Hire Freelance Clinical Trial Protocol Writing Experts

Emil K.

Clinical research specialist with 10 years+ experience of designing and implementing complex clinical trial projects
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USD 75/hr
Master of Medical Science
Greece

Expert in clinical trial design, phase II/III infectious diseases research, LMIC settings, risk analysis, and trial project evaluations

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USD 75/hr
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Jigar P.

Medical writer with 7 years of experience in clinical research.
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USD 18/hr
M.Sc. in Microbiology
India

Many thanks for visiting my profile. I have a total of 7 years’ experience in the writing area. Specialized in CSR writing for BA/BE, PK/PD, Tr...

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USD 18/hr
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Dr. Shyam Nikethen G.

Medical writer with expertise in producing Regulatory compliant CSR, protocols and SAE reports and Summaries
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USD 10/hr
PharmD (Doctor of Pharmacy)
India

With immense knowledge on Adverse Drug Reaction(ADR) monitoring and reporting, patient care, counselling, prescription monitoring, drug interac...

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USD 10/hr
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Adil M.

Researcher/ Writer/ Fact Checker/Data Curator & Data analyst
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USD 20/hr
BSc (Hons) Molecular Genetics and Molecular Biology
Pakistan

Dear Employers, I am a Professional researcher, writer, fact-checker, and analyst with a Master's Degree in Molecular Biology. My natural...

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USD 20/hr
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ANATH L.

Founder/CEO at DADYMINDS
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USD 25/hr
NATIONAL TVET CERTIFICATE V
United States

5 years in research and writing as an influential author| Expert in business management and mental health services| Plus expertise in Global Br...

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USD 25/hr
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Dr. Souad M.

Clinical Operations, Clinical Trial Design, Regulatory Consulting, IND submission, Medical Writing
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USD 300/hr
PhD | Neuroscience
United States

I am a hard working and dedicated Clinical Researcher with 20 years of experience in clinical research in the fields of Neurology, Cancer, Card...

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USD 300/hr
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Dr. Sanjaya C.

Clinical Researcher/Medical Writer/Statistician with 7+ years of experience in health care industry
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USD 30/hr
MSc Medical Statistics
Nepal

I am a pro-active person trained in clinical pharmacology and biostatistics. Currently, I'm leveraging my clinician skills in the improveme...

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USD 30/hr
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Dr. Aissulu I.

Master of Medicine, Medical Doctor, the Lecturer at the Medical University with a deep experience in Clinical trial
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USD 100/hr
master of medicine
Kazakhstan

CT: oncology, infections, gastro, gynecology, diabetis

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USD 100/hr
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Dr. Wen Chean L.

Medical Writer/ Life Sciences and Healthcare Consultant, 10+ years research experience in Immunology and Oncology
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USD 50/hr
PhD in Infection, Inflammation and Immunity
Australia

I have a strong background in immunology and oncology, with over 10 years of research experience across academia and biotech/pharma. I possess ...

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USD 50/hr
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Dr. Daniel P.

Freelance Market Access Consultant for Pharmaceutical products (CH, A)
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USD 150/hr
Dr. med.
Croatia

Trained Physician with clinical and 10+ years of practical experience in Market Access and Life Cycle Management of pharmaceutical products in ...

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USD 150/hr
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Dr. Cynthia D.

Freelance medical and scientific writer with an expertise in biotechnologies, molecular biology and rare diseases.
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USD 80/hr
Doctorate
France

Freelance Medical and Scientific Writer with 4+ years experience in scientific writing Science Blog Writer and Editor (biologicallycurious.com)...

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USD 80/hr
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Syed Mohsin A.

Medical writer with 6+ years of experience in clinical research & SPSS expert
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USD 8/hr
Bachelors, Chemistry
United Kingdom

This is Mohsin, I am a professional Freelancer having extraordinary skills in writing, Marketing & graphic designing. Having 6+ years of ex...

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USD 8/hr
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Bailey A.

Freelance Medical Writer with experience in oncology clinical development and precision medicine
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USD 40/hr
United States

Experienced primarily in the field of oncology (adult and pediatric), in both academia and industry.

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USD 40/hr
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Andrew B.

Medical writer with 4+ years of experience in clinical evaluation
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USD 50/hr
Master of Public Health
United States

Technical writer with 3 years’ experience executing clinical-regulatory documentation and demonstrated knowledge of EU MDR, clinical evaluation...

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USD 50/hr
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Biomedical E.

MEDICAL DEVICE REGULATORY CONSULTANT EU-MDR | EU IVDR | SaMD | FDA | MHRA | SFDA | Germany | 7+ years’ Experience
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USD 30/hr
MS Biomedical Engineering
Pakistan

I am Umair Ahmed, a seasoned Biomedical Engineer and Scientist offering over 7 years of comprehensive experience in the freelance medical devic...

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USD 30/hr
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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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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 40100 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.