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