Clinical Operations 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 Operations Specialist or similar.

WE TRAIN AND CERTIFY YOU

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
  • SSU structure, responsibilities and involvement in project life-cycle
  • Main groups of core study submission documents
  • Core documents required for submissions
  • Documents development responsibilities
  • Core submission package
  • Critical path for efficient start up
  • Country level documents for submission
  • Country documents development responsibilities
  • Country adaptations
  • ICFs / Assents requirements, adaptation and GDPR
  • Labels
  • Translation requirements
  • Site level documents
  • Country submission packages
  • IP release package compilation – responsibilities and timelines
  • Documents required for IP release
  • FDA requirements vs. EU regulations
  • IP release checklist
  • FDA filing
  • 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.

The VIARES Certification is an online exam covering 100 questions from the VIARES training course. You need to complete the exam within 90 minutes and achieve at least 80% of all points to be graded positive. You have two attempts, of which the attempt with the higher score is applied for your certification.

After successful completion of the exam, you will be graduating the VIARES program and obtain your certificate.

Requirements

This program will be of benefit to anyone with a life science degree and/or first relevant work experience, ideally in clinical research, pharma or related areas, e.g. working with patients, medical products or services, medical technology, laboratories or similar.

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.

WHY BECOME A Clinical Operations SPECIALIST?

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

  • Contributing to improving healthcare: As a clinical operations specialist, you will play an important role in managing clinical trials and ensuring that they are conducted safely, efficiently, and ethically. By doing so, you will be contributing to the development of new treatments and therapies that can ultimately improve the health and well-being of patients.
  • Career growth opportunities: Clinical operations is a growing field, and there is a high demand for professionals with expertise in this area. By becoming a clinical operations specialist, you can expect to have a wide range of career growth opportunities, including the potential to move into leadership roles.
  • Competitive compensation: Due to the demand for clinical operations specialists, many employers offer competitive compensation packages, including salaries, benefits, and opportunities for bonuses and other incentives. The salary of a clinical operations specialist can vary depending on a variety of factors, such as level of education and experience, location, and the specific industry or organization that employs them. According to the job search website Glassdoor, the average base salary for a clinical operations specialist in the United States is around $79,000 per year, with a range of approximately $54,000 to $119,000 per year. However, salaries can be higher in certain industries, such as biotechnology or pharmaceuticals, where the demand for clinical operations specialists is particularly high.
  • Variety of work: Clinical operations specialists work on a variety of tasks, including project management, study design, data management, and regulatory compliance. This variety of work can help keep your job interesting and challenging.
  • Flexibility: Clinical operations specialists may work in a variety of settings, including academic research institutions, government agencies, and private industry. This flexibility can allow you to find a work environment that best suits your interests and goals.

WHAT ARE TYPICAL RESPONSIBILITIES OF A Clinical Operations SPECIALIST?

The responsibilities of a clinical operations specialist can vary depending on the specific organization or industry in which they work. However, some common responsibilities of a clinical operations specialist may include:

  • Designing and implementing clinical trials: Clinical operations specialists may be involved in designing and implementing clinical trials that are safe, efficient, and ethically sound.
  • Managing study timelines and budgets: Clinical operations specialists may be involved in creating and managing study timelines and budgets to ensure that trials are completed on time and within budget.
  • Monitoring study progress: Clinical operations specialists may monitor study progress to ensure that trials are being conducted according to protocol, regulatory requirements, and industry standards.
  • Coordinating with cross-functional teams: Clinical operations specialists may work closely with cross-functional teams, including data management, biostatistics, medical writing, and clinical sites to ensure the smooth execution of clinical trials.
  • Ensuring regulatory compliance: Clinical operations specialists may be involved in ensuring clinical trials are compliant with relevant regulatory requirements, such as those set forth by the FDA or other regulatory agencies.
  • Conducting risk assessments: Clinical operations specialists may be involved in assessing and managing risks associated with clinical trials to ensure patient safety and regulatory compliance.
  • Maintaining study documentation: Clinical operations specialists may be responsible for maintaining study documentation, including study protocols, informed consent forms, and study reports.
  • Overseeing site selection and management: Clinical operations specialists may be involved in the selection and management of clinical trial sites, including identifying and qualifying potential sites, and ensuring that they have the necessary resources and support to conduct the trial.

 

Overall, clinical operations specialists play a critical role in the successful execution of clinical trials, helping to ensure that new treatments and therapies can be developed and brought to market in a safe and efficient manner.

IS THIS THE BEST OPTION FOR ME?

To become a clinical operations specialist, you will typically need to have a strong educational background in a relevant field and relevant work experience. Here are some common educational and professional backgrounds that can prepare you for a career as a clinical operations specialist:

  • Bachelor’s degree in a relevant field: A bachelor’s degree in a relevant field, such as life sciences, nursing, or healthcare management, can provide a good foundation for a career in clinical operations. Relevant coursework may include clinical trial design, regulatory compliance, and clinical data management.
  • Work experience in clinical research: Clinical operations specialists typically have first experience working in clinical research, either in a research site, pharmaceutical company or in a CRO (Contract Research Organization). Experience in project management, study coordination, or data management are particularly relevant.
  • Certifications: Some clinical operations specialists may choose to pursue professional certifications in relevant areas such as clinical research, clinical operations, and project management. 

 

Overall, a combination of education, work experience, and professional certifications can help prepare you for a successful career as a clinical operations specialist.

WHY GET A CERTIFICATION?

Obtaining a clinical operations specialist certificate can provide a number of benefits to individuals seeking to enhance their career in clinical research. Here are some reasons why you might consider getting a clinical operations specialist certificate:

  • Enhance your knowledge and skills: Clinical operations specialist certificate programs provide specialized training and education in key areas of clinical research, including study design, protocol development, data management, and regulatory compliance. By completing a certificate program, you can enhance your knowledge and skills in these areas and improve your ability to perform your job.
  • Increase your marketability: Employers in the clinical research field often look for candidates with specialized skills and knowledge, and having a clinical operations specialist certificate can make you a more attractive job candidate. By demonstrating your expertise in clinical research through a certificate program, you may be able to increase your chances of getting hired and advance in your career.
  • Demonstrates professional commitment: Obtaining a clinical operations specialist certificate demonstrates your commitment to your profession and your desire to improve your skills and knowledge. This can help you stand out as a dedicated and motivated professional in your field.

Overall, obtaining a clinical operations specialist certificate can provide a number of benefits to individuals seeking to enhance their career in clinical research, including improved knowledge and skills, increased marketability, networking opportunities, regulatory compliance, and professional recognition.

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.

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Description

A top entry level job in a growing industry

The Clinical Operations Specialist contributes to the clinical research team by planning, managing, and executing clinical studies. Responsibilities include performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Good Clinical Practice and ICH Guidelines.

The Clinical Operations Specialist assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites, communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines. The role furthermore can be responsible to create and maintain Trial Master File (TMF) and study documents. It supports the study start up activities in preparing and maintaining essential documents.

This role interfaces with study stakeholders across several functions: including Regulatory, R&D, Clinical Project Management, Clinical Scientists and Biostatistics and need to develop working relationships with investigators, ethics committees, other external research staff, hospital staff and vendors

A Flexible Online Setup

Our setup enables you to complete this program either next to a full-time job or in a focused effort. 100% of the program is online and most of the training courses can be completed at any time.
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 Operations Specialist, In-House Clinical Research Associate or similar.

The VIARES Clinical Operations 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 of 100 question – 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

Hear from our graduates

Marta

Marta

I am an MD and currently a Ph.D. candidate in Molecular biology. I enrolled in the July 2020 Talent Program, and I am very satisfied with received knowledge and the amount of practical activity. I am very proud to announce that I have successfully

[expand]

passed the Final Exam on the VIARES Clinical Research Talent Program with a 98.34% result. I reckon that the VIARES program will help in my future career. Thank you to the VIARES team.

[/expand]

Nassim

Nassim

Many thanks to the supportive team at VIARES academy for providing a well-organized and thorough training. The course content was very informative, comprehensive and very well presented. It was a wonderful experience and made me

[expand]

feel more confident to pursue a career in Clinical Research.

[/expand]

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Clinical Operations Specialist
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      ERIC KLAVER

      Trained in 6 continents

      Eric brings with him 20 years of experience training and meeting management and has worked in clinical research for almost 25 years. The global reach of this experience (Eric has trained in six continents) makes him the partner of choice to work with. Eric combines soft skills with personal responsibility in every training.

      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.

      BARTEK JAROSZ

      18 Years experience

      Bartek has 18 years experience in clinical research business, mostly spent at largest global Contract Research Organizations. At Quintiles he was responsible for pioneer development of clinical start-up and regional contract departments. He served as executive member of clinical start-up leadership team at INC Research, acting as global head of site contract division. His most recent experience includes support for pharmaceutical organizations in various project specific roles. Bartek enables biopharma to get their sites up and running faster. He is author of several training programs about site contract related matters and successfully delivered to hundreds of individuals worldwide.

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