Clinical Trials Associate

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 Trials Associate will provide support to the Clinical Trial Manager(s) 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.

Responsibilities:

• Assists with preparation of all external and internal documentation, for assigned trials, to ensure such documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocol, under close supervision
• Assists Clinical Trial Manager(s) in site management activities which could include review of monitoring report tracking of site visits, communication with monitors and sites, and other activities as assigned
• Develop and regularly update clinical trial tracking tools and systems that provide metrics and tracking of a clinical trial's progress, including participant recruitment, trial supplies, blood samples, and participant disposition
• Maintains and tracks revisions to all documentation for accuracy, including participant Informed Consent Forms
• Assists the Clinical Trial Manager in ensuring compliance with Clinical Study Protocol and provides timely updates
• Organizes and prepares study files related to study tracking and reporting and submits them to the Trial Master File within established guidelines
• May participate in the training of CRO teams, investigators and staff as needed regarding assigned logistics of the clinical trial
• Tracks delivery and receipt of required supplies and materials to study sites and provides regular status updates
• Performs other duties as assigned

Qualifications:

• 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
• High School diploma or equivalent
• Preferred - Associates or Bachelor's degree in life sciences
• 2+ years of relevant experience in a pharmaceutical/biotechnology or CRO environment, or academic research
• 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

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.