Axle Informatics is a bioinformatics and information technology company that offers innovative computer services, informatics, and enterprise solutions to research centers and healthcare organizations around the globe. With experts in software engineering, bioinformatics and program management, we focus on developing and applying technology tools and techniques to empower decision-making and accelerate the discovery in translational research. 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 Regulatory Affairs Specialist to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute on Drug Abuse (NIDA) located in Baltimore, MD.
Overall Position Summary and Objectives This position is located at the (NIDA), Intramural Research Program (IRP), Office of the Clinical Director (OCD) that supports and facilitates the NIDA clinical research program through leadership and oversight of clinical research practice and provision of critical infrastructure support such as protocol review and monitoring, training of clinical research personnel, data management, biostatistics for trial design and analysis, auditing and monitoring of intramural trials, outreach to promote patient accrual and data collection and storage.
- Meet with lab members to present updates - Ad-Hoc
- Monitoring reports per Investigator/protocol needs - Ad-Hoc
- Assists researchers and medical staffs prepare clinical trial, pharmaceutical and medical device regulatory documentation.
- Assist primary investigators and clinical supervisors obtain and maintain government approval for drugs, medical devices, nutritional products and related healthcare materials.
- Collaborate with primary investigators or project teams to ensure awareness of and compliance with all manner of government regulation.
- Prepare documentation, manage information, and maintain files and data repositories securely and in accordance with regulatory standards.
- Assist editors draft product and procedure language for regulatory accuracy and completeness.
- Document regulatory compliance actions and track progress against predetermined project plans and schedules.
- Aid with all aspects of the protocol lifecycle including initial Investigational New Drug/Device (IND/IDE) submission,
- Institutional Review Board (IRB) submission of protocols, continuing review applications, protocol amendments, annual reports, protocol inactivation with IRB and other regulatory bodies. 2
- Develop and maintain internal regulatory and compliance library for reference by research and medical staffs.
- Works closely with the NIDA Records Management Office in establishing and maintaining a paperless automated document management and tracking system for NIDA protocols.
- Tracks the review process and maintains detailed, complete, and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews. 5
- Compile and maintain IND/IDE Sponsor regulatory files throughout the lifecycle of sponsorship.
- Serves as subject matter expert on regulatory and compliance issues and assists researchers and medical staff track compliance.
- Adhere to standard operating procedures for quality assurance and monitor quality assurance standards.
- Review documents for content, accuracy, and compliance with applicable regulations prior to submission to regulatory agencies. 3
- Monitor key ethical and legal issues related to protection of research participants, adherence to policies for the appropriate use of biospecimens, and adherence to federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens. 1
- Obtain continuing education about current regulatory issues with the Food and Drug Administration (FDA), Sponsor,
- Office for Human Research Protections, and other regulatory bodies.
- Contributes to development and maintenance of clinic and program policies, standard operating procedures and guidelines.
- Serve as a Quality Assurance/Quality Improvement (QA/QI) monitor for the CD and the Clinical Investigators reviewing data collection to provide regulatory guidance, review, and expertise to ensure documentation conforms to applicable regulations and guidelines. 4
- Serve on NIDA IRP-wide QA/QI committees toward improving patient safety and research integrity e.g., Intramural
- Research Protocol Audit Committee (IRPAC).
- Designs and coordinates internal compliance reviews.
- Consults with clinicians and research teams, IRB personnel, Clinical Investigators, contractors, research sponsors, and regulatory personnel regarding regulatory issues, requirements, protocol adherence and interpretation.
- Provide guidance and leadership for the establishment of regulatory standards and templates for regulatory documents.
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Certifications & Licenses
- Institutional Review Board (IRB) Practice Experience
- Human Research Protection Program (HRPP) Certifications
- Good Clinical Practice (GCP) Certifications
Field of Study
- Multi-Disciplinary or General Science
- Microsoft Office Suite Proficiency
- Data Base Management
- Oral and Written scientific communication
- Excellent Inter-personal skills
- Advanced time management and organization
- 100% Medical Dental & Vision Coverage for Employees
- Educational Benefits for Career Growth
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- Profit Sharing
- 401K Matching
- 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 on 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: firstname.lastname@example.org
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.