Clin Trials Mtrl Technician QC
Job Summary
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
Qualifications
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.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.
Required Experience:
IC
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more