Title: Clinical Trial Support
Location: Bothell, WA
Duration: 12 Months (Extendable)
Description:
Support critical clinical research activities across multiple businesses and device platforms enabling innovation across sectors.
You are responsible for
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
You are a part of
This position supports global clinical and scientific affairs for Philips which is integral to the assurance of Good Clinical Practice compliance and support of business needs and new product development. Our organization works closely with regulatory, quality, marketing and research and development, among other departments.
To succeed in this role, you should have the following skills and experience
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
Looking forward,
Sachin Patil
APN Software Services, Inc