Clinical Trial Associate

Clinical · Seattle, Washington
Department Clinical
Employment Type Full-Time
Minimum Experience Experienced

 

Company:

 

Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for patients with kidney diseases.  We apply our proprietary research platform to discover and develop therapeutics with novel mechanisms of action against key kidney disease pathways. Our development focus is on rare, serious disorders with clear unmet medical needs and defined and rapid clinical development opportunities.  Our lead program, atrasentan, is a late-stage clinical program for the treatment of primary glomerular diseases, which is planned to move into a phase 3 registrational trial for IgA nephropathy and a phase 2 basket trial for glomerular diseases, both in early 2021. We are also evaluating BION-1301, an anti-APRIL monoclonal antibody, in a phase 1b trial for IgA nephropathy, and are advancing CHK-336 towards a planned IND in 2021 for an ultra-orphan kidney disease.  In addition, our pipeline has several other preclinical programs at the validation and lead optimization stages, and we are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline. 

 

Chinook launched in 2019 with a $65 million Series A financing from leading healthcare investors Versant Venture, Apple Tree Partners and Samsara Biocapital.  In October 2020, we merged with Aduro Biotech, Inc. and completed a $115 million financing with leading healthcare investors, including EcoR1, Orbimed and others.  Chinook now has over $275 million in operating capital and trades on Nasdaq under the ticker “KDNY”.  The company has locations in Vancouver, BC, Seattle, WA and Berkeley, CA.

 

Position:

 

As a vital member of Chinook's Clinical Operations team, the Clinical Trial Associate will assist Clinical Operations, Clinical Trial Management, and Clinical Business teams in the execution of clinical trials. The CTA role will provide day-to-day operational support. Reporting to the Director, Clinical Operations, this is a Seattle and primarily office-based position.

 

 Responsibilities include:

 

  • Support development and maintenance of clinical study tracking tools and files
  • Monitor and track the status of study-related activities and deliverables to help ensure timely completion
  • Provide regular status updates to study teams
  • Help maintain study dashboards
  • Assist with preparation and distribution of written materials, e.g., site training materials, study manuals and plans, presentations, etc.
  • Contribute to trial master file inspection-readiness activities, including periodic review
  • Coordinate, schedule and support various meetings, including agendas, minutes, and updates to decision and action logs as needed
  • Support patient recruitment and retention
  • Assist with clinical data review
  • Assist with Essential Regulatory Document review
  • Perform quality checks
  • Support clinical site management activities
  • Assist with vendor management activities
  • Support implementation, maintenance and administration of clinical systems such as Clinical Trial Management Systems
  • Bridge work between Clinical Operations and Finance to support timely execution of contracts and payments
  • Track and monitor the status of outstanding contracts, budgets, and invoices
  • Assist in the management of study budgets, reconciliation of invoices, liaise with Finance and Contracts teams
  • Perform other administrative duties as assigned
  • Ensure activities are conducted in compliance with applicable regulations
  • Actively learn and increase understanding and awareness related to drug development, clinical trials, related regulations, study indications, scientific understanding, and trial related technology solutions
  • Contribute to the development and maintenance of a positive team-focused company culture

 

Education, Experience, and Skills:

 

  • Bachelor's degree or equivalent, preferably in a health, science, finance, or business-related field
  • At least 2 years prior work experience, preferably in a biotech, pharmaceutical, health, science, finance, or business-related field
  • Prior CTA, Clinical Research Coordinator, Clinical Data Coordinator experience strongly preferred
  • Basic knowledge and understanding of research regulatory guidelines and policies, i.e., GCP/ICH, the Code of Federal Regulation
  • Excellent written/verbal communication skills
  • Proficiency with MS Word, Excel, Outlook, PowerPoint, SharePoint, OneNote

 

 Chinook is an Equal Opportunity Employer and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported.  We respect and value different experiences and viewpoints.  We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

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  • Location
    Seattle, Washington
  • Department
    Clinical
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced