Senior Human Subjects Protection Scientist - Hybrid

General Dynamics Corporation; Northern (KY); Hybrid; USD 85,000 - 101,000; Full time

Job summary

General Dynamics Corporation seeks a Senior Human Subjects Protection Scientist to support DHA R&D OHRO at Fort Detrick, in a hybrid schedule.

The role performs regulatory reviews of research protocols, ensures compliance with Federal, DoD, FDA requirements, and coordinates with IRBs and investigators to address deficiencies. Strong knowledge of the Common Rule and related regulations is essential.

Qualifications

• Experience: 3+ years of related human subjects' protection experience
• Knowledge of Federal, DoD, FDA regulations and the Common Rule to oversee DHA R&D reviews
• Ability to manage a portfolio of protocol reviews and provide guidance to investigators
• US citizenship is required and security considerations apply

Responsibilities

• Provide regulatory-based written review of protocols using standardized checklists to ensure compliance with applicable regulations
• Review research protocols and delineate deficiencies and regulatory noncompliance; advise OHRO authorities on issues and coordinate updates with investigators
• Manage a portfolio of protocols including determinations for exempt/non-exempt and cadaver-related studies
• Provide information and documents to customers and OHRO personnel in a timely, professional manner
• Maintain OHRO information systems tracking of protocol reviews and activities
• Assist in developing policies, procedures, and guidance for OHRO and DHA R&D compliance
• Contribute to local procedures and guidance for OHRO operations and review guidelines
• Educate investigators and staff on human subjects protection requirements and regulatory policies

Skills

Human Subjects Research

IRB Protocol

IRB Submission

Research Protocols

Education

Bachelor's Degree in a scientific, or related discipline

Tools

Microsoft Office Suite

Job description

General Dynamics Corporation seeks a Senior Human Subjects Protection Scientist to support DHA R&D OHRO at Fort Detrick, in a hybrid schedule.

The role performs regulatory reviews of research protocols, ensures compliance with Federal, DoD, FDA requirements, and coordinates with IRBs and investigators to address deficiencies. Strong knowledge of the Common Rule and related regulations is essential.