Clinical Research Associate

Clinical Ops (600) · Seattle, Washington
Department Clinical Ops (600)
Employment Type Full-Time
Minimum Experience Entry-level

Chinook Therapeutics Job Description: 

Clinical Research Associate

 

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 therapies with novel mechanisms of action in key kidney disease pathways. Our development focus is on rare, serious disorders with clear unmet medical needs and well-defined clinical development opportunities. Our lead program, atrasentan, is a potent and selective, small molecule inhibitor of the endothelin A receptor that is planned to move into a phase 3 registrational trial for IgA nephropathy and a phase 2 basket trial for glomerular diseases, in 2021. We are advancing BION-1301, an anti-APRIL monoclonal antibody, in an ongoing phase 1b trial for IgA nephropathy, and CHK-336, an oral small molecule LDHA inhibitor for primary hyperoxaluria, towards trial initiation in 2021. Our pipeline also includes several additional preclinical programs at the validation and lead optimization stages, and we continue to actively evaluate business development opportunities around early and late-stage clinical assets in kidney disease. 

 

Chinook completed the third quarter of 2020 with over $290 million in operating capital and trades on Nasdaq under the ticker symbol, “KDNY.”  The company has locations in Vancouver, BC, Seattle, WA and Berkeley, CA.

 

Position:

 

As an important member of Chinook’s Clinical Operations team, the Clinical Research Associate (CRA) role is primarily responsible for supporting early to late stage study and site management activities.

Reporting to the Associate Director, Clinical Trial Management or above, this is a Seattle and primarily office-base position.

 

 

 Responsibilities include:

  • Partner with the Clinical Trial Manager (CTM) and other study team members to support key study activities
  • Ensure conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials
  • Help institute and maintain study tracking tools, including the Clinical Trial Management System (CTMS)
  • Review essential regulatory documents according to SOP and follow up on any issues to closure
  • Help establish, maintain, and review the Trial Master File (TMF)
  • Review site modified Informed Consent Forms and ensure appropriately routed and approved
  • Track and report out on study and site status
  • Support and conduct various site monitoring and vendor oversight activities
  • Perform data cleaning activities as assigned
    • Data listing and patient profile review
    • Issue and follow up on data queries
  • Contribute to management and accountability of Investigational Product and other trial supplies
  • Support management and tracking of research specimen samples
  • Support site, CRO, and internal requests for access to vendor systems
  • Participate in and support study team meetings and related activities
  • Assist with preparation and follow up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections
  • May mentor and help train junior team members including Clinical Trial Assistants
  • Contribute to the development and maintenance of a positive team-focused company culture


Education, Experience, and Skills:

  • 3 years of relevant clinical trial management experience
  • BA/BS or equivalent
  • Knowledge and awareness of CFR, GCP/ICH, and HIPAA requirements
  • Proficiency in Microsoft Office products
  • Highly organized
  • Approachable and responsive
  • Quickly learns new skills and acquires knowledge
  • Comfortably shifts gears
  • Maintains two-way dialog with others on work and results
  • Is a clear communicator
  • Energized by challenges

 


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 Ops (600)
  • Employment Type
    Full-Time
  • Minimum Experience
    Entry-level