Configuration & QC Spec I

This role is to support the Project Management Team (PM) in configuring and QC'ing new studies in all ICL systems according to the specifications on the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables, and study specific Lab Manuals. This would be an excellent opportunity for candidates with 2 to 3 years of experience in lab clinical research with LIMS experience

Job Description

Work closely with the PM team in interpreting the CLW specs and ensuring that all is clear and accurate enough for proper configuration into all systems, seeking guidance on any parameters that need clarification.

* Provide PM with configuration support by entering selected elements of the study's specifications into ICL systems (e.g. PACS, LIMS, and ICOLIMS)

* Create supporting documents for sites that facilitate proper specimen collection, packaging and shipping, Including visit requisitions, reference range tables, study-specific Lab Manuals, and collection guides

* Support PM In the creation of all configuration-related forms, such as Value Calculation Forms and the LIS Forms

* Assist PM in preparing pdf documents for links to ICOLIMS and Read Only drive posting

* When updates or additions are required for collection, packaging, shipping instructions or contact information to a study-specific Lab Manual or Requisitions, work with CS Leadership to determine whether or not those updates are warranted in the Lab Manual or Requisition Template and make those updates accordingly

* Perform new study configuration quality checks on all databases, internal forms and supporting documents to ensure high quality output and adherence to the CLW specs

* Perform level-appropriate quality checks on database and document updates for all amendments performed by PM

* Verify and post documents for Read Only access once finalized, checking for adherence to version history and version control procedures

* Performs additional relevant responsibilities as requested by management

* Provide technical support and guidance to PM for all study configuration tasks