Hire Freelance Clinical Trial Protocol Writing Experts

Dr. Tatiana M.

Medical writer with 14+ years of experience in clinical research.
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USD 65/hr
Doctor of Medicine (MD)

Medical writer specializing in clinical protocol development, informed consent form (ICF) creation, case report form (CRF) design, investigator...

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USD 65/hr
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Dr. Harsh V.

Medical/Scientific/Regulatory/Newsletter/CMC/Dossier/Research/Review/Thesis/Protocol/Report/Article writing & editin...
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USD 30/hr
PhD
India

A competent pharma professional with experience in Scientific writing, Regulatory competitive intelligence, DRA, F&D, MSAT and QA. Experie...

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USD 30/hr
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Courtney W.

Writer/ Health Research /Community Health Professional
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USD 50/hr
Masters of Science
United States

M.S. Health Science (Health Administration- Community Health Education and Promotion); 20+ years of human subject (clinical...trials) and community-based participatory research (behavioral; violence prevention, senior health; public...

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USD 50/hr
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Alexander B.

Early Phase Oncology, Expert in Trial Management, Client Relations, Site Relations, 12 years experience
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USD 250/hr
BS - Molecular Biology
United States

I have 12 years experience, starting as a Lead Coordinator at a clinical research site. Worked in the CRO space in study start-up, as a CRA, Cl...

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USD 250/hr
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Juan Manuel F.

Clinical Project Manager, Research and Develop. Technical Expert and University Lecturer. 9+ years in clinical research
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USD 25/hr
Master in Project Management
Spain

Clinical Project Manager, Research and Development Technical Expert and University Lecturer. 9+ years in clinical research Studies: I have a b...

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USD 25/hr
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Ami D.

Statistician & Data Analyst | Expert in SAS ,R & PYTHON |Owns SAS Software Licence 9.4 | 15+ years of exp in Cli...
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USD 40/hr
Global SAS Certified Programmer
India

15+ years experience working in Clinical research , Clinical data Management , Statistical Analysis & CDISC data preparation &...

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USD 40/hr
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Puneet M.

Leading CRO that help to run your clinical study as per ICH-GCP Guidelines, within Timelines, and limited budget
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USD 100/hr
Immune System- Research
India

MGCTS.ORG is a Contract Research Organisation that works for drug development across the world with major clients in Europe, Asia and Africa. W...

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USD 100/hr
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Pradip F.

R & D Expert, Scientific Advisor/Strategist/consultant with >20 years of experience in Lifesciences and Healthcar...
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USD 30/hr
M.Sc.
India

I am managing R & D project for in-vitro diagnostics, in-vitro drug screening, medical device, and vaccine development. I look into all as...

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USD 30/hr
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Rahul A.

Medical Writer, Pharmacist & Biomedical Engineer. 12 years of research experience from around the globe
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USD 90/hr
Master of Science
Canada

I have 12 years of research experience in fields of oncology, cardiology, orthopedics, biomaterials, tissue engineering, drug delivery, materia...

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USD 90/hr
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Lini S.

Regulatory Affairs Expert with 20 Years Experience (Regulatory and Scientific Writing Services)
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USD 90/hr
MSc Pharmaceutical Chemistry
India

Specialities - Well-versed in EU Registration procedures (DC/MR, CP and nationals). - CMC Dossier Development & writing - Regulatory St...

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USD 90/hr
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Khushbu P.

Regulatory affairs (eCTD submission) with 3+ years of experience. Working as freelancer for PharmaLex (PDE compilation)
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USD 11/hr
Master of pharmacy (Pharmacology)
India

I am Khushbu Pitroda, completed masters in pharmacy (Pharmacology) in 2015, Bachelor of pharmacy in 2013 and Diploma in pharmacy in 2010 from G...

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USD 11/hr
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Poornima M.

Scientific and medical writer with 11+ years clinical writing experience
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USD 30/hr
Master in Pharmacy
India

I am a Masters in Pharmacy specialising in pharmaceutics and drug formulation science from Rajiv Gandhi University of Health Sciences, Bangalor...

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USD 30/hr
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Rachel P.

Freelance Clinical Protocol Design and Analyst | MS Translational Pharmacology spec. Clinical Trials
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USD 25/hr
BS Computer and Information Science
United States

Clinical Research Experience: The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center Masters of Science (The...

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USD 25/hr
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QUYNH N.

Medical Writer - Medical Device Consultant - Clinical Evaluation Report - MDR/ Performance evaluation IVDR
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USD 150/hr
Master degree in Science, Technology and Health
Vietnam

EDUCATION: - Master in Science, Technology and Health - Sorbonne Université - France - Clinical Research Associate Certificate EXPERIENC...

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USD 150/hr
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Edward L.

30 years Principal Investigator I Clinical Trials Design & Implementation Consultant I Allergy/Respiratory MD FCCP ...
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USD 450/hr
Research Fellowship, Allergy/Immunology
United States

I have served as PI for over 160 phase 2 and 3 respiratory disease clinical trials, designed and implemented clinical trials protocols, trained...

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USD 450/hr
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Mariangela M.

Medical Writer, Science Communication, PhD in Experimental and Molecular Oncology
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USD 15/hr
Specializzation in Food Science
Italy

Deep experiece in molecular oncology, NGS, Clinical Research and data management. Autonomy, flexibility, organization and interpersonal skills.

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USD 15/hr
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Viky Gilles Daniel V.

Global Regulatory Affairs Consultant - FDA - Medical Device - Pharma
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USD 150/hr
Global Regulatory Affairs Certification
United States

Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by ...

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USD 150/hr
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Hafsa A.

Clinical Pharmacist Researcher looking forward to establishing professional relationship through freelance Writing!
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USD 41/hr
Masters of Science
United States

PharmD professional, with over 4 years of clinical research experience in developing research projects, data collection tools, analyzing data a...

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USD 41/hr
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Omar F.

Clinical Research Scientist, Freelance Medical writer, Clinical specialist, Medical writer with 2+ years of experience.
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USD 10/hr
MS in Biochemistry and Molecular Biology
Bangladesh

I am a research scientist/medical writer trained in clinical sciences. I have worked on phase-I of clinical trials in the pharmaceutical indust...

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USD 10/hr
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Jessica B.

Global Project Leader in CNS | 10+ years of experience in clinical research | ACRP Certified
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USD 50/hr
Master of Science in Clinical Mental Health Counseling
United States

Global Project Leader in Psychiatry & Neurology. Former Research Scientist in Psychiatry. Experienced ACRP Certified Clinical Research Coor...

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USD 50/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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Nazmul H.

Freelance researcher | Expert in cell based therapeutics | 15+ years of experience in academic writing and publishing
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USD 20/hr
PhD
Bangladesh

Experienced cell and molecular biologist specialized in the production of cell-based and cell-free therapeutics. More than ten years of researc...

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USD 20/hr
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Smadar K.

Molecular biologist & cancer researcher with 10 years of training and expertise in translational cancer research.
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USD 35/hr
PhD in Biology
Australia

10 years of post-PhD experience that includes project management, expertise in patient-tailored assay development, best practice human specimen...

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USD 35/hr
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Laura F.

Commercial Enablement Leader | Strategic Market Analyst | Expert Launching HighSpot
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USD 190/hr
Bachelors
United States

Results-driven commercial enablement leader with 20 years of healtcare-related experience in marketing, sales, training and product management....

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USD 190/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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Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality and NDA clause.

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.

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Our T&C include a default confidentiality clause that protects your IP and NDA for added protection.

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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.