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Dr. Ahmed E.
An MD with an onging Ph.D. in Healthcare Data Analytics....I have extensive experience within the scope of scientific writing, peer-reviewed publications, advisory...
Dr. Maartje W.
I am a freelance medical and science writer with over 10 years of biomedical research and medical writing experience in oncology, immunology, a...
Dr. Muhammad Hashim G.
A doctor by profession, a researcher by passion & a staunch believer in the practice of evidence based medicine and clinical research, ...
Morgan B.
Freelance writer with over 7 years in clinical research. I've been involved in medical device trials, drug trials, investigator-initiated s...
Danielle K. B.
I am a clinical research professional with 6+ years of experience in the various therapeutic areas and industries including Respiratory, Anesth...
Cristal R.
I am a medical doctor holding a postgraduate in Principles and Practice of Clinical Research, accompanied by advanced expertise in biostatistic...
Dr. Adam S.
Experienced scientific and medical writer with expertise in clinical writing (clinical trial protocol, CSR, IB, ICF) and regulatory writing (IN...
Dr. Ana Carolina E.
PhD graduate with 6+ years of biomedical research experience in immunology, vascular biology and auto-immune diseases. Experience in phase III/...
Dr. JORDANA S.
B.S. in biomedicine, M.S. in physiological sciences, and Ph.D. student in pharmaceutical sciences. I have experience in preclinical and clinica...
Dr. Ana Luiza C.
I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...
Juan Manuel F.
Clinical Project Manager, Research and Development Technical Expert and University Lecturer. 9+ years in clinical research Studies: I have a b...
Dr. Hrishikesh G.
Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...
Dr. Scott A.
Medical affairs professional with 6 years of experience in the pharmaceutical and medtech industries and 10 years of experience in academic an...
Dr. Thor N.
I am a medical doctor, specialized in Family Medicine, with a degree in Clinical Pharmacology, and an MBA in Quality Administration. I worked i...
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Dr. Marijn L.
I have close to 20 years of experience in human neuropsychopharmacological research at the Department of Psychiatry and Behavioral Sciences. I ...
Dr. Diksha V.
I am a doctorate in life sciences with an experience of over 9 years in the academic and corporate sector. I have managed projects focusing on...
Dr. Ahram Q.
My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...
Krishna K.
Clinical Project Management and Medical Writing professional with 11+ years of experience in bio study activities including project planning, m...
I am working in a medical institute for 9+ years as faculty orthodontist. Currently, I am Associate Professor with responsibility including aca...
Dr. Kanika S.
I am a PhD-trained medical writer copyeditor with over 4 years of experience. I hold a graduate-level certification in Medical writing and edit...
GURUDATH G.
Entrepreneur, Design Thinking Master Practitioner & Human-centred Innovation enabler Clinical Research Leader with 8+ years of Project,...
Anjali S.
Performance-driven professional with total 2 decades of rich & extensive experience in Clinical Research & Development, Pharmac...
Joshita M.
A passionate researcher, with a Master’s degree in Biomedical Engineering from Carnegie Mellon University (USA), I have 9 years of product deve...
Alifiya T.
I am a research scientist/medical writer trained in clinical sciences, epidemiology and biostatistics (BDS, MPH, Rutgers University, USA). My p...
Rudra P.
We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...
Consult top freelance clinical trial protocol writing specialists with expertise in protocol development, clinical research writing, and more. Kolabtree is the world's largest platform for hiring trusted freelance clinical trial protocol writers.
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You will receive detailed proposals directly from Kolabtree. These proposals will include a comprehensive Statement of Work (SOW), project fees, milestones, and deadlines.
You can choose to pay either a fixed or an hourly fee based on your scope of work. Pre-pay for the next milestone. You have to approve the deliverables only if the quality meets your expectations. If you arn’t happy, we’ll refund your money.
Kolabtree will share multiple quotations for your project. You have the freedom to accept the quote that aligns with your project requirement and budget. You can get in touch with us in case you want to discuss the fee.
Our T&C include a default confidentiality clause that protects your IP and NDA for added protection.
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You have to approve the deliverables only if quality meets your expectations. If you arn’t happy, we’ll refund your money.
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Freelance clinical trial protocol services$400.00
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freelance clinical trial protocol writing services$550.00
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Looking for best clinical trial protocol solutions$400.00
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How to Hire an Expert in Clinical Trial Protocol Writing
All clinical trials for drugs and medical devices require the preparation of a clinical trial protocol, 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.
What Does a Clinical Trial Protocol Writer Do?
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.
How Much Does It Cost to Hire a Freelance Clinical Trial Protocol Writer?
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.
How Do You Write an Effective Job Post to Hire a Clinical Trial Protocol Writer?
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.
