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Senior Clinical Trial Assistant

Location: Seattle, Washington
Since 2001 Hansell Tierney has been one of the premier staffing and recruiting companies in Seattle Washington. As a Certified Women’s Business Enterprise (WBE), Hansell Tierney was created to serve and staff Northwest companies by doing things the right way, not just the easiest. We strive to do better by partnering with candidates, treating your experience as one of our own, providing our candidates with interesting local opportunities, and handling every relationship with the highest level of customer service possible. Our business is built on the deep understanding of the job market and the ability to over-deliver on our promises.

We are currently helping our client with a search for a Senior Clinical Trial Assistant.

Duration -  5 month contract
Location -  Seattle, WA
US citizens and those authorized to work in the US are encouraged to apply
Work sponsorship is not available at this time

SUMMARY:
The Senior Clinical Trial Assistant is responsible for providing operational support to multiple cross-functional global Study Teams through all phases and stages (start-up, conduct and close-down) in accordance with appropriate quality standards including ICH/GCP and applicable regulations. This person plays a key role in supporting the conduct of clinical trials and to the Juno Clinical Operations department and assigned study teams. Required skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing conditions, and team building. The Senior CTA possesses strong communication skills, is highly competent in the Microsoft Office Suite (including MS Word, Excel, PowerPoint and SharePoint), and has experience working in a fast-paced environment within the biotech/pharmaceutical industry.

ESSENTIAL DUTIES:
  • Identifying and resolving gaps in processes or procedures.
  • Leading broad and/or cross-functional projects for the Clinical Operations team and managing project timelines and deliverables. This may include delegation of responsibilities to junior staff.
  • Providing guidance and direction to other CTAs, developing associated training materials and training teams on how to use processes and tools.
  • Designing and assembling startup document packets, site reference binders, study worksheets, newsletters and similar materials.
  • Generating communications to field based CRAs on new or revised administrative procedures and ensuring associated processes are followed.
  • Proactively identifying department tracking needs and the appropriate systems (existing or new) for tracking.
  • Entering and auditing investigator, investigative site, and vendor and/or contractor information into the Clinical Trial Management system (CTMS).
  • Communicating with internal and external study team members and vendors.
  • Producing, distributing, and tracking safety mailings (including IND safety report notifications) with internal and external stakeholders.
  • Scheduling and managing meetings on behalf of Clinical Study Managers and other Clinical Operations staff.
  • Preparing meeting agendas and minutes, and archiving agendas and minutes in the clinical trial master file (TMF) as appropriate.
  • Compiling, printing and distributing clinical data for review and reconciliation by cross-functional study team members.
  • Maintaining Clinical Operations and study team calendars.
  • Serving as a super-user for the CTMS and TMF systems and working with Clinical Operations leadership to establish workflows for document processing.
  • Creating and maintaining a master list of study documents and significant communications for assigned study(ies).
  • Receiving, reviewing, categorizing, and filing essential documents into the TMF.
REQUIREMENTS:
  • Bachelor's degree (or equivalent experience) with experience in a clinical research or health care related industry
  • Minimum 4 year of clinical operations experience within a multi-center clinical trial               
  • Experience with clinical trials and the pharmaceutical industry
  • Knowledge of ICH/GCP
  • Highly competent in Microsoft Office Suite (including MS Word, Excel, PowerPoint and SharePoint)
  • Experience working as part of a large team with a proven ability to make an active contribution to the team's performance and team work
  • Strong written and verbal communication skills
  • Highly organized and detail-oriented
  • Problem-solver who prioritizes assignments ensure that tasks are completed on time
  • Strong team player, self-motivated and displays initiative. Moves actions forward without the need for continual supervision
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Hansell Tierney 2955 80th Ave SE Suite 102 Mercer Island WA 98040 Office: 206-232-3080 Email: info@hanselltierney.com