Cascadian Therapeutics is a clinical-stage biopharmaceutical company specializing in developing innovative therapeutic product candidates for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of cancer patients. Our most advanced product candidate is tucatinib (ONT-380), an orally active and selective small molecule HER2 inhibitor. We are headquartered in Seattle, Washington. For more information, visit www.cascadianrx.com.
The Clinical Trials Assistant (CTA) plays an integral role in the coordination of clinical trials by providing clinical operations support and in-house assistance to Clinical Research Associates (CRAs), Clinical Trials Management Associates (CTMAs), Clinical Trials Managers (CTMs), and other Clinical Operations staff.
Key Job Responsibilities:
- Serves as primary assistant to internal and external Clinical Operations staff.
- Attends regular study team meetings and takes notes regarding discussions and action items.
- Maintains and generates appropriate study tracking sheets (i.e. tracks patient enrollment and IRB approvals, sends reminders before renewals are due).
- Collects, distributes, tracks and files essential documents; updates Clinical Trial Management System and Clinical Trial Master File.
- Assembles site binders and maintains binder inventories; ships study supplies for U.S. (and Ex-US if required) sites, and maintains a master log of shipments.
- Processes and completes study drug shipments (as requested for U.S. and Ex-U.S. sites); responds to calls/e-mails for drug requests, secures appropriate signatures, routes documentation as appropriate, maintains a log of shipments and tracks receipt at sites.
- Codes Clinical invoices and route for approval.
- Communicates directly with sites, vendors and contractors to obtain updated information, documents, etc.
- Performs other responsibilities as assigned.
Education / Experience / Professional Requirements:
- Associate or Bachelor's degree (or equivalent) and 2 years of experience as a clinical trials assistant/coordinator preferred, including experience having worked on at least 2 clinical studies and supported at least 2 CRAs.
- Proven administrative skills including the ability to demonstrate a well-organized approach to project execution are essential.
- Computer proficiency and familiarity with the suite of Microsoft Office productivity software is required (i.e., MS Word, MS Excel, MS Powerpoint, MS File Maker Pro); experience with Sharepoint is desirable.
- Effective written, verbal and telephonic communication skills are critical.
- Familiarity with medical terminology and/or GCP guidelines strongly preferred.
- Strong attention to detail and proven organization skills are required.
- Requires a highly self-motivated, organized individual with the proven ability to multi-task and manage multiple priorities.
- Must possess strong interpersonal skills and be effective at working in a highly collaborative, team environment.
- Must be able to follow established policies and procedures, and comply with regulatory requirements.
- Willingness to travel as necessary, consistent with the project needs.
Cascadian Therapeutics offers a comprehensive and highly competitive benefits package including medical, dental, vision care, life insurance, short and long term disability, stock options, ESPP, a matching traditional and ROTH 401(k) plan, and fully subsidized transit pass/parking.
If you are interested in working with our team in a collaborative and professional work environment, please Submit Resume ».
We are an Equal Opportunity Employer