Senior Clinical Trial Associate (Sr. CTA)

Senior Clinical Trial Associate to independently manage trial master files, coordinate with CROs, and mentor junior staff at a clinical-stage biotech company. Lead TMF integrity, document development, and clinical supply coordination with minimal oversight.

Responsibilities

• Own study TMF plan development, tracking, and archiving of essential documents throughout trial lifecycle
• Lead quality reviews of TMF and resolve discrepancies directly with CRO partners
• Draft and finalize study documents including protocols, manuals, CRFs, and patient materials
• Independently manage clinical supply and lab sample coordination, identifying risks proactively
• Mentor junior CTAs and contribute to training materials and SOPs for the broader team

Requirements

• Bachelor's degree in science-related field or equivalent education and work experience
• 3–5+ years of clinical operations or clinical research experience
• Demonstrated end-to-end ownership of TMF or vendor relationship management
• Ability to resolve routine CRO and vendor issues independently
• Experience mentoring or guiding junior team members
• Strong verbal and written communication skills
• Proficiency with MS Word, Excel, Outlook, and PowerPoint

Compensation: $134,500–$146,600 annually