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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 Management, and more.
Learning: 80-100 hours online and self-paced, 10 Modules, Final Exam
Certificates: GCP, Get Cognitio, ACRP
Prerequisites: Ideally life science education – no work experience required
Payment: 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.
It’s Not Just A Course
It’s A Self-Paced 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 Get Cognitio 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.
Access to all Academy Services
Modules including:
- e-learnings
- assignments
- knowledge checks
Industry Recognized Professional Certification
- Get Cognitio Certificate
- GCP Certification
ACRP ELKA and Membership
- ACRP Entry Level Knowledge Assessment certificate (ELKA)
- One year free ACRP membership
5 Steps Guide to Get Your Dream Job
- Set clear goals
- Get properly trained
- CV, CV, CV
- Ace Your Interview
- Negotiate
Global Clinical Research Jobs
- 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 Get Cognitio Academy Certificate.
In addition to Get Cognitio 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) test. Upon successful completion, you will receive ACRP’s endorsement (ELKA certificate) of their foundational competencies required for entry-level roles in clinical research.
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
Study Start Up Basics
- 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 and site level submission documents, adaptation and translation
- 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 Document Requirements
- IP release package compilation – responsibilities and timelines
- Documents required for IP release
- FDA requirements vs. EU regulations
- IP release checklist
- FDA filing
Clinical Research 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.
Clinical Research 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.
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.
Our Expert Instructors
Vince W
CRA Instructor
Cynthia L
CRA Instructor
Jessie C
CRA Instructor
Lauren M
CRA Instructor
Who should attend
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 info@getcognitio.com 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
- Get Cognitio and GCP certificates upon successful completion of the end-term exam
plus exclusive Get Cognitio 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
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