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Top Freelance Clinical Trial Protocols Specialists For Hire | Kolabtree

Dr. Hrishikesh Gadagkar

Over 28 years of experience commercializing medical devices for large, mid-size and early stage companies.
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USD 100/hr
PhD in Electrical Engineering
United States

Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...

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USD 100/hr
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Dr. Thor Nissen Torres

Medical Consultant with 25+ years generating medical information for mutually agreed projects within the health area.
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USD 45/hr
Master in Business Administration
Mexico

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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USD 45/hr
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Rudra Patel

Group of Clinical Research Professionals (Project Manager, Biostatisticians, CRAs, Medical Writers, SAS Prgmers)
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★★★★★
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USD 70/hr
MBA
India

We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...

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USD 70/hr
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Mamoona Jav

Systematic review Consultant / Research Reviewer for ISPOR & Cochrane / Manuscript writing specialist / Research Ana...
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USD 100/hr
MSc Epidemiology and BioStatistics
United Kingdom

Specialist research and data analyst with a demonstrated history of working in the commercial business and healthcare industry. A motivated and...

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USD 100/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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USD 10/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...

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USD 10/hr
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Dr. Ana Luiza Cassin Duz

Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
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USD 50/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 ...

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USD 50/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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USD 20/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...

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USD 20/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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USD 350/hr
Msc Clinical Research
India

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

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USD 350/hr
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Dr. Payam Peymani

Pharmacoepidemiologist and Data Analyst/Expert in Pharmacovigilance,Clinical Trial, SPSS/R Software,Scientific Writing
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★★★★★
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USD 70/hr
PhD in Pharmacology (Pharmacoepidemiology)
Netherlands

-Postdoctoral Researcher of Erasmus Medical Center, Rotterdam, Netherlands. -Visiting scholar at the Department of Clinical Pharmacology &...

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USD 70/hr
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Dr. Pari Jafari

Scientific Advisor with PhD and 10+ years of global experience in Medical Device, Pharma, Clinical Research Organisation
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USD 90/hr
PhD - Pharmacology
Australia

Medical/Scientific Affairs professional holding a Ph.D. degree in pharmacology with extensive academic and industry experience across various t...

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USD 90/hr
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Dr. Rajesh Gyawali

Medical Researcher and Journal Editor | Expert in clinical data analysis
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USD 30/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...

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USD 30/hr
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GURUDATH GURJAL

Freelance clinical research leader and project/program manager - 13+ years of experience
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USD 100/hr
M. Sc - Clinical Research
India

Entrepreneur, Design Thinking Master Practitioner & Human-centred Innovation enabler Clinical Research Leader with 8+ years of Project,...

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USD 100/hr
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Ami Desai

Statistician & Data Analyst | Expert in SAS ,R & PYTHON |Owns SAS Software Licence 9.4 | 15+ years of exp in Cli...
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★★★★★
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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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Dr. Tanima Bose

Freelance ocular immunologist & Data Analyst | Expert in scientific writing with 10+years of experience.
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★★★★★
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USD 50/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...

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USD 50/hr
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Dr. Mary Ritchey

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

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Dr. Sam Mathew

Certified and experienced professional medical/scientific writer with 18 years of experience
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USD 30/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...

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USD 30/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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USD 75/hr
PhD
Pakistan

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

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USD 75/hr
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Dr. Kanika Sharma-Mittra

Certified Medical/Scientific Writer and editor
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USD 75/hr
Medical Writing
United States

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...

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USD 75/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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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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K Latha

Doctor with 15+ years of experience in clinical research
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USD 100/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...

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USD 100/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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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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Rachel Parker

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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Alexander Baldridge, CCRA

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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QUYNH NGUYEN

Medical Writer - Medical Device Consultant - Clinical Evaluation Report - MDD/ MDR/ MEDDEV
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USD 60/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 60/hr
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Naresh Sutar

Medical and Scientific Writing || Clinical Research || Drug Safety || Scientific Editing || Scientific Consultant ||
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USD 50/hr
Masters in Pharmacology
India

Regulatory Writing: Clinical Study Report, HA Responses, Literature reviews, Narrative writing, NDA-AR, IND-AR, CO and NCOs, Protocol, Investi...

★★★★★
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USD 50/hr
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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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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