, ensuring compliance with FDA regulations, ICH/GCP guidelines, and internal SOPs.
Responsibilities
Coordinate and support study start-up, maintenance, and close-out activities
Ensure adherence to protocols, SOPs, and regulatory requirements
Participate in risk assessment and mitigation planning using RACT tools
Documentation & TMF Management
Maintain Trial Master File (TMF), both paper and electronic (eTMF), including Veeva
Perform quality control checks and prepare TMF Health Reports
Track essential documents and training records for CST and sites
Vendor & CRO Coordination
Collaborate with CROs and vendors to ensure timely and quality deliverables
Review SOPs, contracts, work orders, and invoices
Support inspection readiness and audit preparation
Team Collaboration
Schedule and manage CST meetings, agendas, and action items
Track protocol deviations and provide regular updates
Qualifications & Skills
Bachelor’s degree in Life Sciences, Healthcare, or related field
Minimum 3+ years of experience in Clinical Operations (biotech, xpzdshu pharma, CRO, ARO)
Experience in rare disease/orphan indications preferred
Strong knowledge of FDA regulations, ICH/GCP guidelines, and clinical trial processes
Proficiency with TMF systems (especially Veeva) and DIA TMF Reference Model
Excellent communication, organization, and problem-solving skills
Ability to work proactively and cross-functionally in a global team environment
Additional Information
Travel: Up to 10% (domestic/international)
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