Clin Trials Mtrl Technician QC

Requirements

• High School Diploma or equivalent Req
• 1 year relevant experience . Equivalent combination of education, training and experience.
• Attention to detail.
• Good reading ability.
• Basic computer skills.
• Excellent organizational skills.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.

Benefits

Additional Information

Job Overview Assist with coordination and prioritization of department workload liaising with Project Management and Investigator Services groups (comes out). Ensure accuracy of shipments of laboratory test kits and ancillary supplies. Provide leadership to team in absence of supervisor. Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice. Essential Functions - Assemble visit-specific kits from QLIMS kit building orders - Monitor work orders in laboratory information system (QLIMS) - Print in order of priority to in order meet clients' deadlines - Generate requisitions and associated labels and procedural instructions - Ensure accurate association of all printed material and distribution in priority order to the warehouse for pre-kitting and verification of all materials returned from the warehouse for use in the kits built - Reprint requisitions labels and content instruction sheets from QLIMS - Liaise with Project Management and Investigator Service groups to establish shipping and logistics priorities - Ensure that all work orders are placed in order of priority in the work rack and that CTM staff receive work in the order of priority - Ensure all validation kit orders are prioritized and run swiftly through the clinical trials materials (CTM) checking system - Coordinate with relevant supplier/contractor any repairs to any broken equipment - QC and verify visit-specific kits against Contents Sheet produced from QLIMS, ancillary material specified on the Worksheet, shipping documentation, investigator manuals and flow charts - Record errors in error log and highlight to the appropriate CTM leader for remedial action - Accession out Clinical Trial Material in QLIMS - Train all new staff to a high standard of kit building - Collating and filing all work orders on preparation for archiving - Label final packages as required by courier - Store any pending shipments in the warehouse - Provide leadership to team in absence of Team Leader

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