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Clinical Research Project Specialist

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On successful completion of this program, you will be certified and will have acquired knowledge, skills and competencies to start at an entry level role as Clinical Research Project Specialist or similar.
  • Level: Professional
  • Continuing Education Units: 100 contact hours, 10.0 CEUs
  • Certificates: GCP & VIARES

COURSE Content

Successfully complete the 10 competency modules below to obtain your VIARES Academy Certificate.
  • Background of medicines development
  • Research and discovery stage & product development
  • Clinical development
  • Regulatory submission, Health Technology Assessment, lifecycle management
  • ICH GCP and other applicable regulations
  • Applicable international and national regulations
  • ICH GCP E6 (R2)
  • FDA Regulation
  • Quality Assurance: Audits and Inspections
  • The Study Protocol
    • Elements of a Study Protocol according to ICH GCP
    • Trial Design
    • Methodologies
  • Roles and Responsibilities
    • Ethics Committees
    • Sponsor / Monitor
    • Investigator
    • Competent Authority
  • Patient Protection
    • Patient Information
    • Collecting Patient Consent
    • Special Patient Populations
  • Adverse Event Reporting
    • Types of Adverse Events
    • Identifying and Reporting Serious Adverse Events
  • Managing the Investigational Medicinal Product
    • Definition of investigational medicinal product (IMP) / study drug
    • Provision of the IMP
    • Drug Accountability
    • Randomization, blinding and un-blinding processes
    • Managing Expiry Dates
    • Collecting IMP after Site Close-out
  • Get familiar with project management terminology.
  • Define project success criteria.
  • Set up project phases correctly.
  • Choose fitting tools to manage a project.
  • Communicate efficiently while managing a project.
  • Understand typical differences between the PM’s role depending on the company type.
  • Understand the stakeholder landscape.
  • Analyse stakeholders.
  • Identify key stakeholders.
  • Communicate successfully with different stakeholders choosing adequate style, frequency, and the level of detail.
  • Understand the project external and internal environment.
  • Assess how the environmental factors affect the project.
  • Define requirements to make the project a success story.
  • Define the project scope.
  • Build a strong project definition.
  • Obtain the approval for your project definition.
  • Differentiate risks, constraints, and issues.
  • Identify project risks and decide on a suitable primary response strategy.
  • Analyse project risks in three dimensions – likelihood, impact, and detectability.
  • Quantify risks and calculate the Risk Priority Number.
  • Optimise conditions for high risks.
  • Monitor risks and keep them under control.
  • Assess the effectiveness of your risk management process.
  • Identify key stages of a project.
  • Analyse whether something is missing for a successful delivery (gaps).
  • Plan how to bridge the gaps.
  • Assign responsibilities to your team members.
  • Develop the clinical study budget.
  • Prepare a detailed realistic plan (baseline schedule) of the project including milestones, critical path, work breakdown, and allocated resources.
  • Use a well-designed baseline schedule to measure progress and manage the project in the execution phase.

VIARES CERTIFICATE

Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the course and your exam, you get your personal “Course Certificate” including:

  • course title
  • contact hours
  • continuing education units (CEU)
  • your overall course score
  • date of completion
  • personal certificate verification code
 

We also show you how to best share your certificate on LinkedIn and other social media platforms.

Obtaining a clinical project specialist certificate can provide several benefits for individuals who are interested in pursuing a career as a clinical project specialist. Some potential benefits of getting a clinical project specialist certificate include:

  • Demonstrating your knowledge and expertise: Earning a clinical project specialist certificate can demonstrate to employers and colleagues that you have the knowledge and expertise needed to plan, manage, and oversee clinical research projects.
  • Enhancing your career prospects: Having a clinical project specialist certificate can help you stand out in a competitive job market and increase your chances of landing a job as a clinical project specialist.
  • Meeting regulatory requirements: Some employers and regulatory agencies may require clinical project specialists to have a specific certification in order to work on clinical trials, and a clinical project specialist certificate can fulfill this requirement.
  • Improving your skills and knowledge: A clinical project specialist certificate program can provide opportunities to learn about the latest trends, best practices, and tools used in clinical research, which can help you improve your skills and knowledge in the field.

Overall, obtaining a clinical project specialist certificate can be a valuable investment in your career as a clinical research professional, and can help you stand out in a competitive job market while enhancing your skills and knowledge.

Delivered by industry experts

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Gabi Disselhoff

Regulatory & Quality Expert

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GAVIN CHAIT

Clinical Data Scientist

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KAMILA NOVAK

Clinical Project Management Guru

Hear from our graduates

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Phoebe

The VIARES Talent Program is a good opportunity for us who have been struggling for years to get accepted in the CRA opportunities/ roles. We have been able to acquire vast knowledge and in-depth skills on CRA roles. I appreciate the

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opportunity to take the ACRP ELKA after graduation of the CRA Talent Program.

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Joseph

VIARES has revolutionized trainings for Clinical Research Associates. Besides being standardized with industry focused content, the training is well structured and very detailed. The delivery and assessment of content is superb. Coming from Africa

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and a top class training I received at the Academy, I have what it takes to support both operations in the Pharma industry as well as CROs.

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WHY BECOME A Clinical Project SPECIALIST?

There are several reasons why you might want to consider becoming a clinical project specialist:

  • Rewarding work: As a clinical project specialist, you would be responsible for overseeing clinical trials and ensuring that they are conducted according to established protocols and guidelines. This work can be incredibly rewarding, as you would be playing an important role in helping to develop new treatments and cures for various health conditions.
  • High demand: The field of clinical research is growing, and there is an increasing demand for skilled clinical project specialists. This means that there are likely to be many job opportunities available to you if you choose to pursue this career.
  • Competitive salary: Clinical project specialists are typically well-paid, with a median annual salary of around $86,000 according to Payscale. However, it’s important to note that these figures are only a general guideline and may not reflect the specific salary that you would earn in your particular situation. Your salary may be influenced by factors such as the size and type of organization you work for, your level of experience, the type of clinical research you specialize in, and the geographic location of your employer.
  • Career growth: As you gain experience and expertise in the field, there may be opportunities for career advancement, such as moving into a leadership role or specializing in a particular area of clinical research.
  • Variety of work: Clinical project specialists work with a variety of stakeholders, including clinical investigators, study coordinators, and regulatory agencies. This can provide a diverse and interesting work experience.
 

Ultimately, if you are passionate about helping to develop new treatments and cures, enjoy working in a fast-paced and dynamic environment, and want a career with good job prospects and competitive pay, then becoming a clinical project specialist may be a great option for you.

WHAT ARE TYPICAL RESPONSIBILITIES OF A Clinical Project SPECIALIST?

The specific responsibilities of a clinical project specialist can vary depending on the organization and the nature of the clinical research being conducted. However, some typical responsibilities of a clinical project specialist may include:

  • Developing and implementing study protocols: Clinical project specialists are responsible for developing and implementing study protocols that outline the procedures, timelines, and requirements for conducting clinical trials.
  • Managing study timelines and budgets: Clinical project specialists are responsible for ensuring that clinical trials are completed on time and within budget. This includes managing study milestones and coordinating activities among study team members.
  • Recruiting and selecting study participants: Clinical project specialists may be involved in recruiting and selecting study participants, and ensuring that they meet eligibility criteria and are properly informed about the study.
  • Overseeing study conduct: Clinical project specialists are responsible for overseeing the conduct of clinical trials to ensure that they are conducted in compliance with relevant regulations and guidelines.
  • Analyzing study data: Clinical project specialists may be involved in analyzing study data and preparing reports for regulatory authorities, study sponsors, or other stakeholders.
  • Communicating with study team members and stakeholders: Clinical project specialists are often responsible for communicating with study team members and stakeholders, such as study sponsors, regulatory agencies, and ethics committees.
  • Ensuring safety and ethical standards: Clinical project specialists are responsible for ensuring that clinical trials are conducted in a safe and ethical manner, with particular attention to protecting the rights and safety of study participants.

 

Overall, clinical project specialists play a key role in the planning, execution, and oversight of clinical trials. They work closely with a range of stakeholders, from study participants to regulatory authorities, to ensure that clinical trials are conducted in a safe and effective manner, and that the results are properly analyzed and reported.

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IS THIS THE BEST OPTION FOR ME?

To become a clinical project specialist, you typically need to have a background in clinical research, along with relevant education and experience. The specific qualifications and requirements can vary depending on the employer and the nature of the position, but some typical educational and experiential requirements include:

  • A bachelor’s degree in a relevant field: Many employers prefer clinical project specialists to have a bachelor’s degree in a relevant field, such as clinical research, biology, pharmacology, or a related discipline.
  • Experience in clinical research: Clinical project specialists typically need to have experience in clinical research, either as a clinical trials associate (CTA), study coordinator, or in another related role. This experience can provide a strong foundation in the principles and practices of clinical research, and can help you develop the skills and expertise needed for a career as a clinical project specialist.
  • Knowledge of regulations and guidelines: Clinical project specialists need to have a thorough understanding of the regulations and guidelines that govern clinical research, including FDA/EMA regulations, ICH guidelines, and GCP guidelines.
  • Strong communication and project management skills: Clinical project specialists need to be effective communicators and project managers, with the ability to coordinate and manage complex projects involving multiple stakeholders.

Overall, a strong background in clinical research, combined with relevant education and experience, can help you develop the skills and expertise needed to pursue a career as a clinical project specialist.

If you are not sure if this is the right training for you, we are happy to help you make the right decision. Email us at academy@viares.com and we will contact you.

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NEW JOBS POSTED TODAY

This is a snapshot of the latest new entries from our full list of global clinical research jobs. Our list is updated and curated for you daily, adding hundreds of new jobs. Get full access with a VIARES account.

[viares_jobs-table-course filter=”Clinical Project Specialist”]

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Description

A Flexible Online Setup

You can start the training right away and complete it at your own pace. This training contains 100 hours of online material.
You do not need to wait for a kick-off date, you can start your training anytime  – as early as today if you wish.

Get Certified & Job Ready

On successful completion of this program, you will be certified and will have acquired knowledge, skills and competencies to start at an entry level role as Clinical Research Project Specialist or similar.

The VIARES Clinical Research Project Specialist program is more than just a training. It’s a life-changer!

Certificates:

  • VIARES, GCP

 

Life-time payment plan includes:

  • all benefits from the monthly payment plan with only one payment
  • PLUS – unlimited life-time access to your training course
  • PLUS – free download of your training course handouts for offline learning
 

Monthly payment plan includes:

  • registration fee
  • all online-training course material
  • online access to our learning management system
  • mini-exams during the training to test your knowledge
  • VIARES exam – 2 attempts included
  • personalized certificate upon completion
  • join career events at no cost
  • free access to our weekly updated global job list
  • apply to exclusive job offers
  • get your personal career coaching
  • any time free cancellation of monthly payment
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clinical research online course - clinical research project specialist

BESTSELLER

Clinical Research Project Specialist
Typical annual market salary:
$50,000 and above

Original price was: $ 259.90.Current price is: $ 169.90.

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This Course includes
  • Language - English
  • 1 Year access on any device
  • Online Exam & Certificate of Completion
  • Contact Hours and CEUs

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Original price was: $ 259.90.Current price is: $ 169.90.

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GAVIN CHAIT

Data Scientist at Whythawk

Gavin Chait is a Data Scientist at Whythawk, which specializes in integrated open data consulting, and training for open knowledge, freedom of information, and economic development projects. He spent more than a decade in economic and development initiatives in South Africa. He was a commercial director at the Open Knowledge Foundation, and led the implementation of numerous open data projects around the world. Gavin has twenty years of experience in teaching at all academic levels, and is a passionate advocate for knowledge development through open access to data and freedom of information.

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KAMILA NOVAK

certified Lead Auditor for ISO 9001:2015

Kamila Novak, MSc, has been involved in clinical research since 1995, having worked in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant in medical writing, auditing, training, project and risk management. She delivered dozens of courses in areas related to clinical research and project management. In August 2019, Kamila became a certified Lead Auditor for ISO 9001:2015. Kamila is a Core Team Member in the DIA GCP & QA, Clinical Research, and Project Management Communities.

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