Clinical Trials Associate (CTA)

Location
Bothell, Washington State (US)
Salary
Competitive salary and benefits
Posted
Apr 25, 2018
Closes
Jun 25, 2018
Education
BS
Hours
Full Time

<p>Seattle Genetics is passionate about making a positive impact on the lives of patients with cancer. Employees bring that enthusiasm to everything they do, striving to attain their individual goals while recognizing the power of working collaboratively to realize Seattle Genetics' vision of improving patient outcomes. View this career recruitment video to learn about Seattle Genetics' culture and hear directly from chemists, clinical researchers and sales professionals. As a company working at -- and advancing -- the cutting edge of antibody-based therapies, Seattle Genetics fosters an environment that recognizes the challenges of breaking new ground and creates opportunities for intellectual and professional growth. State-of-the art facility gives our team members the resources to succeed. Located in Bothell's Canyon Park area, Seattle Genetics is close to major highways, dining and shopping. If you are passionate about bringing the best of yourself to everything you do, Seattle Genetics offers challenges, opportunities and rewards for making your best even better. We want to hear from you!</p>

Clinical Trials Associate (CTA)

Summary:

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. 

Responsibilities:

  • 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)

Qualifications:

  • 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.

 

Similar jobs

Similar jobs