Clinical Trial Associate

Clinical Trial Associate

Location: Anywhere in the U.S. (Remote Position) – about 10-20% of travel once pandemic restrictions are resolved.

Xentria is a patient-centric biotech company focused on novel biologics and biosimilars. Our first program is XT MAB 16, a monoclonal antibody for sarcoidosis. XT MAB 16 has received Orphan Drug Designation and is currently in a Phase 1 study. 

Xentria is seeking an experienced Clinical Trial Associate to support the Clinical Operations team in study execution and may act as the central contact for project communication and documentation. Reporting to the VP, Research & Development, you will be responsible for supporting the critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols and under the general supervision of the Clinical Project Manager. In this role you will collaborate with Clinical Operations team members, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following (other duties may be assigned).

• Coordinates and attends study team meetings; takes, distributes, and files meeting minutes. 
• Manages deliverables, navigates changing priorities and communicates any changes. 
• Overall management of the Trial Master Files (internal and CROs) including managing set-up, maintenance, and periodic QC. 
• Manages the Clinical Operations internal document filings and tracking. 
• Coordinates tracking of clinical supply shipments, reviews and/or approves study documentation including essential document packets, study plans, informed consent forms, etc.
• Professionally interacts and communicates with internal departments (Legal, Regulatory, Quality, etc.), CROs, and external vendors. 
• Maintains knowledge and acts as team super-user or subject matter expert for related systems and processes; provides presentations, training, and support to Clinical Operations team as needed; provides updates to applicable Clinical Operations resources as needed. 
• Trains other Clinical Operations staff and act as lead for work performed by Clinical Operations staff. 
• Requires strong attention to detail in composing and/or proofreading and/or approving study materials, establishing priorities, scheduling, and meeting deadlines. 
• Up to 25% domestic and/or international travel expected with routine travel to Chicago office.

Supervisory Responsibilities

No direct reports associated at this time.

Competencies

• Teamwork
• Professionalism
• Judgement
• Ethics
• Interpersonal
• Project Management

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Coordinates and attends study team meetings; takes, distributes, and files meeting minutes. 
• Manages deliverables, navigates changing priorities and communicates any changes. 
• Overall management of the Trial Master Files (internal and CROs) including managing set-up, maintenance, and periodic QC. 
• Manages the Clinical Operations internal document filings and tracking. 
• Coordinates tracking of clinical supply shipments, reviews and/or approves study documentation including essential document packets, study plans, informed consent forms, etc.
• Professionally interacts and communicates with internal departments (Legal, Regulatory, Quality, etc.), CROs, and external vendors. 
• Maintains knowledge and acts as team super-user or subject matter expert for related systems and processes; provides presentations, training, and support to Clinical Operations team as needed; provides updates to applicable Clinical Operations resources as needed. 
• Trains other Clinical Operations staff and act as lead for work performed by Clinical Operations staff. 
• Requires strong attention to detail in composing and/or proofreading and/or approving study materials, establishing priorities, scheduling, and meeting deadlines. 

Education and/or Experience Required

• B.S. and/or M.S. degree in a scientific discipline
• At least two years of experience working on clinical studies in pharmaceutical, biotech, or CRO setting

Computer Skills

Microsoft Word, Excel, PowerPoint and Project

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. 

Work Environment

This is a remote position.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.