I will create or review gcp compliant site documentation for clinical trials


About this gig
As a Clinical Project Manager with 3+ years of site-level experience supporting oncology, neuroscience, and cell therapy Phase I-III trials, I can provide high-quality clinical trial document writing and protocol summaries. I will support you or your team in strengthening your documentation, improve operational clarity, and ensure alignment with GCP and protocol requirements.
My support covers:
- Source documentation (SDs)
- Logs, trackers, and site tools
- SOPs, templates, and checklists
- Protocol summaries
- etc. Please feel free to request a specific service or document type based on your study needs.
Please reach out to me before ordering to discuss your project requirements and feasibility.
Get to know Olivier L.
PhD in Neuroscience
- FromCanada
- Member sinceJul 2020
- Avg. response time7 hours
- Last delivery2 years
Languages
English, French
FAQ
What types of clinical trial documents can you work on?
I can support most operational and site‑level documents, including source documentation, logs and trackers, workflow tools, SOPs, templates, and protocol‑driven study materials. If you have a specific document in mind, you can share it during the order and I will confirm feasibility.
Do you follow GCP and protocol requirements when reviewing or creating documents?
Yes. All work is aligned with Good Clinical Practice principles and the relevant sections of your protocol, SOPs, or sponsor guidelines. My goal is to ensure clarity, operational feasibility, and audit‑ready structure.
Can you help if I don’t have a template or if my site/sponsor doesn’t provide one?
Absolutely. I can create a clean, structured template based on your study needs, operational workflows, and industry standards.
Do you offer consulting beyond document creation or review?
Yes. I can provide operational recommendations, identify potential risks, and suggest improvements related to monitoring readiness, query management, documentation workflows, and site‑level processes.
What if my document exceeds the word count of the package I selected?
If your material slightly exceeds the package limit, I can usually accommodate it without any issue. For larger differences, I will suggest the most efficient option, either an upgrade or a small add‑on, so you only pay for what you truly need.
