Manage outsourcing of clinical analysesCreate statements of work and detailed procedure manualsOversight of contract laboratoriesAssist in drafting of master service agreementsLead meetings, compose detailed minutes, and present progress to a variety of audiencesLiaison between clinical teams and outside vendorsAuthor SOPs, laboratory procedures, and biomarker analysis sections of clinical study reportsAssist in build-out of GCP translational research laboratory and biological sample repository and planning for laboratory move Develop SOPs and site-specific proceduresPlan and establish a new clinical sample repository, including detailed move planning for samples and a new environmental monitoring systemCapital equipment acquisitionAssist in establishing a new GCP/GLP translational science laboratory Organize efforts to identify and implement an electronic sample tracking database for new facilitySupport various aspects of biological sample acquisition and analyses for biomarker analysis in clinical studies including:Contribute to biomarker sections of clinical protocolsDevelop site manuals for collection of biological samples with clinical teamsInteractions with clinical sitesSupervise laboratory operationsSupplies and general operationsOversight of biological sample repository housing over 20,000 clinical study samplesSupervise contract employeesContribute technical and scientific expertise to ongoing programs

Develop, validate and implement exploratory biomarker assays for clinical trialsDraft biomarker assay validation and biomarker study reportsReview of biomarker sections of clinical trial protocols biological sample procedures manuals, and Case Report FormsPart of a team that tested, validated and implemented an electronic laboratory notebook

Develop exploratory biomarker assays for clinical trials and preclinical studiesProvide kits for clinical sitesTrain interns and contract employees

ResponsibilitiesAnalyze samples in the laboratory using techniques such as Western Blot and ELISAValidate clinical specimen tracking and storage databaseTrack, store, and reconcile GCP clinical samplesReview and edit SOPs Assist with necropsies and preclinical specimen preparation