Work with the NIH - NINDS Clinical Trials Unit!

Are you a mastermind for clinical trial protocols? 

Do the clinical research protocols make your hearth sing?  

Axle Informatics and NIH - NINDS are seeking a

Clinical Research Regulatory Specialist 

Join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Neurological Disorders and Stroke (NINDS) located in Bethesda, MD.

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 nationally and abroad.

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 top research organizations and facilities in the country, including multiple institutes at the National Institutes of Health (NIH).

Role: Clinical Research Protocol Navigator

Location: Rockville, MD

Purpose:
Provide clinical research regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned. 

Priorities 

1. Develop and review completed new and amended clinical research protocols and related documentation throughout the lifecycle of the study, with special attention to the accuracy, consistency, and completeness of documents.
2. Develop new and review completed clinical research informed consent and other ethics and regulatory related documentation. 
3. Prepare new and review completed study reports and status updates (amendments, audits, and other administrative documentation)
4. Develop new and review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports. 
5. Maintain all regulatory trial documentation, including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports. 
6. Assist researches with protocol development, assembly, and review of clinical trial documents. 

Experience Required / Requirements

• Previous clinical trial work / Phase I - II 
• Training clinical trial site staff
• IRB submissions
• Regulatory compliance
• Previous experience at NIH - Plus

Master's degree in relevant field ( Biology, Nursing, Neuroscience, Health admin, General Science, Cognitive Science, Biopsychology) 

Certifications & Licenses - Either 

• Association of Clinical Research Professionals Certified Professional (ACRP-CP)
• Association of Clinical Research Professionals (ACRP)
• Certified Clinical Research Professional (CCRP)
• Certified Clinical Research Coordinator (CCRC)
• Certified Clinical Research Associate (CCRA)

• Clinical Trial Management System (CTMS)
• Electronic Medical Records System
• Electronic Data Capture System

Benefits We Offer:

• 100% Medical, Dental & Vision Coverage for Employees
• Paid Time Off and Paid Holidays
• 401K match up to 5%
• Educational Benefits for Career Growth
• Employee Referral Bonus
• Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN)

Responsibilities

Daily:

• Develop and edit clinical research protocols and related documents (informed consent, etc.).
• Organize and attend regulatory protocol meetings/reports.

• Review and ensure protocols and consents meet regulatory requirements and formatting.
• Collaborate with staff on safety, regulatory, and monitoring aspects.
• Manage, track, and coordinate regulatory activities for study protocols.
• Maintain complete and up-to-date regulatory documentation for each trial.
• Coordinate and schedule monitoring and auditing visits.

Key Focus:

• Accuracy, consistency, and completeness of documents.
• Regulatory compliance and proper formatting.
• Collaboration and communication with research team and staff.

Apply, send your information and resume as soon as you can.

A recruiter will reach out to you to talk about the process.

Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals 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.

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 protect.