Clinical Research Project Specialist

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.

COURSE Content

Successfully complete the 10 competency modules below to obtain your VIARES Academy Certificate.

Medicines Development Process, Good Clinical Practice

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

Regulatory Environment in the EU and USA

Applicable international and national regulations
ICH GCP E6 (R2)
FDA Regulation
Quality Assurance: Audits and Inspections

Clinical Trial Design & Clinical Research Roles and Responsibilities

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 & Adverse Events

Patient Protection
- Patient Information
- Collecting Patient Consent
- Special Patient Populations
Adverse Event Reporting
- Types of Adverse Events
- Identifying and Reporting Serious Adverse Events

Investigational Medicinal Product Management

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

Project Management Basics

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.

Stakeholder Management

Understand the stakeholder landscape.
Analyse stakeholders.
Identify key stakeholders.
Communicate successfully with different stakeholders choosing adequate style, frequency, and the level of detail.

Project Conception and Definition

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.

Project Risk Management

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.

Project Planning

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.

Project Critical Path and Baseline Schedule

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

Hear from our graduates

Michela

It was a great opportunity for me taking part in the VIARES clinical research talent program to build and upgrade my clinical research skills.

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VIARES ACADEMY has played an incredible role, with the opportunity to be enrolled in such extraordinary, structured, well-organized, and dynamic training programs, led by Clinical Research Professionals.
The modular approach, combined with assignments and quizzes at the end of each module keeps the attendees engaged as the program progresses. It was a great opportunity to gain new knowledge and I would recommend it to anyone interested in the field of clinical trials.

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Suchi

I found the VIARES Clinical Research Academy course very informative, well explained and interesting. I come from a completely non-Clinical Research background and found this course quite easy to follow. The content is very apt and to the point. I have

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a strong belief that with this course, I have developed a strong foundation into concepts around Clinical Research, which will pave a long way for my career into the future.

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I really enjoyed the VIARES clinical talent program. I’ve learned a lot about the design, regulation and management of clinical trials. This course offers a nice balance between recorded lectures, live webinars and homework that allows youto deepen your understanding and apply some of the concepts taught.

I am very grateful for the opportunity to participate in the VIARES Clinical Research Talent program. The program is well developed and structured. Courses, knowledge checks, assignments and webinars are very useful for understandingthe whole clinical trial process. I have learned a lot of new things. I will definitely use it in my career. I recommend it to anyone who is interested in the field of clinical trials.

Clinical Research Project Specialist

VIARES Academy’s flexibility and content lay out are unique for a clinical research program. With practical examples, detailed follow up webinar, it creates reinforcement of modules allowing candidates to strengthen concepts and find real lifesolutions. I learnt so much on drug development, clinical operations & regulatory affairs even after being in academic research for six years and now look forward to build on more industry related skills. Thank you to all the tutors and administration.

reviews curated by judge.me

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.

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.

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.

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

-50%

BESTSELLER

Clinical Research Project Specialist

Typical annual market salary:
$50,000 and above

$ 16.90 / month for 12 months

$ 99.90Life-Time

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COURSE Content

VIARES CERTIFICATE

Delivered by industry experts

Gabi Disselhoff

GAVIN CHAIT

KAMILA NOVAK

Hear from our graduates

Michela

Suchi

Customer Reviews

WHY BECOME A Clinical Project SPECIALIST?

WHAT ARE TYPICAL RESPONSIBILITIES OF A Clinical Project SPECIALIST?

IS THIS THE BEST OPTION FOR ME?

NEW JOBS POSTED TODAY

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Clinical Research Project Specialist

COURSE Content

VIARES CERTIFICATE

Delivered by industry experts

Gabi Disselhoff

GAVIN CHAIT

KAMILA NOVAK

Hear from our graduates

Michela

Suchi

Customer Reviews

WHY BECOME A Clinical Project SPECIALIST?

WHAT ARE TYPICAL RESPONSIBILITIES OF A Clinical Project SPECIALIST?

IS THIS THE BEST OPTION FOR ME?

NEW JOBS POSTED TODAY

Description

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