Module 14 · Part 4 · Participants
Working with Study Coordinators
Understand the role of study coordinators in multisite registries and how to build effective relationships with clinical sites.
Patient Registries 101 · Dr. Danielle Boyce · EpilepsyLive
What study coordinators do
- Study coordinators (also called research coordinators or clinical research coordinators) are the backbone of clinical site participation in registries.
- Identify and approach eligible participants at their site
- Obtain informed consent
- Complete or verify clinical data entry
- Collect and process biosamples (if applicable)
- Manage site regulatory documentation (IRB approvals, delegation logs)
What study coordinators do (cont.)
- Communicate with your registry team about site level issues
- For a rare disease registry, your relationship with study coordinators at key clinical centers is as important as your relationship with the physicians.
Site agreements
- Each participating clinical site needs
- Site agreement / participating site agreement (PSA): Defines the site's responsibilities, your organization's responsibilities, compensation, and data handling
- IRB authorization: Either reliance on your central IRB or local IRB approval
- HIPAA BAA: If the site is sending identifiable data
Coordinator training
- Build a training program for new coordinators
- Registry overview and scientific purpose
- Eligibility criteria and how to identify participants
- Consent process and documentation
- Data entry procedures (platform walkthrough)
- Sample collection and shipping (if applicable)
Coordinator training (cont.)
- Regulatory requirements
- Provide: training slides, written SOPs, a quick reference guide, and a direct contact for questions.
Coordinator compensation
- Study coordinators' time should be compensated.
- Per-participant payment: A set amount for each enrolled and verified participant ($100, $500 depending on data complexity)
- Site grant: Annual site support payment covering coordinator time
Keeping coordinators engaged
- Sites with an enthusiastic coordinator enroll dramatically more participants than sites with a disengaged one.
- Personal outreach (email, phone calls), not just automated system messages
- Coordinator-specific newsletter with recruitment tips and registry updates
- Recognition of high-enrolling sites
- Regular coordinator calls (quarterly) to share learnings and address problems
- Site visit support (virtual or in-person) for sites that are struggling
Key resources
- ACRP: Association of Clinical Research Professionals
- SOCRA: Society of Clinical Research Associates
- ACRP Coordinator Training Resources
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