Clinical Protocol Architect

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Paid time off

Professional development opportunities

Job summary

Goldbelt Apex, LLC seeks a Clinical Protocol Developer to provide technical and scientific support for investigator-initiated protocols and clinical trials at NMCP. You will partner with the PI to develop ideas from LOI to IRB/IACUC-compliant protocols ready for execution at NMCP.

You will coordinate with government PIs, manage regulatory submissions, and ensure high-quality research design and ethics standards across human and animal studies.

Qualifications

• Master's degree in a biological/health science or related field.
• 3 years of relevant research experience.
• Ability to communicate effectively with senior Government, clinical, scientific, contracting, and research stakeholders.
• Excellent scientific, technical, written, verbal, organizational, and interpersonal communication skills.

Responsibilities

• Assist in developing, writing and producing human and animal research protocols and related documents for NMCP CID and GME.
• Coordinate investigator-initiated trials, amendments, and regulatory reports with Government approval.
• Prepare informed consent statements and study-related documents for approval processes.
• Conduct literature reviews and draft technical documents.
• Assist with ethical and compliance standards to meet DOD requirements in protocol development and updates.
• Support study registration on clinicaltrials.gov and coordinate QA reviews with PIs.

Skills

Communication

Scientific writing

Education

Master's degree in biological/health science

Job description

Goldbelt Apex, LLC seeks a Clinical Protocol Developer to provide technical and scientific support for investigator-initiated protocols and clinical trials at NMCP. You will partner with the PI to develop ideas from LOI to IRB/IACUC-compliant protocols ready for execution at NMCP.

You will coordinate with government PIs, manage regulatory submissions, and ensure high-quality research design and ethics standards across human and animal studies.