• Creates or assists with developing Operational Specification Documents to define client requirements.• Completes or assists with reviewing IT (LIS) database verifications and assures they are completed before specimen receipt and reporting for specific projects.• Completes or assists in maintaining the task list for Project Initiation on SharePoint.• Completes or assists in uploading finalized documents in SharePoint.• Creates or assists with developing customized test requisitions, laboratory manuals, and specifications for collection kits.• Liaise with colleagues to ensure setup-related tasks required have been performed.• Schedules or assists in scheduling meetings during the study initiation phase.• Mentors and trains new team members.

• Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable in accordance with the requirements of the Clinical Protocol.• Collaborate with colleagues during planning & handover meetings regarding project timelines, and project-related issues focusing on capabilities within Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management.• As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings.• Coordinate and mentor more junior staff; may assist in training new staff

• Completed quality control inspections for all products• Conducted compo• Completed quality control inspections for all products• Conducted component and product testing to assure expectations were met• Managed and maintained product technical document forms and retained a log for all incoming products• Assisted with inventory management of all productsnent and product testing to assure expectations were met• Managed and maintained product technical document forms and retained a log for all incoming products• Assisted with inventory management of all products

• Tested medical devices and biological samples using membrane filtration and pour plate methods to test for aerobic, fungal, anaerobic, and spore former growth• Trained lab technicians on proper plate counting, data collection technique, and all testing techniques• Used proper aseptic technique in preparing and testing samples• Highly skilled in micropipetting and advanced knowledge of microscopes• Performed all levels of bioburden testing• Utilized StarLIMS for recording all findings• Counted microbial plates for bacterial colonies and recorded proper data• Experienced in completing and reviewing laboratory investigations reports