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Introduction to Principles and Practice of Clinical Research
Pakistan
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USD 50/hr
A doctor by profession, a researcher by passion & a staunch believer in the practice of evidence based medicine and clinical research, ...He has done Professional Academic Writing, Public Health and Biostatistics Courses from Harvard University
USD 50/hr
MBA Quality Management
Brazil
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USD 50/hr
I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...
USD 50/hr
PhD
Canada
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USD 120/hr
I am a freelance medical and science writer with eight years of research experience in cancer immunotherapy. I obtained a MSc in pathobiology a..., communicating science with young students during volunteering activities, and writing for various publicationsmanaged several projects with national and international collaborators resulting in grant funding and publications
USD 120/hr
PhD in Electrical Engineering
United States
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USD 100/hr
Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...
USD 100/hr
Master in Business Administration
Mexico
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USD 45/hr
I am a medical doctor, specialized in Family Medicine, with a degree in Clinical Pharmacology, and an MBA in Quality Administration. I worked i...
USD 45/hr
MS
India
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USD 70/hr
We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...gt; Feasibility survey reports, disease demographics > Standalone QC and review of documents Publicationwriting services include: > Publication planning > Primary and secondary manuscript writing
USD 70/hr
MS - Biomedical Engineering
India
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USD 20/hr
A passionate lifelong student of Biomedical sciences with a Master’s degree from Carnegie Mellon University (CMU), I have always been fascinate...
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M. Sc - Clinical Research
India
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USD 100/hr
Entrepreneur, Design Thinking Master Practitioner & Human-centred Innovation enabler Clinical Research Leader with 8+ years of Project,...
USD 100/hr
Diploma
India
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USD 40/hr
•Specialist in Oral Medicine and Radiology and Diploma in Medical writing. •Over 7+ years of experience in teaching, research, academics, hospi...
USD 40/hr
Master of Science
India
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USD 40/hr
Biomedical researcher with 8 years of experience. A published author in the field of neuroscience (pain perception) and randomised controlled t...Recently submitted my PhD thesis in Physiology and counting down the days for my public defense.
USD 40/hr
Medical Degree (MD)
Canada
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USD 35/hr
Medical affairs professional with 4 years of experience in the pharmaceutical industry and 8 years of experience in academic and industry resea...
USD 35/hr
MPhil
Pakistan
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USD 10/hr
I have a degree in pharmaceutical science and a solid background in writing for various clients throughout my freelance writing experience. Whi...
USD 10/hr
MDS
Nepal
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USD 30/hr
I am working in a medical institute since 6 years as faculty orthodontist. Currently, I am Associate Professor with responsibility including ac...
USD 30/hr
Global SAS Certified Programmer
India
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USD 40/hr
15+ years experience working in Clinical research , Clinical data Management , Statistical Analysis & CDISC data preparation &...
USD 40/hr
Master of pharmacy (Pharmacology)
India
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USD 11/hr
I am Khushbu Pitroda, completed masters in pharmacy (Pharmacology) in 2015, Bachelor of pharmacy in 2013 and Diploma in pharmacy in 2010 from G...
USD 11/hr
Master degree in Science, Technology and Health
Vietnam
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USD 60/hr
EDUCATION: - Master in Science, Technology and Health - Sorbonne Université - France - Clinical Research Associate Certificate EXPERIENC...
USD 60/hr
Master of Public Health (Epidemiology & Biostatistics)
United States
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USD 10/hr
I am a research scientist/medical writer trained in clinical sciences, epidemiology and biostatistics (BDS, MPH, Rutgers University, USA). My p...
USD 10/hr
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Msc Clinical Research
India
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USD 350/hr
I have an experience in Research Projects planning, designing to execution in Cardiology, Gastrology, Neurology, Opthalmology, Oncology, Endoc...
USD 350/hr
PhD in Pharmacology (Pharmacoepidemiology)
Netherlands
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USD 70/hr
-Postdoctoral Researcher of Erasmus Medical Center, Rotterdam, Netherlands. -Postdoctoral Researcher at the Department of Clinical Pharmacolog...
USD 70/hr
PhD
Germany
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USD 50/hr
I bring to the collaborators an enthusiasm for creating knowledge with 15+ years of experience in the field of Biology, excellent project manag...
USD 50/hr
PhD - Pharmacology
Australia
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USD 90/hr
Medical/Scientific Affairs professional holding a Ph.D. degree in pharmacology with extensive academic and industry experience across various t...
USD 90/hr
PhD
Pakistan
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USD 75/hr
Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...
USD 75/hr
Doctor of Philosophy (Ph.D, Pharmaceutical sciences)
India
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USD 30/hr
I am a Doctorate (PhD) in Pharmacy, a Certified Medical Publication Professional™ (CMPP), a certified Information Mapping Professional™ (IMP) a...I am a Doctorate (PhD) in Pharmacy, a Certified Medical Publication Professional™ (CMPP), a certified
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PhD
United States
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USD 120/hr
I am an accomplished research scientist and group leader skilled in design of human and animal studies, in developing and reviewing IRB documen...
USD 120/hr
Medical Writing
United States
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USD 75/hr
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.... CONSORT guidelines for writing abstracts in scientific publications. Lay summaries following EUEnglish For scientific editing, I have experience working with ESL writers and can help in preparing a publication-ready
USD 75/hr
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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Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality clause. You can also sign NDAs and custom agreements with freelancers for additional protection.
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Clinical trials for FDA-licensed medical device$2100.00
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Multiplicity issues in clinical trial subgroup analysis$1000.00
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Find freelance Clinical Trial Protocol Writing experts by country
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.
Related skills
Skills related to Clinical Trial Protocol Writing
