Senior Clinical Trial Associate

Role Summary

The Senior CTA plays a critical role in the execution of Phase 1–3 clinical trials and is responsible for ensuring operational excellence, inspection readiness, and compliance with ICH/GCP guidelines and company SOPs. This position partners closely with Clinical Trial Managers, CROs, vendors, and investigative sites to support timely and high-quality study delivery.

Responsibilities

• Independently support and coordinate clinical trial activities from start-up through close-out.
• Partner with CTMs to ensure operational milestones, timelines, and deliverables are achieved.
• Serve as primary owner of Trial Master File (TMF) quality, completeness, and inspection readiness.
• Perform ongoing TMF quality control and resolve documentation gaps with internal teams and vendors.
• Collaborate with CROs, vendors, and sites to ensure study milestones and deliverables are met.
• Track study timelines, identify risks, and proactively escalate issues as needed.
• Support IRB/IEC submissions and review essential regulatory documents for compliance.
• Maintain accurate and timely data within clinical systems (eTMF, CTMS, EDC).
• Assist with development and review of key clinical documents, including protocols, informed consent forms and study plans/manuals.
• Support preparation, review, and tracking of IRB/IEC submissions and regulatory documentation.
• Coordinate and track laboratory samples from investigative sites to central and specialty laboratories, ensuring timely shipment, reconciliation, and documentation accuracy.
• Participate in internal and external meetings, including preparation of agendas, meeting minutes, and action item tracking.
• Prepare and manage study communications, including newsletters and study updates as needed.
• Contribute to audit and inspection preparation activities.

Qualifications

• Preferred: Bachelor’s degree in a scientific or healthcare-related field; equivalent experience considered.
• Required: 2-3+ years of clinical operations experience in biotechnology, pharmaceutical, or CRO settings.
• Required: Experience supporting Phase 1–3 clinical trials.
• Required: Hands-on experience with TMF management and clinical systems (eTMF, CTMS, EDC).
• Required: Working knowledge of ICH/GCP and applicable regulatory requirements.
• Required: Strong organizational skills and exceptional attention to detail.
• Required: Ability to manage multiple priorities in a fast-paced, collaborative environment.
• Required: Excellent written and verbal communication skills.
• Preferred: Experience in a small or early-stage biotech company.
• Preferred: Experience supporting audit or regulatory inspection readiness.
• Preferred: Experience working with global or multi-site clinical trials.
• Preferred: Prior CRO oversight experience.