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and kickstart your career 🎓

Clinical Operations Specialist

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, …

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!

Certificate:

  • VIARES, GCP and ACRP ELKA
 

The fee includes:

  • registration fee
  • all online-training course material
  • one year online access to our learning management system
  • mini-exams during the training to test your knowledge
  • VIARES exam of 100 question
  • personalized certificate upon completion
 

plus exclusive VIARES benefits:

  • get automatically accepted as Ambassadors and earn credits
  • 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
  • addition 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) test. Upon successful completion, you will receive ACRP’s endorsement (ELKA certificate) of their foundational competencies required for entry-level roles in clinical research

Course Content

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

10 Modules – 100 Learning Hours – 3 Certificates.

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.

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.

Hear from our graduates

Jessica

Jessica

Thank you to Dietmar Eglhofer, all the instructors and VIARES Academy for this excellent, dynamic, interesting, organized, and accessible program that contribute enormously to my knowledge and development of the skills in Clinical Research activities.

Jackson

Jackson

The VIARES CRA Talent Program was an opportunity for me to achieve rich and tailored knowledge on Clinical Trials. It offered an opportunity for me to learn considering a career switch from the Investigator operations to monitoring. Being guided

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by professionals with extensive first-hand experience made the intensive program easily manageable.

I strongly recommend the VIARES Talent Program and will spread the word to acquaintances.

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Clinical Operations Specialist
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£ 139.00

£ 15.00 / month for 12 monthsPay monthly

    SOMMER SPECIAL - GET 50% OFF THE 2nd COURSE
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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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