Clinical Trial Assistant Alder Biopharmaceuticals

CURRENT OPENINGS
Senior Scientist, Target Biology











Fermentation Development Engineer












Drug Safety Specialist












Head of Bioanalytical









Clinical Trial Assistant

The Clinical Trial Assistant will provide Clinical administrative support, Master File maintenance, for clinical development functions. This position also provides support to clinical development teams by reviewing vendor invoices for accuracy against budget, tracking vendor payments and taking meeting minutes during project team meetings.

Administrative Support:
? Assist with preparing and editing, tracking, and routing clinical development documents if requested, for example clinical protocols, informed consents. Assist with production of regulatory submissions.
? Assists with development and production of study materials, essential documents, presentations, reports, submissions, articles, and other materials. Prepare clinical study conduct binders, track and file routine clinical study documents, either generated internally by Alder or received from CROs, including meeting agendas, minutes, status or patient trackers, patient screening logs and other documents as appropriate. Prepare and track courier packages.
? Review vendor invoices for accuracy against budget
? Liaise with Finance to ensure payments are made and tracked
? Assists with travel when necessary
? Assists in preparation for regulatory audits or partnering discussion.
? Performs other duties as required to interface with Clinical Research Organizations and study vendors to ensure successful trial conduct.
? Other administrative support as required.

Master File Maintenance and Clinical Document Control:
? Archive and organize clinical trial master file documents, including clinical study site documents, email correspondence, training materials, and other study documents. Generate filing indexes and maintains currents lists of correspondence. Participate in the development of Alder?s clinical trial master filing structure; create physical and electronic filing structures; print, prepare, file, archive, and track paper and electronic documents according to the master file structure. Increasing familiarity with documents is expected with increasing ability to take on more independent identification and appropriate handing of master file documents. Appropriate version and document tracking is required.
? Clinical development documents include study conduct documents (e.g. protocols, patient consents, CRFs, site qualification and IMP release documents, conduct plans, study status documents, regulatory and ethics submissions, etc.), financial information, clinical copies of clinical site and vendor contracts, correspondence, study status documents, and other study related documents.
? Provide appropriate administrative support, version control, and document tracking for SOPs, other documents maintained under Clinical Control.

Qualifications:
Minimum of 2 years experience in Clinical Operations or similar department.
Bachelor?s degree in a relevant field is preferred.
We are looking for a self-motivated and highly flexible individual who is able to manage multiple tasks and priorities within a fast-paced office environment. Must be expert at using Microsoft Word, Excel, and Power Point. Ability to multi-task, excellent communication skills and attention to detail are all key for this role.

Location:	11804 North Creek Parkway South Bothell, WA 98011 United States