Senior Human Subjects Compliance Scientist

General Dynamics Information Technology, Inc.; Frederick (MD); Hybride; USD 85 000 - 101 000; Plein temps

Avantages offerts par ce poste

AI career tool

Internal mobility

Benefits package

401K match

Résumé du poste

General Dynamics Information Technology, Inc. is seeking a Senior Human Subjects Protection Scientist to support the DHA R&D Office of Research and Regulatory Compliance.

The role focuses on regulatory-based protocol reviews, adherence to DoD and FDA requirements, and interactions with investigators and IRB teams. Responsibilities include managing a protocol portfolio, updating documents for OHRO approvals, and contributing to policy development.

Qualifications

• Bachelor’s Degree in a scientific discipline and 3+ years of related human subjects protection experience.
• Knowledge of Federal regulations governing human subjects protection including the Common Rule and FDA regulations.
• Excellent communication, organizational, and problem-solving abilities.

Responsabilités

• Provide regulatory-based written review of protocols to ensure compliance with applicable regulations.
• Review protocols approved by local IRB and identify deficiencies for OHRO approvals.
• Work with investigators to update materials for OHRO approval.
• Manage a portfolio of protocols, including determinations for various research types.
• Provide information and documents to customers and OHRO personnel professionally and promptly.
• Enter data and use OHRO information systems to track protocol review activities.
• Assist in developing policies and guidelines for OHRO and DHA R&D compliance.
• Contribute to local procedures for OHRO and DHA R&D human subjects protection.
• Educate investigators and staff on regulations and OHRO requirements.

Connaissances

Regulatory knowledge

Common Rule

FDA regulations

IRB experience

Microsoft Office

Communication skills

Formation

Bachelor’s degree in a scientific discipline

Outils

OHRO information systems

Description du poste

General Dynamics Information Technology, Inc. is seeking a Senior Human Subjects Protection Scientist to support the DHA R&D Office of Research and Regulatory Compliance.

The role focuses on regulatory-based protocol reviews, adherence to DoD and FDA requirements, and interactions with investigators and IRB teams. Responsibilities include managing a protocol portfolio, updating documents for OHRO approvals, and contributing to policy development.