Clinical Protocol Architect: Trials & Regulatory

Goldbelt, Inc.; Portsmouth (VA); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company matching

Paid time off

Professional development opportunities

Job summary

Goldbelt Apex, part of the Healthcare Technology Transformation Group, seeks a Clinical Protocol Developer to support investigator-initiated protocols and clinical trials at NMCP. You will collaborate with the PI to develop ethical, IRB/IACUC-compliant protocols from LOI to execution.

The role involves drafting human and animal research protocols, coordinating regulatory submissions, and ensuring quality design aligned with DoD standards, under final Government approval.

Qualifications

• Masters degree in biological/health sciences with 3+ years of relevant research experience.
• Experience drafting human and animal research protocols and coordinating regulatory submissions.
• Knowledge of DoD ethics and compliance standards and IRB/IACUC processes.

Responsibilities

• Develop, write and produce human and animal research protocols NMCP CID and GME.
• Coordinate regulatory submissions and amendments with government PIs and ensure final approvals.
• Prepare informed consent statements and study documents for IRB/DOD compliance.
• Perform literature reviews and draft scientific and technical documents.
• Support SRC/IRB queries and ARC submissions under COR guidance.
• Assist with eIRB system updates and study development tracking.
• Collaborate with data management and clinical operations to transition projects to operations.

Skills

Communication skills

Scientific/Technical writing

Interpersonal skills

Education

Masters degree in biological/health sciences

Job description

Goldbelt Apex, part of the Healthcare Technology Transformation Group, seeks a Clinical Protocol Developer to support investigator-initiated protocols and clinical trials at NMCP. You will collaborate with the PI to develop ethical, IRB/IACUC-compliant protocols from LOI to execution.

The role involves drafting human and animal research protocols, coordinating regulatory submissions, and ensuring quality design aligned with DoD standards, under final Government approval.