Clinical Trial Associate II

Responsibilities

• Required location: Waltham, MA (hub-based, onsite 3-4 days per week)
• 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
• Salary Range
• $86,000 - $105,000 USD
• EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:
• E-Verify:
• Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
• #LI-Hybrid

Benefits

Additional Information

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

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