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 the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), Office for Policy in Clinical Research Operations (OPCRO), Rockville, MD.
- Work closely with federal staff to develop and implement Clinical Trials Agreements (CTAs), Confidential Disclosure Agreements (CDAs), and other critical agreements with external stakeholders involved in the conduct of clinical research sponsored by the Division of AIDS.
- Develop recommendations for positions and solutions to resolve issues that arise involving established agreements or agreements being processed.
- Maintain adherence to DAIDS-wide policies, standard procedures, and guidance documents on all aspects of agreements necessary for DAIDS clinical research and relevant topics.
- Ensure documents are in accordance with Federal Guidelines on Inherently Governmental Functions and NIH Policy on Relations with the Office of General Counsel.
- Provide support to DAIDS staff, investigators, and collaborators on clinical research agreements including the choice of the type of agreement to be selected and any legal/regulatory issues that arise.
- Collaborate with other components of NIAID and NIH, including the Office of General Counsel and the NIAID Office of Technology Development (OTD) to harmonize CTA templates and provisions across various divisions of NIAID and to address issues that arise in agreement processing.
- Establish methods to evaluate the effectiveness and timeliness of the development of clinical research agreements and to ensure the compliance of agreements with established requirements, standards, and procedures.
- Develop frequently asked questions and other informational and guidance documents derived through DAIDS experience in processing CTAs.
- Assist federal client in developing Memoranda of Understanding (MOU) and Interagency Agreements (IAA) to support Division’s goals.
Experience Required / Requirements
- JD degree or advanced degree in a biological field (MS or PhD).
- Minimum of three (3) years of clinical research regulatory affairs experience.
- Experience negotiating clinical trials agreements is required.
- 100% Medical, Dental & Vision premium coverage for Employees
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Match
- Tuition reimbursement and professional development opportunities
- 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.