Senior Clinical Research Associate

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

Company:

Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1b trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.

 

Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Oakland, CA.


Position:

As an important member of Chinook’s Clinical Trial Management team, the Senior Clinical Research Associate (CRA) role is primarily responsible for supporting early to late-stage study and site management activities. The Senior CRA may act as the clinical trial manager on a small study or lead key activities on a larger global study.  The Senior CRA will also act as backup for the Clinical Trial Manager and may contribute to or lead initiatives in support of department and/or corporate goals.

 

Reporting to a Clinical Trial Manager or above, this is an office (Seattle, Oakland) or remote based position.

 

 Responsibilities include:

  • Assist with the development of study design, protocols, consent forms, CRFs, and other study specific essential documents.
  • Assist in management and oversight of CRO partners and other vendors (may take lead role as development opportunity arises)
  • Partner with the Clinical Trial Manager (CTM) and other study team members to support or lead key study activities, such as trip report review or field CRA training
  • Ensure conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials
  • Lead or support efforts to institute and maintain study tracking tools, including the Clinical Trial Management System (CTMS)
  • Review/approve 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/approve site modified Informed Consent Forms and ensure appropriately routed
  • Track and report out on study and site status
  • Serve as backup to the Clinical Trial Manager
  • Support, and conduct various site monitoring activities
  • Perform/lead data cleaning activities as assigned
  • Support development of data management plans
  • Data listing and patient profile review
  • Issue and follow up on data queries
  • Manage accountability of Investigational Product and other trial supplies
  • Support or lead management and tracking of research specimen samples
  • Contribute to study team meetings, and related activities such as helping establish and maintain study timelines, forecasting tools, dashboards and key performance metrics
  • Assist with or lead key activities in preparation and follow up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections
  • Mentor and  train junior team members including, Clinical Research Associates and  Clinical Trial Associates
  • Contribute to the development and maintenance of a positive team-focused company culture


Education, Experience, and Skills:

  • 5-6 years of relevant clinical trial management experience
  • BA/BS or equivalent
  • Proficient in CFR, GCP/ICH, and HIPAA requirements
  • Proficiency in Microsoft Office products
  • Highly organized and proactive
  • 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.

Thank You

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  • Location
    Seattle, Washington
  • Department
    Clinical Ops (600)
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level