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Clinical Operations Specialist

Content: Medicines Development Process, Good Clinical Practice, Regulatory Environment in the EU and USA, Clinical Trial Design,Patient Protection & Adverse Events, Study Start Up Basics, Project Managment,…

Learning: 80-100 hours online and self-paced, 10 Modules, Final Exam

Certificates: GCP, VIARES, ACRP

Prerequisites: ideally life science education – no work experience required

pay in 12 monthly installments or save with our optional 1-time payment

The Clinical Operations Specialist

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

More than a Course

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.

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!

The Training includes access to all Academy Services, and an industry recognized Professional Certification.

  • modules including
    • e-learnings
    • assignments
    • knowledge checks
  • VIARES ACADEMY certificate
  • GCP certification
  • ACRP Entry Level Knowledge Assessment certificate (ELKA)
  • One year free ACRP membership
  • Set clear goals
  • Get properly trained
  • CV, CV, CV
  • Ace Your Interview
  • Negotiate
  • Weekly new Global Jobs
  • Skip the Application Line
  • Join Career Events

Course Program

The Clinical Operations Specialist training course consists of ten consecutive modules. You will complete each module by:

  • taking your e-learning
  • submitting your assignment work
  • reviewing pre-recorded webinars
  • completing your module test
  • taking the final exam

10 Modules – 100 Learning Hours – 3 Certificates.

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

In addition to VIARES lifetime membership, you will get a 1-year free membership with ACRP. You will also be able to take ACRP’s new ELKA (Entry-Level Knowledge Assessment) testUpon successful completion, you will receive ACRP’s endorsement (ELKA certificate) of their foundational competencies required for entry-level roles in clinical research.

  • 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.
"I profit from participating in the VIARES CRA Academy, where the team personally takes cares for the students. The program is well structured to learn from experienced tutors and aligns with my work schedule. The learning management system provides access to the learning information any time."
Dmytro K VIARES Graduate

Start today

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.

Your expert instructors

Eric Klaver VIARES Clinical Research Associate Training Expert Instructor
Eric Klaver
Gabriele Disselhoff VIARES Clinical Research Associate Training Expert Instructor
Gabriele Disselhoff
Kamila Novak
Bartek Jarosz

Who should attend the Course

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 and we will contact you.

Course fees

The fee includes:

  • registration fee
  • all online-training course material, 100% online available in our learning management system
  • module check points (mini-exams during the training to test your knowledge)
  • end-term exam
  • VIARES and GCP certificates upon successful completion of the end-term exam
  • ELKA test and exam from ACRP (Association of Clinical Research Professionals)
  • one year free membership with ACRP

plus exlusive VIARES benefits:

  • get automatically accepted as Ambassadors and earn cash
  • 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

Jobs matching this Course

This is a snapshot of 10 latest new entries from our full list of 6,313 Global Clinical Research jobs. Our list is updated and curated for you daily, adding hundreds of new jobs.

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Request Course outline

Get a PDF of all training details to view more details about each module and view testimonials from past participants:

Other Clinical Research Courses

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Dmytro K
VIARES Graduate
"I profit from participating in the VIARES CRA Academy, where the team personally takes cares for the students. The program is well structured to learn from experienced tutors and aligns with my work schedule. The learning management system provides access to the learning information any time."