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 provides a robust benefits program to all full-time employees, including:

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)

Overview

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), Office for Policy in Clinical Research Operations (OPCRO).

Responsibilities

• Provide human subject protections related advice and guidance on protocols and associated documents on COVID-related studies, including ACTIV-2.
• Participate in PSRC and CSRC and full regulatory reviews as applicable, and provide advice on human subject protections-related aspects of the protocol under review.
• Provide advice on human subject protections-related aspects of the protocol and related documents throughout the lifecycle of the protocol.
• Possess and maintain knowledge of pertinent human subject protections regulations including Office for Human Research Protections (OHRP), Food and Drug Administration (FDA) regulations, ICH guidelines, and any other applicable laws, regulations, policies, and guidance’s
• Advise the protocol team on complex issues involving human subject protections.
• Participate in team calls, branch meetings and other meetings, as requested.
• Contribute to and participate in inspection preparedness activities.
• Maintain up-to-date knowledge of regulatory and policy changes, including new and existing guidance documents on human subject protections.
• Interpret human subject protection regulations and policies in a clear and consistent manner.
• Communicate new information related to human subject protections and policies to Branch Chief, other DAIDS staff and stakeholders.
• Advise the branch chief and the OPCRO Director of any significant/relevant changes to the requirements that relate to human subject protections.
• Provide advice to inform the departmental Branch Chief of activities related to assigned tasks; perform project management, and related administrative tasks.
• Provide status updates and recommendations to the departmental Branch Chief, such as, on resolution of issues, etc.
• Develop briefings for the protocol team, departmental Branch Chief, OPCRO leadership and/or other DAIDS’ leadership, as requested.

Experience Required / Requirements

• Minimum of a Master’s Degree and a least 3 years of relevant of experience years in the field of human subject protection and policy development.

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)

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Bethesda, MD 20892: Reliably commute or planning to relocate before starting work (Required)

Education:

• Master's (Required)

Experience:

• Human Subject Protection: 3 years (Required)
• Regulatory Reviews: 3 years (Required)

Work Location: Hybrid remote in Bethesda, MD 20892

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