Clinical Advisor IV-17227
Huntington Ingalls Industries - Technical Solutions Division, Integrated Mission Solutions Group (Camber Corporation) provides mission-critical engineering and technical service to Information Technology, Federal Civilian, and National Security, Aerospace & Defense and International government and commercial customers at over 100 locations worldwide.
HII-TSD, Integrated Mission Solutions Group (Camber Corporation) is currently seeking aÂ Clinical AdvisorÂ IV to work on Ft.
The following statements of duties and responsibilities are intended to describe the general nature and level of work being performed by individuals assigned to this position.
These statements are not intended to be an exhaustive list of all duties and responsibilities required of all personnel within this position.
Actual duties and responsibilities may vary depending upon assignments and other factors.
Duties and Responsibilities:
* TheÂ contractorÂ shallÂ serveÂ asÂ theÂ clinicalÂ representativeÂ onÂ projectÂ teamsÂ andÂ supportÂ riskÂ planningÂ efforts.Â
* TheÂ contractorÂ shallÂ collaborateÂ withÂ projectÂ teamÂ members,Â leadingÂ theÂ writingÂ ofÂ clinicalÂ developmentÂ plans.Â Â ï‚·
* TheÂ contractorÂ shallÂ developÂ draftsÂ andÂ assistÂ theÂ projectÂ teamÂ toÂ coordinateÂ responsibilities,Â overseeÂ qualityÂ management,Â andÂ encourageÂ timelinessÂ ofÂ completionÂ ofÂ clinicalÂ studyÂ reports,Â INDÂ applications,Â investigatorÂ brochures,Â CTAs,Â ISEs,Â ISSs,Â andÂ otherÂ regulatoryÂ submissionsÂ andÂ clinicalÂ expertÂ reports.Â ï‚·
* TheÂ contractorÂ shallÂ collaborateÂ withÂ bothÂ internalÂ andÂ externalÂ partners,Â contributingÂ toÂ dataÂ analysesÂ inÂ orderÂ toÂ createÂ andÂ submitÂ clinicalÂ studyÂ resultsÂ toÂ publicationsÂ orÂ theÂ FDAÂ andÂ participatingÂ inÂ theÂ evaluationÂ ofÂ safetyÂ resultsÂ inÂ clinicalÂ studiesÂ inÂ orderÂ toÂ assistÂ inÂ formulatingÂ theÂ emergingÂ safetyÂ andÂ risk/benefitÂ profileÂ ofÂ productsÂ inÂ developmentÂ forÂ clinicalÂ trialsÂ andÂ regulatoryÂ documentsÂ (e.g.,Â IND,Â investigatorÂ brochure,Â informedÂ consent,Â etc.).Â Â ï‚·
* TheÂ contractorÂ shallÂ assistÂ theÂ regulatoryÂ teamÂ inÂ developingÂ aÂ robustÂ productÂ developmentÂ planÂ toÂ supportÂ FDAÂ approvalÂ underÂ theÂ AnimalÂ RuleÂ andÂ establishingÂ aÂ linkÂ betweenÂ clinicalÂ andÂ nonclinicalÂ efficacy.Â
* TheÂ contractorÂ shallÂ reviewÂ draftÂ clinicalÂ protocolsÂ andÂ provideÂ feedback.Â Â ï‚·
* TheÂ contractorÂ shallÂ reviewÂ andÂ searchÂ medicalÂ literatureÂ andÂ databasesÂ inÂ orderÂ toÂ identifyÂ clinicalÂ andÂ technicalÂ informationÂ andÂ toÂ provideÂ referencesÂ toÂ supportÂ clinicalÂ plans.Â ï‚·
* TheÂ contractorÂ shallÂ authorÂ andÂ editÂ technicalÂ reportsÂ (e.g.,Â overallÂ projectÂ conceptsÂ andÂ descriptions,Â testÂ plansÂ andÂ technicalÂ reports,Â etc.).Â Â ï‚·
* TheÂ contractorÂ shallÂ workÂ closelyÂ withÂ theÂ nonâ€clinicalÂ teamÂ toÂ bridgeÂ nonâ€clinicalÂ outcomesÂ t...
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