I will write gcp clinical trial protocols, sops, icfs, and csrs

Man Li

China

I speak English, Chinese

Clinical Research Associate GCP Clinical Trial Documentation Specialist

I am a Clinical Research Associate (CRA) with 5 years of experience across global pharmaceutical and CRO studies - oncology, diabetes, dermatology, ophthalmology and more. I help international clients...
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About this Gig

Phase II greenlit but your CRO needs audit-ready docs by week 6? I'm a former CRA II with 5 years across sponsor and CRO settings. I write GCP-compliant protocols, SOPs, ICFs, and CSRs that pass sponsor and auditor review first time no redlines, no 483s.


What you get:

- SOPs aligned with ICH E6(R2) GCP

- Clinical study protocols & amendments

- Investigator Brochures & Informed Consent Forms

- Clinical Study Reports per ICH E3

- Regulatory-ready templates (FDA 21 CFR Part 11 / EMA)


Why me: 5 years CRA experience in oncology, diabetes, dermatology, ophthalmology; former CRA II; Pharmaceutical Engineering background. Documents built to pass audit, not just look complete.


How it works: 1) You brief me 2) I draft in 2-4 days 3) You review 4) I finalize. Delivered as editable .docx with tracked changes.


Not sure what your submission needs? Message me your project stage - I'll recommend the document set and give a free timeline estimate within 24 hours.

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write gcp clinical trial protocols, sops, icfs, and csrs
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write gcp clinical trial protocols, sops, icfs, and csrs

Document type:

Standard Operating Procedures (SOPs)

+1 more

Language:

English

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