Senior Human Subjects Compliance Scientist

General Dynamics Information Technology

Frederick (MD)

Hybrid

USD 85,000 - 101,000

Full time

12 days ago

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Benefits offered by this job

Hybrid schedule
Total rewards benefits

Job summary

General Dynamics Information Technology (GDIT) seeks an experienced Senior Human Subjects Protection Scientist to support the ORRC/OHRO within DHA R&D. The role ensures DHA-conducted and sponsored research complies with Federal, DoD, FDA, and international requirements.

The candidate will review protocols, identify regulatory deficiencies, and advise investigators and administrators. Hybrid work, strong regulatory expertise, and 9–5 core hours are expected.

Qualifications

  • Bachelor’s degree in a scientific or related discipline is required.
  • Knowledge of the Federal regulations governing human subjects protections (Common Rule, FDA).
  • Experience reviewing and editing DHA R&D protocol submissions for OHRO review.
  • Ability to apply DoD and DHA R&D human subjects protections policies.
  • Strong organizational skills and attention to detail.

Responsibilities

  • Provide regulatory-based written review of protocols using checklists.
  • Identify deficiencies and regulatory noncompliance in OHRO submissions.
  • Delineate issues and make recommendations to OHRO authorities.
  • Work with investigators to update materials for OHRO approval.
  • Manage portfolio of protocols, including data entry in OHRO systems.
  • Develop and update local procedures and guidance on human subjects protection.

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 Information Technology (GDIT) seeks an experienced Senior Human Subjects Protection Scientist to support the ORRC/OHRO within DHA R&D. The role ensures DHA-conducted and sponsored research complies with Federal, DoD, FDA, and international requirements.

The candidate will review protocols, identify regulatory deficiencies, and advise investigators and administrators. Hybrid work, strong regulatory expertise, and 9–5 core hours are expected.

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