Phase I Protocol Writer

I am preparing a first-in-human Phase I clinical study and need a seasoned medical writer to craft the full clinical study protocol from scratch. The assignment is narrowly focused on this single document—no trial reports or regulatory submission packages are required right now—so I’m looking for someone who lives and breathes ICH-GCP guidance, FDA expectations, and common-sense clarity. You will receive the investigational product overview, preliminary pre-clinical data, and our draft synopsis. From there, I need you to turn that core information into a polished, inspection-ready protocol that covers objectives, endpoints, study design, inclusion/exclusion criteria, safety monitoring, PK/PD sampling schedules, statistical considerations, and our standard appendices. I expect the tone and structure to follow current templates accepted by major U.S. IRBs. Because timing is tight, I’d like our first call within 48 hours of kickoff, a complete first draft in about ten days, and a clean, submission-ready version within twenty. Collaboration will be through tracked-changes Word files and brief Zoom touch-points; I’ll consolidate team feedback between rounds so you can stay focused on writing rather than logistics. Deliverables: • Microsoft Word Phase I protocol (core text + appendices) • A change-log summarising all revisions between drafts • End-of-project style sheet for future consistency Acceptance criteria: • Document aligns with ICH-E6(R2) and relevant FDA Phase I guidance • All sections internally cross-referenced and paginated correctly • Readability score on par with typical sponsor protocols (plain-language where possible without sacrificing rigour) Preference goes to writers who can point to at least two recent Phase I protocols you authored or led. Familiarity with oncology is a bonus, but solid Phase I experience in any therapeutic area is what really matters.

Project ID: 40455622

Location: New York, United States