Clinical Trial Associate II

Clinical Trial Associate II

Waltham, Massachusetts

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.

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

Salary Range

$86,000 - $105,000 USD

For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grantsbecause your well-being and future matter to us.

Equal Employment Opportunity Information:

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.