Job Title: Contract Sr. Clinical Trial Associate (Sr. CTA)

Work Location: Middlesex County, MA

Summary:

The Contract Sr. Clinical Trial Associate (Sr. CTA) will coordinate, administer, and support the logistical aspects of clinical trials, ensuring compliance with regulatory requirements and maintaining audit readiness. This role involves collaboration with internal teams, vendors, and CROs, and requires strong organizational and communication skills to support clinical study planning and execution.

Responsibilities:

• Coordinate and track distribution and retrieval of essential clinical documents, including protocols, amendments, Investigator Brochures, and informed consent forms.
• Maintain and support an inspection-ready Trial Master File (TMF) by performing quality checks and ensuring compliance with ICH-GCP and SOPs.
• Oversee and support clinical studies by interacting with CROs and vendors to meet project timelines and budget requirements.
• Track, review, and finalize key clinical study documents and regulatory submissions, ensuring high quality and accuracy.
• Assist in maintaining continuous audit and inspection readiness for clinical trials.
• Contribute to the development of study-related documents, training materials, and management of clinical study materials and presentations.
• Review meeting minutes, follow up on action items, and support day-to-day operational activities with assigned vendors.
• Foster strong collaborative relationships with external vendors and ensure documentation aligns with GCP and study protocols.

Qualifications:

• Minimum of 4 years of progressive experience in clinical operations within biotech, pharmaceutical, CRO industry, or equivalent clinical research experience.
• At least 2 years of experience supporting multiple clinical trials in biotech or pharmaceutical settings.
• Strong knowledge of ICH-GCP guidelines, regulations, and the drug development process.
• Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
• Proficiency in Microsoft Word, Excel, Outlook, PowerPoint, and MS Project.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced environment with internal and external team members.
• Strong analytical, problem-solving, planning, organization, and time management skills, with the ability to prioritize multiple projects.

Published Category: Clinical Operations & Development