Senior Clinical Trial Associate

Senior Clinical Trial Associate Overview

• The Senior Clinical Trial Associate (Sr. CTA) will support late-stage cardiovascular clinical programs, collaborating with trial-specific operations teams to ensure deliverables are met.
• This remote contract role involves assisting with clinical study management and execution, ensuring compliance with regulations, SOPs, and ICH-GCP guidelines.
• Contribute to innovative treatments for unmet cardiovascular disease needs, working closely with Clinical Trial and Program Leads.
• Coordinate trial-related activities, from startup through database lock, ensuring protocol and SOP compliance.
• Collaborate across internal and external teams, supporting meetings, vendor oversight, and budget management.
• Prepare, edit, and track clinical documents, including protocols, Investigator’s Brochures, and informed consents.
• Manage Trial Master File reviews, ensuring quality and compliance throughout the study lifecycle.
• Support registry updates and system tracking for study-related information, ensuring accurate and timely submissions.
• Assist with Investigator Meeting planning and development of study-related presentations and reports.

Senior Clinical Trial Associate Key Responsibilities & Duties

• Coordinate trial activities, ensuring compliance with protocols, SOPs, and regulatory guidelines throughout the study lifecycle.
• Capture and follow up on meeting decisions and action items to ensure timely completion.
• Oversee CROs and third-party vendors, ensuring study requirements and timelines are met effectively.
• Review vendor invoices for accuracy and track payments against the budget.
• Prepare, edit, and route clinical documents, including protocols and informed consents, ensuring quality and compliance.
• Support the review of CRFs, study guides, and forms, participating in specification processes and user acceptance testing.
• Perform periodic reviews and QC of Trial Master Files, ensuring sponsor expectations are met.
• Coordinate essential document reviews for site activation, collaborating with CROs and other functions.
• Assist with the development of presentations, reports, and study-related materials, supporting program leads.

Senior Clinical Trial Associate Job Requirements

• Bachelor’s degree in life sciences or healthcare-related discipline required.
• Minimum 4 years of clinical research support experience in pharmaceutical, biotechnology, or related environments.
• Strong knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• Proficiency in Microsoft PowerPoint, Excel, Word, and Smartsheet.
• Experience with Trial Master Files, performing periodic reviews and audits for quality assurance.
• Ability to work independently and collaboratively in fast-paced environments.
• Excellent organizational, planning, and time management skills, with the ability to prioritize multiple projects.
• Analytical thinker with problem-solving skills and adaptability to changing priorities.
• Experience interacting and collaborating with CROs and vendors, ensuring quality and compliance.