Contract Clinical Trial Associate

Contract Clinical Trial Associate

Our Waltham based client is seeking a Contract Clinical Trial Associate to support Clinical Operations in ensuring delegated trial activities are executed to expected quality standards. This role is largely self-directed, with guidance from senior staff and collaboration across functions.

Key Responsibilities

• Study team coordination including agendas and meeting minutes for cross-functional meetings
• Support site start-up activities
• Manage ancillary vendors as assigned
• Participate in and present at Investigator Meetings
• Track Form 1572 submissions and liaise with Regulatory for IND-related documents
• File and QC essential documents in the Trial Master File
• Assist with informed consent templates, study manuals, and other study documents
• Contribute to review of protocols, IBs, and CSRs
• Perform sample management
• Maintain study trackers, tools, and operational documentation
• Additional clinical operations tasks as assigned

Required Qualifications

• Bachelor's or Master's degree with 13 years of relevant experience in pharma, academia, or a CRO
• Working knowledge of ICH Guidelines, GCP, and regulatory expectations
• Ability to manage components of clinical trials with general guidance

Preferred Capabilities

• Ability to learn tools and processes that improve operational efficiency
• Understanding of data flow, technology systems, and vendor metrics
• Strong verbal, written, and presentation skills