Scientific Program Coordinator

Overview

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 Operations Coordinator to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).

Technical Requirements:

• Provide project management for the day to day DAIDS protocol registration (PR) activities including but not limited to, coordinating and leading meetings, and discussions regarding all aspects of protocol registration.
• Serve as the main point of contact for all protocol registration activities for DAIDS.
• Serve as the primary reviewer of all protocol registration deliverables including but not limited to standard PR reports, PR notification messages, review and recommend approval to Federal Client of all Investigator or Records, and Clinical Research Site regulatory documentation that include IRB/EC documentation, Forms FDA 1572/DAIDS IoR Forms, and site-specific informed consent forms to ensure all applicable regulations are met.
• Serve as the co-lead for working groups and committees to communicate information regarding protocol registration policies and requirements.
• Manage and design all protocol registration related trainings for DAIDS including but not limited to e-training modules and present proposals/materials to the PR Team Leader for approval prior to implementation.
• Evaluate and identify issues that are or may be problematic related to protocol registration and recommend policy and procedural changes to improve operations to the DAIDS PR Team Leader prior to implementation.
• Serve as the primary PR Team reviewer of protocol registration-related reports and documents from contractors (SOPs, quarterly and annual progress reports, timelines, procedure changes, etc.).
• Coordinate and provide project management for the continued development of the DAIDS Protocol Registration System (DPRS) module in the DAIDS ES.
• Provide guidance, consultation and expert advice on regulations, policies and procedures to DAIDS staff and researchers and to domestic and international research organizations involved in DAIDS-sponsored research.
• Analyze and interpret regulations, policies and procedures and provide oral and written explanations and recommendations.
• Establish quality assurance standards and metrics for PR policies and procedures.
• Coordinate and communicate with other DAIDS, NIAID and NIH counterparts to ensure consistency and harmonization of regulatory procedures and strategies.
• Advise the PR Team Leader and DAIDS leadership on compliance with regulations, policies and procedures related to protocol registration.

Specific Qualifications:

• Master’s degree in a related field is required.
• Minimum of 3-5 years of experience in clinical research operations.

Benefits

• 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 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: careers@axleinfo.com

 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.