Clinical Research Assistant

Clinical Research Assistant
Duration: 12 months
Location: Bothell, WA
 
DESCRIPTION:
Support critical clinical research activities across multiple businesses and device platforms enabling innovation across sectors.

RESPONSIBILITIES
 • Entry of data into Clinical Trial Management Software (CTMS) 
 • Generation of reports in CTMS 
 • Assist Clinical Research Associates with the following clinical study related activities including but not limited to: 
 • Support Institutional Review Board submissions / document prep and correspondence (initial, amendments, renewals) 
 • Support site / study training 
 • Assist in preparation of site training / study initiation materials 
 • Create and maintain study binders 
 • Contact and coordinate study participant recruitment and enrollment for internal trials, including: 
 • Retain documentation necessary for this process 
 • Initiate, coordinate, and manage activities associated with external patient trials and focus group meetings, including locating participants, securing meeting locations, developing trial procedures, and designing survey materials 
• Conduct quality audits through monitoring internally and externally (remotely or onsite) to ensure compliance with US or international regulations 
 • Maintain traceability and accountability of study devices 
 • Follow procedures to order study equipment 
 • Assist with device labeling, modified product process, set-up and shipments 
 • Manage return and disposition of study equipment 
 • Manage (generate and track) Purchase Orders (PO’s) to facilitate study payments to sites and vendors 
 • Data Entry and Validation 
 • User Assessment Testing (UAT) of Electronic Data Capture (EDC) system 
 • develop Excel spreadsheets for data capture 
 • validate / audit per validation plan 
 • Initiate and track requests for legal agreements 
 • Support the timely and accurate compilation of: all study data, study reports, including SAP file / document entries 
 • Maintain professional relationships with internal associates 
 
REQUIRED SKILLS
• BA or BS in biological sciences or related field, or RN or if an Intern a student in one of these areas 
• work experience in life science or medically related field 
• prior experience providing administrative support in a clinical trial or data management setting 
• awareness and working knowledge of applicable clinical research regulatory requirements i.e., good clinical practice (GCP) and International Conference on Harmonisation (ICH) guidelines preferred 
• knowledge and experience in budgeting, accounting and contracting is preferred 
• self-motivated individual able to manage multiple tasks and priorities in an efficient manner 
• Can work independently without direct supervision as well as in a team environment 
• ability to work according to standard operating procedures 
• computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint 
• strong written and verbal communication skills in English 
• effective time management, planning and organizational skills 
• attention to detail and accuracy in work 
• strong problem-solving skills and proactive attitude
 

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