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).
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Advisor to join our vibrant team at Rockville, MD.
- 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, personnel management, and administrative issues.
- Provide leadership for planning, organizing, and conducting site visits or reverse site visits to clinical trials units to effectively fulfill site management responsibilities.
- Assess the level of clinical trials research competency of clinical research sites and the extent of research knowledge and technology available to achieve the desired quantity and quality of the clinical trials units.
- Direct and conduct formal evaluations of the clinical trials units’ 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 using data compiled by the network data management centers.
- Identify problems or issues that transcend individual units or trends that indicate the need for procedural clarification or policy development and recommend follow-up actions or policy directives to OCSO Director or Branch Chief.
- Conduct trainings at sites and Network meetings on relevant policies/regulations.
- Attend 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 training manuals, policies and procedures.
- Participate in the creation and review of study or 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.
Experience Required / Requirements
- RN, Bachelor’s, or Master’s degree.
- Minimum of 3 years of experience in clinical research with an emphasis on regulatory experience.
- Paid Time Off (PTO)
- 10 Paid Federal holidays
- Generous health coverage provided with no monthly premium to the employee
- Generous vision and dental coverage provided with no monthly premium to the employee
- Short and Long-Term Disability coverage (paid by company)
- Basic Life and AD&D coverage (paid by company; option to purchase additional coverage)
- 401(K) with significant company match & no vesting period
- Competitive salaries with performance bonus opportunities
- Discount plan for pet care, legal services, & identify theft protection
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.