Clinical Trial Assistant (CTA)

Role Summary

The Clinical Trial Assistant (CTA) provides administrative support to the Clinical Operations Team across the full spectrum of clinical trial activities, including study start-up, maintenance, closure, and vendor management. This role ensures compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and applicable regulations governing clinical trials.

Responsibilities

• Assist with review, formatting and finalizing clinical protocols and other key study documents such as reports, Study Master ICF Template, etc.
• Provide administrative support with various tasks such as review and formatting of documents including follow-up on various tasks, updating project timelines, etc.
• Perform other duties as required.

Qualifications

• Required: Bachelor’s Degree in a related field.
• Preferred: minimum of one-year relevant clinical trial experience in the pharmaceutical and/or biotechnology industry.
• Preferred: prior experience as a CTA and/or knowledge of FDA, ICH, GCP, CFR guidelines, regulatory requirements and clinical trials operations.

Skills

• The scope of this position requires strong organizational, communication, and administrative skills including proficiency in Microsoft Office Suite such as Word, Excel, PowerPoint.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
• Requires good organization, documentation and interpersonal skills.
• Ability to work independently as well as within a team-oriented environment.
• Strong attention to detail.