Axle Informatics
Description
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Overview
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Advisor to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Africa and the Domestic Partners Branch, Office of Clinical Site Oversite, DAIDS.
Responsibilities
- Implement and coordinate a range of individual clinical site-management activities.
- Advise PIs on clinical site start-up and relevant operational and regulatory issues including resource allocation, and administrative issues.
- Provide oversight for planning, organizing, and conducting site visits or reverse site visits as appropriate to clinical trials units/clinical research sites to effectively fulfill site management responsibilities.
- Assess the level of clinical trials research competency of clinical research site staff and the extent of research knowledge and technology available to achieve the desired quantity and quality of research to be conducted at the clinical trials units.
- Evaluate clinical trials units/clinical research sites’ organizational structures and modes of operations in relationship to the achievement of the Division’s goals and objectives in the areas of administration, clinical site management, and recruitment of patients.
- Provide oversight and technical direction for evaluation of site performance.
- Identify problems or issues that transcend individual units or trends that indicate the need for procedural clarification or policy development and recommends follow-up actions or policy directives to OCSO Director or Branch Chief.
- Conduct trainings at sites and Network meetings on relevant policies/regulations.
- Attend local or victual Network meetings, conference calls, ad hoc meetings and working groups.
- Support federal Program Officers by: 1) tracking and summarizing grantee compliance with training requirements, grantee progress in meeting the grant aims by reviewing progress reports, and adherence to applicable regulations; and 2) reviewing and providing input on training materials, policies and procedures.
- Participate in the creation and review of site development and site closure-related documents and checklists.
- Interface with networks, investigators, Operations Centers, to share information and collaborate on research and site-related issues.
- Prepare oral and written presentations for internal and external programmatic and scientific meetings virtually or locally.
Experience Required / Requirements
- Minimum of a BS degree in a science or health related discipline is required.
- Five or more years of progressive experience in managing clinical trials/clinical research sites and/or monitoring of clinical trials is required.
