The pathway
How you actually get there, here
How you become one varies far more by country than what one does. This is the UK route. Most people take one of these ways in; the right one depends on where you're starting from.
- 1
Regional Research Coordinator (L2)
2-3 yearsSkills to master
- Independent site management (5-10 sites), proficient SDV and query resolution, strong GCP application, effective site communication, basic risk identification.
You're ready to move on when
- Consistently meeting site performance metrics for moderate complexity studies.
- Proactively identifying and resolving routine site issues without constant supervision.
- Receiving positive feedback from sites and internal stakeholders on reliability and responsiveness.
- Successfully completing all required training modules for new protocols and systems.
- 2
Clinical Research Associate (CRA)
3-5 yearsSkills to master
- On-site monitoring, in-depth source document review, comprehensive site visit report writing, strong understanding of clinical trial conduct from a monitoring perspective.
You're ready to move on when
- Demonstrated ability to identify and document significant protocol deviations during site visits.
- Excellent communication and negotiation skills with site staff during monitoring visits.
- Proficiency in using CTMS and EDC systems for monitoring activities.
- Strong organisational skills for managing travel, visit schedules, and follow-up actions.
- 3
Study Start-up Specialist
3-4 yearsSkills to master
- Deep expertise in regulatory submissions, ethics committee processes, site contract negotiation, and essential document collection for rapid site activation.
You're ready to move on when
- Proven track record of activating sites efficiently and on time.
- Expert knowledge of country-specific regulatory requirements for clinical trials.
- Strong negotiation skills for site contracts and budgets.
- Excellent attention to detail in preparing and reviewing submission documents.