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Hire a Clinical trial protocols Expert

Dr. Ana Luiza Cassin Duz

Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
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$50.00/hr
MBA Quality Management
Brazil

I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...

$50.00/hr
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Joshita Majumdar

Biomedical Engineer, CMU | Product Manager & Medical Writer | Expert in Clinical Research with 6+ years of experienc...
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$20.00/hr
MS - Biomedical Engineering
India

A passionate lifelong student of Biomedical sciences with a Master’s degree from Carnegie Mellon University (CMU), I have always been fascinate...

$20.00/hr
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Dr. Ritesh Khandelwal MScCR, PGDPL, PGDCRM, CCCR, BPharm

Clinical Research Professional with 11+ yrs. of experience in Clinical Trials, Medical Writing, Statistical Analysis CDM
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$350.00/hr
Msc Clinical Research
India

I have an experience in Research Projects planning, designing to execution in Cardiology, Gastrology, Neurology, Opthalmology, Oncology, Endoc...

$350.00/hr
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Dr. Tanima Bose

Freelance ocular immunologist & Data Analyst | Expert in scientific writing with 10+years of experience.
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$50.00/hr
PhD
Germany

I bring to the collaborators an enthusiasm for creating knowledge with 15+ years of experience in the field of Biology, excellent project manag...

$50.00/hr
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Dr. Sam Mathew

Certified and experienced professional medical/scientific writer with 18 years of experience
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$30.00/hr
Doctor of Philosophy (Ph.D, Pharmaceutical sciences)
India

I am a Doctorate (PhD) in Pharmacy, a Certified Medical Publication Professional™ (CMPP), a certified Information Mapping Professional™ (IMP) a...

$30.00/hr
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Dr. Mary Ritchey

Experienced real-world researcher, generating evidence from clinical data for medical devices and pharmaceuticals.
PhD, Epidemiology
United States

Mary Beth Ritchey, PhD, FISPE has spent more than 15 years in government, industry, consulting, and academia in better understanding medical pr...

Dr. Rajesh Gyawali

Medical Researcher and Journal Editor | Expert in clinical data analysis
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$30.00/hr
MDS
Nepal

I am working in a medical institute since 6 years as faculty orthodontist. Currently, I am Associate Professor with responsibility including ac...

$30.00/hr
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K Latha

Doctor with 15+ years of experience in clinical research
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$100.00/hr
MD
India

Am a physician with more than 15 years of experience in the field of Clinical Research having expertise in Clinical trials, Medical review, Med...

$100.00/hr
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Edward Lisberg, MD FCCP CPI

30 years Principal Investigator I Clinical Trials Design & Implementation Consultant I Allergy/Respiratory MD FCCP ...
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$350.00/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...

$350.00/hr
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Rachel Parker

Freelance Clinical Protocol Design and Analyst | MS Translational Pharmacology spec. Clinical Trials
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$25.00/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...

$25.00/hr
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Alifiya Tahir

Clinical Research Scientist & Medical Writer with 5+ years of experience in academia & pharmaceutical industry
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$10.00/hr
Master of Public Health (Epidemiology & Biostatistics)
United States

I am a research scientist/medical writer trained in clinical sciences, epidemiology and biostatistics (BDS, MPH, Rutgers University, USA). My p...

$10.00/hr
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Rajesh Komma

A medical doctor with rich clinical research and medical writing experience. Expert at writing scientific documents.
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$50.00/hr
MD Pharmacology
Canada

Expert in writing scientific information, evaluating drug molecules and therapy area, writing medico-regulatory documents.

$50.00/hr
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Dr. Waqar Latif Butt

Auditing, Consulting, Training and Operations Management for International Standards i.e. ISO, BSCI, DIN, MDD, MDR, PPE
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$75.00/hr
PhD
Pakistan

Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...

$75.00/hr
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Rahul Agrawal

Medical Writer, Pharmacist & Biomedical Engineer. 12 years of research experience from around the globe
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$90.00/hr
Master of Science
Canada

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

$90.00/hr
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Alexander Baldridge, CCRA

Early Phase Oncology, Expert in Trial Management, Client Relations, Site Relations, 12 years experience
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$250.00/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...

$250.00/hr
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QUYNH NGUYEN

Medical Writer - Medical Device Consultant - Clinical Evaluation Report - MDD/ MDR/ MEDDEV
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$60.00/hr
Master degree in Science, Technology and Health
Vietnam

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

$60.00/hr
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Puneet Mittal

Leading CRO that help to run your clinical study as per ICH-GCP Guidelines, within Timelines, and limited budget
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$100.00/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...

$100.00/hr
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Hire top freelance clinical trial protocol writers for help with clinical trial documents and medical writing. Post your project securely and get quotes for free. Kolabtree is the world's largest platform for hiring trusted freelance scientists and consultants on demand.

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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.

Related skills

 

Clinical Research          Clinical Trials Drug Development          FDA Submissions                         Medical Device              Medical Sciences                                                                               Technical Writing           Product Development                           Regulatory Writing            Medical Writing          Pharmaceutical Industry 

 

Skills related to Clinical Trial Protocol Writing