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Consult top freelance clinical trial protocols specialists with expertise in protocol development, clinical research writing, and more. Kolabtree is the world's largest platform for hiring trusted freelance scientsts and consultants.
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Clinical trials for FDA-licensed medical device$2100.00
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All clinical trials for drugs and medical devices require the preparation of a , which is a document describing the trial rationale, objectives, design, organization, and methodology, as well as ethical and statistical considerations. Clinical trial protocols need to adhere to the guidelines for Good Clinical Practice (GCP) according to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). These documents also need to conform to the requirements of the relevant regulatory agencies (e.g., FDA, EMA) and institutional review board (IRB), who apply rigorous review before the trial sponsor being allowed to conduct the study.
Investing time and expertise into developing a good research protocol that is compliant and scientifically sound is critical to the success of the entire trial, and it can save a lot of time and expense in the long run. It can avoid the trial being put on hold or requiring timeline extensions, or worse yet, generating inconclusive data and resulting in trial failure.
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- Researching published and unpublished medical and scientific data to support the study rationale and approach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.