We have Job Opportunity for Clinical Specialist at Bothell WA with direct client. Please go through Detailed Job description below.
Duration: 12 months. Contract only
Here is a brief Job description:
In this role, you have the opportunity to
· 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
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
If you have the above qualification and interested to apply please reply with your updated resume, contact no. and expected pay rate and I will contact you to discuss further.