Clinical Trial Associate/ Sr CTA

Job Title: Clinical Trial Associate/ Sr CTA

Work Location: Suffolk County, Massachusetts

Summary:

The Clinical Trial Associate/ Sr CTA provides essential support to the clinical team in the management, planning, and execution of clinical research studies throughout the development lifecycle. This role involves evaluating and analyzing clinical data, assisting with vendor oversight, and supporting Clinical Project Managers in various trial activities. The position operates under established protocols and general supervision.

Responsibilities:

• Support site management activities, including monitoring report reviews, site visit tracking, and communication with monitors and sites, or tracking vendor metrics if outsourced.
• Coordinate and participate in investigator meetings, training sessions, and facilitate vendor performance tracking.
• Contribute to the review and preparation of packages for initial EC/IRB submissions.
• Oversee site payment processing by tracking confidentiality agreements, contracts, and payments for sites and vendors.
• Participate in training vendor teams, investigators, and staff on clinical trial logistics as needed.
• Maintain study documentation in compliance with ICH guidelines and SOPs.
• Assist with audit and inspection preparations for the clinical team.
• Compile monthly statistics on participant status and clinical research activities, and communicate with vendors to track study metrics.

Qualifications:

• Bachelor’s Degree.
• 1-3 years of experience in clinical research.
• Basic understanding of the drug development process, including clinical study phases and post-marketing studies.
• Knowledge of interactions among sponsors, investigators, ethics committees, and regulatory agencies.
• Familiarity with medical terminology and medical record components, with the ability to apply this knowledge in document review and creation.
• Ability to build productive working relationships both internally and externally.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook).
• Strong oral and written communication skills.

Published Category: Clinical Operations & Development