Clinical Trial Associate

Position Overview

Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, Navenibart, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in pre-clinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.

The Clinical Trial Associate (CTA) actively participates in a variety of activities to support and facilitate the efficient conduct of patient trials in our clinical research programs. Reporting to the Senior Clinical Trial Manager, you will be responsible for supporting the critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols.

Responsibilities

• Work with Senior Clinical Trial Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
• Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTM.
• Serving as the sponsor liaison to clinical sites during the activation process, as the study progresses, and during study close-out.
• Manage deliverables, navigate changing priorities and communicate any changes.
• Coordinate and attend study team meetings; take, distribute, and file meeting minutes.
• Maintain and generate applicable study trackers (for example: patient enrollment and IRB approvals).
• Overall management of the Trial Master Files (internal and CROs) including managing set-up, maintenance, and periodic QC.
• Manage the Clinical Operations internal document filings and tracking.
• Participation in evaluation of clinical trial site locations.
• Traveling to sites as necessary to assist with site qualification, initiation, and close-out.
• Working with clinical site staff and investigators to obtain study data, ensure protocol compliance, and guarantee patient safety.
• Participating in regional and global conference calls and meetings to review progress of ongoing clinical trials.
• Reviewing incoming clinical data and preparing reports and presentations on the status of clinical studies.
• Helping to draft study manuals and protocol amendments as needed.
• Organizing and distributing study supplies and study-related documentation required for conduct of clinical trials.
• Perform departmental tasks.
• Professionally interact and communicate with internal departments (Legal, Regulatory, Safety, etc.), CROs, and external vendors.
• Perform developmental tasks with oversight of Clinical Trial Manager.
  
  

Qualifications

• Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field.
• 1 or more years of clinical research experience in industry settings.
• Knowledge of clinical trial methodology as well as the drug research and development process.
• Knowledge of GCP/ICH Guidelines for clinical studies.
• Ability to work independently and take initiative in a fast-paced work environment.
• Excellent verbal and written communication skills.
• Competent computer skills including Microsoft Office.
• Familiarity with clinical systems
  
  

Astria’s Commitment

At Astria, we are committed to building a diverse team where every Astrian endorses the idea that people bring their authentic self to work. We embrace a patient-first, people-always culture which strives to ensure all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote diversity, equity, and inclusion throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contributions.  

People are our greatest asset, and only with a diverse team can Astria shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families, and communities.