What You’ll Do:

The Clinical Trial Associate II will provide support to the Director of Clinical Operations in the conduct of trials and may be responsible for managing startup activities, vendor communication, internal meetings, or other project activities, as assigned. They will perform work within established protocols under general supervision, established processes, and regulations. 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Assists with preparation of all external and internal documentation for assigned trials, to ensure such documentation is completed in accordance with ICH GCP requirements and is consistent with the study protocol, under close supervision
• Supports Clinical Trial Manager(s) in site management activities, which could include review of monitoring visit reports, communication with monitors and sites, review of site essential regulatory documents, and other activities as assigned
• Manages and regularly updates clinical trial tracking tools and systems that provide metrics and tracking of a clinical trial's progress, including participant recruitment, trial supplies, lab samples, and participant disposition
• Maintains and tracks revisions to clinical trial documentation for accuracy, including participant Informed Consent Forms and study plans
• Prepares and/or reviews meeting minutes for cross-functional study team meetings
• Assists the Clinical Trial Manager in ensuring compliance with Clinical Study Protocol(s) and provides timely updates
• Organizes and prepares study files for submission to the Trial Master File within established guidelines
• Responsible for tracking internal study team training, and managing training requirements
• Tracks delivery and receipt of required supplies and materials to study sites and provides regular status updates
• Performs other duties as assigned

Required Qualifications:

• 2-5 years of relevant experience in a pharmaceutical/biotechnology or CRO environment, or academic research
• Has a basic understanding of ICH GCP regulations and clinical protocols
• Exhibits ability to ‘multi-task’ effectively
• Ability to interact well with various team members and provide value added support to projects
• Displays ability to independently solve routine problems following standard policies/procedure
• Proficient computer skills using Microsoft Word, Excel, PowerPoint, etc.
• Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility
• Strong organization and communication skills

Education:

• BS/BA, Life Science degree is a plus