Clinical Protocol Architect

Goldbelt Apex LLC

Portsmouth (VA)

On-site

USD 85,000 - 95,000

Full time

6 days ago
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Job summary

Goldbelt Apex LLC, part of the Healthcare Technology Transformation Group, is seeking a Clinical Protocol Developer to provide technical and scientific support for investigator-initiated protocols and clinical trials at NMCP. This role partners with the PI to develop ideas from LOI to an ethical, IRB/IACUC-compliant protocol for execution at NMCP.

You'll work with physicians, government PIs, and research teams to prepare consent forms, perform literature reviews, coordinate regulatory

Qualifications

  • Master’s degree in biological or health sciences with 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 physicians/scientists in developing, writing and producing human and animal research protocols.
  • Coordinate submissions and regulatory reports for investigator-initiated trials.
  • Prepare informed consent statements and study documents.
  • Conduct literature reviews and draft scientific documents.
  • Support IRB/IACUC compliant protocol development.
  • Assist with study database development and data monitoring planning.
  • Collaborate with data management and clinical operations teams to transition projects.

Skills

Communication
Scientific writing

Education

Master's degree in biology/health sciences

Job description

Goldbelt Apex LLC, part of the Healthcare Technology Transformation Group, is seeking a Clinical Protocol Developer to provide technical and scientific support for investigator-initiated protocols and clinical trials at NMCP. This role partners with the PI to develop ideas from LOI to an ethical, IRB/IACUC-compliant protocol for execution at NMCP.

You'll work with physicians, government PIs, and research teams to prepare consent forms, perform literature reviews, coordinate regulatory

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