Clinical Informatics Applications Specialist

Overall Position Summary and Objectives

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.

Deliverables:

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

Work Details:

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

Supports clinical staff develop, implement and maintain clinical research data files and materials.

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.

Collects research data and prepares information for inputs and analysis.

Supports the development of forms and questionnaires.

Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.

Monitors subject's progress and reports adverse events.

Supports assembly, development and review of new research projects.

Supports the creation and management of clinical websites and web-based tools.

Organizes and performs clinical research, utilizing internet and other available clinical resources.

Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.

Supports clinical staff develop, implement and maintain clinical research data files and materials.

Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.

1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked

Minimum Education

Bachelor's

Additional Qualifications:

Certifications & Licenses

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.

Field of Study

Community and Public Health

Software

Expertise in Microsoft Office Suite (MS Word, Excel, Outlook, PowerPoint).

Skills

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.

Skill in scientific writing and the ability to distill and provide concise summaries of a broad spectrum of clinical informatics issues.

Strong communications skills, both oral and written.

Excellent analytical, organizational and time management skills.

Keeping abreast of current relevant literature.