Overview
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, 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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