If you are keen on joining the ClinOps training program, please share your interest by filling out the contact form, and we will reach out when the application process officially opens.

This course is open to those who:

• Currently work in clinical research as a Study Coordinator (SC) or wish to work in this field.

• Have experience working as a study coordinator, investigator, co-investigator, study manager/assistant, or research nurse

• Have an academic qualification in one of the following fields: nursing, medicine, pharmacy, biomedical sciences, statistics, or a related subject.

• Are an applicant with relevant experience or motivation without formal academic qualifications (applicants from sites with minimal clinical trial capacity, in terms of experience/ training, will be given priority)

We are actively seeking partnerships to strengthen the clinical trial ecosystem in Africa. If you’re interested in sponsoring applicants, or exploring collaboration opportunities, please contact us at info.clinops@cdt-africa.edu.et for further details on next steps.

The next course will run for 10 weeks starting from 26 May 2025.

We will announce on this website whenever we plan to deliver the course.

The cost of the course for the whole 10 modules, including synchro-nous and asynchronous tutorials, group work, forum discussions, and certification, is $2,000 USD per participant; applicants offered a spot for the course will have access to funding support based on their need.

The ClinOps course consists of 10 consecutive lessons delivered via interactive recorded presentations, live and asynchronous tutorials, discussion forums, and personalized mentoring.

1. Introduction to Clinical Trial Operations

2. Data Management and Biostatistics

3. Study Design and Protocol Development

4. Project, Financial, and Risk Management

5. Conducting a Trial 1

6. Conducting a Trial 2

7. Closing out and Reporting a Trial

8. Working with External Partners

9. Quality Systems, Audits & Inspections

10. Pharmacovigilance

The ClinOps course aims to instill these skills in participants who successfully complete the course:

• Trial Start-Up: Preparing research sites for clinical trial start-up through an overall understanding of the clinical trial process, from project management to trial design and protocol development.

• GCP Compliance: Demonstrating the ability to conduct GCP-compliant clinical trials in conformance with ethical principles. This includes patient recruitment and retention approaches, data management, monitoring, pharmacovigilance, and safety reporting.

• Quality Systems: Designing and maintaining the quality system of a clinical trial through implementing SOPs, risk management approaches, handling audits and inspections, as well as other aspects of quality control and quality assurance.

• Site Management: Identifying and addressing key challenges in managing the research sites including developing and maintaining capacity, retaining research staff, community engagement, and managing grants.

• People Skills: Developing people management skills and techniques that are useful in working with internal colleagues and external partners

• Trial Closure: Efficiently closing out clinical trials, handling post-trial responsibilities and reporting results in a timely manner

Students must be able to commit 8 to 12 hours to study each week of the course.

The assessment for this course has two main components:

• Group Assignment: You and your group members will collaborate to draft a risk management plan related to the lessons covered in the course.

• Individual Assessment: includes participation in the forum discussions, VoiceThreads, the live tutorials, as well as performance on the quizzes within the lessons.

• *Students will be given three weeks after the course ends to finalize your assessment if not already completed during the course.

Most of the assessment will be completed during the online lessons and you will have three weeks after the course ends to complete and submit the remainder of outstanding assignments

To better understand the proposed course, you may view an open access version of the course for Africa-based Coordinators here:

https://courses.cdt-africa.org/course/view.php?id=19

Log in as a ‘guest’

Sign up to get the latest updates on ClinOps here.