Scientific Reviewer

Location: IC: CSR Street: 6701 Rockledge DriveBldg: x Room:3030

City:Bethesda State &Zip: MD 20892

Weekly Hours FT: 3040 hours perweek

Overall Position Summary andObjectives

Providesupport services to satisfy the overall operational objectives ofthe Center for Scientific Review. The primary objective is toprovide services and deliverables through performance of supportservices.

Min EducationPhD

Resume MaxPages 3 Certifications & Licenses Ph.D.in the biological or behavioral biomedical sciences. Field of Study Biology SoftwareMicrosoft office Skills Expertise in HumanSubjects research; expertise in human clinical trials. Statement of Work Details

Other

• Perform an administrative review of incominggrant and cooperative agreement applications hereafter:applications to identify whether the studies proposed in theapplication areare not an NIHdefined clinical trial1
• Identify applicationscontaining NIHdefined clinical trials by applying the NIHdefinition of a clinical trial to the research plans described inthe application 2
• Determinewhether applications have been submitted on an appropriate fundingopportunity announcement FOA or submitted in appropriate FOA butsubmitted asan inappropriate type as a clinical trial when theapplication is not proposing a clinical trial3
• Determine whether the FOAused for submission allows clinical trials or does not allowclinical trials and whether the research plans described in theapplication are compliant with the terms of the FOA under which theapplication is submitted
• Prepare daily reportfor Division of Receipt and Referral DRR staff; list applicationsOnan inappropriate FOA with a short description of theproblem
• Prepare reports to documentnoncompliant applications
• Collaborate with DRRstaff on reviews
• Respond to queries from NIHstaff and affected applicants as needed to explain NIH clinicaltrial policy and how it applies to specific applications
• Use knowledge of policy and sound judgement to provideadvice to withdraw non compliant applications
• Perform other tasks related to administrative review ofhuman subjects clinical trial applications

1 2 3 represents priority rankings where 1 ishighest priority and 3 is lowest priority of those ranked

Deliverables

Workproducts and documents related to performing administrative reviewof incoming grant and cooperative agreement applications; identifyapplications containing NIHdefined clinical trials. AdHoc Workproducts and documents related to determining whether applicationshave been submitted on an appropriate FOA or submitted inappropriate FOA but submitted as an inappropriate type (as aclinical trial when the application is not proposing a clinicaltrial). AdHoc Work products and documents related to determiningwhether the FOA used for submission allows clinical trials or doesnot allow clinical trials and whether the research plans describedin the application are compliant with the terms of the FOA underwhich the application is submitted. AdHoc Work products anddocuments related to preparing daily report; list applications onan inappropriate FOA with a short description of the problem;prepare reports to document noncompliant applications. AdHoc Workproducts and documents related to collaborating with DRR staff onreviews; perform other tasks related to administrative review ofhuman subjects/clinical trial applications. AdHoc

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