Clinical Trials Associate (CTA)

Bothell, Washington State (US)
Competitive salary and benefits
Apr 25, 2018
Jun 25, 2018
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Clinical Trials Associate (CTA)


Assist clinical study teams in the execution of clinical trials with dotted line reporting to the study Protocol Lead (PL).  Primary responsibilities may include establishing and maintaining the Clinical Trial Master File (CTMF) and Clinical Trial Management System (CTMS) in an inspection-ready state, and assisting with production and distribution of study materials and site communications. 


  • Assist with the creation and maintenance of documents and plans for assigned clinical studies including but not limited to training materials, study binders, plans, presentations, and reports
  • Establish and maintain the CTMF and CTMS.  Under the supervision of the PL and/or CPM, review the CTMF/S for compliance. Produce reports and status metrics as requested
  • Communicate directly with sites and CRAs to obtain Essential Documents
  • Schedule/set-up/open meetings, telecoms, and Web/Ex. Prepare meeting agendas, minutes, and track action items as assigned
  • Maintain and distribute up-to-date site, vendor and study contact information
  • Ensure timely distribution of clinical trial related materials to sites, study team, CRAs and vendors
  • Under supervision of the PL, may assist with data cleaning activities such as CRF review, listings production and review, and query generation
  • Assist in preparation and follow-up of company-sponsored site quality audits as well as regulatory authority inspections
  • Assist with investigational product distribution and study-wide accountability
  • Assist with review of clinical trial related invoices
  • Assist with reconciliation of planned versus actual visits as related to site payments
  • Adhere to CFR, GCP/ICH, company policies, Clinical Operations and project specific quality documents (e.g. SOPs, work practices, training guides)


  • BS/BA or equivalent preferred and a minimum of 1 year clinical trial experience, preferably within the pharmaceutical or biotechnology industry
  • Basic knowledge and understanding of CFR and GCP/ICH 
  • Proficiency with Microsoft Office Products–Word, Excel, PowerPoint, SharePoint (preferred)
  • Fundamental understanding of filing systems and organizational tools
  • Able to multi-task and prioritize work under limited direction and on own initiative
  • Strong communication and inter-personal skills
  • Able to recommend and implement process improvements
  • Highly responsive and proactive, a team player

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.