Clinical Specialist

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. 

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