Clinical trial protocols require input from a multi-disciplinary team of medical and operations professionals that may include the study sponsor, a clinician, a statistician, the clinical research coordinator, the project manager, and a medical writer. It is the medical writer’s role to incorporate all of these inputs into the final clinal trial protocol (CTP).

The responsibilities of a clinical trial protocol writer can include:

• Applying protocol content guidelines and templates
• Writing up the protocol synopsis and the full research protocol
• Researching published and unpublished medical and scientific data to support the study rationale and approach
• Working with the study sponsor and other team members to develop, review, revise, and finalize the clinical trial documentation
• Ensuring compliance of the protocol to regulatory and ICH guidelines
• Ensuring compliance of the protocol to IRB guidelines
• Preparing scientific and regulatory documents to support ongoing clinical research trials

 Experts in writing clinical trial protocols will typically be medical writers with several years of experience writing for a contract research organization (CRO), pharmaceutical company, or biotechnology company. They usually have a PharmD, MD, or a Master’s or Ph.D. degree in an allied scientific field. They will have extensive knowledge of the regulatory requirements relevant to their region (e.g., FDA or EMA), as well as the ICH guidelines.

Clinical trial protocol writers work either as freelance medical writers or for CROs, medical device or healthcare companies, clinical research consultancies, and pharmaceutical companies. The job titles of clinical trial protocol writing experts vary and can include Medical Writer, Research Medical Writer, Senior Medical Writer, Principal Medical Writer, Clinical Research Consultant, and Clinical Research Communications Specialist. While some may be generalists, others may specialize in e.g., biologics or medical device protocol writing.

To hire a freelance clinical trial protocol writer, the fee generally ranges from 40−100 USD per hour depending on the required skillset and the level of experience necessary.

The hourly fee can be negotiated upfront based on the estimated number of project hours, or a flat fee (for projects of a defined scope) can be discussed. If you need short-term/temporary access to these specialists, then hiring a freelance clinical trial protocol writer or clinical research consultant on our platform is a convenient and cost-effective way to harness their expertise.

The best way to attract the top Kolabtree freelancers in this field is to make your project description informative. You will need to provide information on the following:

• Skills required (e.g., expertise in writing medical device protocol writing)
• What the project area is (e.g., orthopedic devices)
• What the project entails (e.g., ensuring protocol compliance with EMA regulatory guidelines)
• What the deliverables are (be specific about what you need the outputs to be)
• Duration of the project (provide an estimate of how many hours work you will need per week/by when you need the project to be completed)
• By when you need to hire (having more leeway on this will give you more time to choose the best expert for your needs)
• Your budget (per hour or fixed fee)

If you are unsure what exactly is required, providing as much detail as possible will allow the experts to still make an informed bid for your project and suggest the best routes forward.

Our platform makes it easier than ever before to connect and collaborate with medical writers with experience in clinical trial protocols.

Hire Clinical Trial Protocol Writers by posting a project for free.