Clinical Trial Associate, Business Operations

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 Business Operations Clinical Trials Associate supports the Business Operations and Clinical Outsourcing function which supports the conduct of trial.  The CTA may be responsible for supporting clinical technology tools, maintaining vendor contracts, supporting vendor oversight, tracking 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:

• Develop and maintain tracking system for clinical trials contracts and change orders in collaboration with Legal Contracts Administrator
• Develops and maintains tracker of all clinical operations vendors used on clinical trials
• Support clinical trial insurance process, coordinating with study team (including Finance) and CRO team members to collect appropriate documentation.  Tracks key information for each policy.
• Coordinates work of clincialtrials.gov registry vendor and act as a liaison between study teams and vendor
• Responsible for downloading data and aggregating regular performance reports of CRO operational metrics across the portfolio.
• Develops and maintains trackers of clinical trial information as required
• Assists CRO oversight activities which could include review of monitoring trip reports, tracking of site visits timeliness, scheduling oversight visits and other activities as assigned
• Supports the training of CRO teams, investigators and staff as needed regarding clinical trial technology tools
• Performs other duties as assigned

Required 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
• 2+ years of relevant experience in a pharmaceutical/biotechnology or CRO environment, or academic research
• Strong computer skills using Microsoft Word, Excel, PowerPoint, etc.
• Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility

Preferred Qualifications:

• Experience with Power BI and Microsoft SharePoint

Education:

• High School diploma or equivalent
• Associates or Bachelor's degree in life sciences preferred

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.

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