Job Title: Clinical Trial Associate

Work Location: Middlesex County, Massachusetts

Summary:

This contract position supports late-phase clinical trial operations, focusing on Trial Master File (TMF) management, inspection readiness, and collaboration with internal and external stakeholders. The role requires sponsor-side experience and the ability to work onsite two days per week. The contract runs through the end of 2026, with potential for extension.

Responsibilities:

• Support daily operational activities for assigned clinical trials, ensuring objectives and timelines are met in compliance with regulatory guidelines and SOPs.
• Maintain and update clinical trial files, including eTMF and tracking systems, with a focus on inspection readiness and quality control.
• Collaborate with team members to support onsite activities and foster a cooperative work environment.
• Coordinate with Clinical Sample Management for biomarker testing logistics involving third-party and central laboratories.
• Work with CROs and vendors to facilitate timely training and system access for external partners.
• Organize project team and departmental meetings, including preparation and management of related documentation.
• Assist with vendor and clinical site agreements, budget tracking, purchase orders, and invoice reconciliation.
• Build and maintain strong relationships with stakeholders, CROs, vendors, and clinical sites to support trial success.

Qualifications:

• Bachelor’s degree in a science-based discipline preferred.
• At least 2 years of experience in a clinical research environment, with sponsor-side experience required.
• Experience with late-phase clinical trials; exposure to BLA submission is a strong plus.
• Demonstrated expertise in TMF/eTMF management, inspection readiness, and quality control.
• Understanding of drug development processes and ICH GCP guidelines.
• Strong organizational skills, attention to detail, and ability to manage multiple tasks simultaneously.
• Excellent verbal and written communication abilities.
• Ability to commute to Middlesex County, Massachusetts for onsite work two days per week.

Published Category: Clinical Operations & Development