Provide services as a Clinical Informatics Applications Specialist in support of the overall functions of the National Institute of Mental Health (NIMH) within the National Institutes of Health (NIH). Under this task order, the contractor will independently provide support services to satisfy the overall operational objectives of the National Institute of Mental Health (NIMH). The primary objective is to provide services and deliverables through performance of support services.

Duties and Responsibilities:

• Participates in the development and administration of informatics and database applications that support clinical research programs and operations. 1
• Participates in the development and revision of institute standard operating procedures (SOPs) related to inclusion, monitoring and reporting, and providing educational training to institute staff on this subject matter area. 2
• Utilizes communication and customer service skills to support users and to problem-solve technology. Conducts quality assurance/quality control activities on data and reviews and resolves data queries as needed. 3
• Functions as a technical resource for the NIH Human Subject System (HSS) module of eRA Federal grants management systems and ClinicalTrials.gov, and stays abreast about system updates in HSS.
• Develops presentations and guidance documents and provides training and education related to supported technology platforms.
• Contributes to the development and preparation of the triannual inclusion report.
• Work products and documents related to quality assurance/quality control (QA/QC) activities on data from CTOS, RMR and HSS. - Ad-Hoc Work products and documents related to performing NIMH data management. - Ad-Hoc
• Work products and documents related to providing ongoing technical advice and education to facilitate the monitoring of progress in clinical trials. - Ad-Hoc
• Work products and documents related to interpreting and providing advice and education on clinical research informatics. - Ad-Hoc
• Work products and guidance documents providing training and education related to supported technology platforms, including RMR, HSS, CTOS, and as well as OCR forms in BPLogix to NIMH staff and external users. - Ad-Hoc
• Work products and documents related to NIMH reports and presentations on enrollment and retention, inclusion, and clinical trial management and oversight, and is the institute lead on the preparation of the triannual inclusion report and presentation to Council. - Ad-Hoc

Basic Qualifications:

• Bachelor's or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position.
• Expertise in Microsoft Office Suite (MS Word, Excel, Outlook, PowerPoint).
• At least one (1) year of qualifying experience developing and administering informatics and database applications to support clinical research programs and operations.
• Knowledge of regulations, policies, and procedures pertaining to the development of clinical informatics applications.
• Skilled in scientific writing.

Minimum Qualifications:

• Ability to distill and provide concise summaries of a broad spectrum of clinical informatics issues.
• Ability to keep abreast of current relevant literature.
• 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.