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 Research Coordinator to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Office of Regulatory Science (ORS), Bethesda, MD.
- Archive records and entry of regulatory activities within the various data management systems for VRC Investigational New Drug (IND) applications and other regulatory submissions
- Work closely with the members in VRC/ORS to coordinate and ensure the successful completion of the regulatory activities within the agreed timelines and in compliance with applicable regulations
- Provide regulatory operations support to the VRC regulatory office through document control management and quality assurance
- Work on special projects in the VRC/ORS to assist ORS staff in meeting VRC, IRB ad FDA timelines
- Interact with other components of the VRC involved in product development (Clinical Trials Program, Translational Research Program and Vaccine Production Program) to obtain, assist writing and review of non-clinical and CMC data
- Assist ORS personnel with developing templates and letters for regulatory submissions to the FDA and sites
- Verify the integrity of sponsor files, ensuring the availability of clinical and non-clinical materials, review the required documentation in the document control system according to the current practices and applicable guidelines, and check for consistency with the contents of sponsor files
- Assist with developing and managing VRC/ORS tracking databases to support regulatory filings and ensure Sponsor’s commitments are met
- Develop and implement SOPs and work instructions for VRC/ORS processes
- Complete quality review of internal documents and eCTD submissions as needed
Experience Required / Requirements
- Bachelor’s degree in biology, biochemistry or other life science
- Minimum of one (1) to two (2) years of experience in Regulatory Affairs
- Background in document management, and/or archiving systems is desirable
- Working knowledge of and aptitude for activities related to quality assurance
- Strong verbal and written communication skills and ability to work in a group setting and collaborate with other functional areas
- Advanced knowledge of Microsoft Word, Adobe Acrobat and electronic document management systems
- Knowledge of Title 21 Code of Federal Regulations (CFR) (GCPs, GLPs GMPs) to ensure FDA regulatory compliance
- 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.