Position Objective: Provide services as a Scientific Reviewer in support of the overall functions of the Center for Scientific Review (CSR) within the National Institutes of Health (NIH). Provide support services to satisfy the overall operational objectives of the Center for Scientific Review. The primary objective is to provide services and deliverables through performance of support services.

Duties and Responsibilities:

• Perform an administrative review of incoming grant and cooperative agreement applications hereafter: applications to identify whether the studies proposed in the application are not an NIH-defined clinical trial. 1
• Identify applications containing NIH-defined clinical trials by applying the NIH definition of a clinical trial to the research plans described in the application. 2
• Determine whether applications have been submitted on an appropriate funding opportunity announcement FOA or submitted in appropriate FOA but submitted as an inappropriate type as a clinical trial when the application is not proposing a clinical trial. 3
• Determine whether the FOA used for submission allows clinical trials or does not allow clinical trials, and whether the research plans described in the application are compliant with the terms of the FOA under which the application is submitted.
• Prepare daily report for Division of Receipt and Referral DRR staff; list applications on an inappropriate FOA with a short description of the problem.
• Prepare reports to document noncompliant applications.
• Collaborate with DRR staff on reviews.
• Respond to queries from NIH staff and affected applicants, as needed, to explain NIH clinical trial policy and how it applies to specific applications.
• Use knowledge of policy and sound judgement to provide advice to withdraw noncompliant applications.
• Perform other tasks related to administrative review of human subjects clinical trial applications.
• Work products and documents related to performing administrative review of incoming grant and cooperative agreement applications; identify applications containing NIH- defined clinical trials. - Ad-Hoc
• Work products and documents related to determining whether applications have been submitted on an appropriate FOA or submitted in appropriate FOA but submitted as an inappropriate type (as a clinical trial when the application is not proposing a clinical trial). - Ad-Hoc
• Work products and documents related to determining whether the FOA used for submission allows clinical trials or does not allow clinical trials, and whether the research plans described in the application are compliant with the terms of the FOA under which the application is submitted. - Ad-Hoc
• Work products and documents related to preparing daily report; list applications on an inappropriate FOA with a short description of the problem; prepare reports to document noncompliant applications. - Ad-Hoc
• Work products and documents related to collaborating with DRR staff on reviews; perform other tasks related to administrative review of human subjects/clinical trial applications. - Ad-Hoc

Basic Qualifications:

• Ph.D. in the biological or behavioral biomedical sciences, biology, or a related disciple.
• Skilled in Microsoft Office.
• Expertise in Human Subjects research and human clinical trials.

Minimum Qualifications:

• Ability to multi-task and pay close attention to detail.
• Excellent analytical, organizational and time management skills.
• Strong communication skills, both oral and written.

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.