What study coordinators do
Study coordinators (also called research coordinators or clinical research coordinators) are the backbone of clinical site participation in registries. They:
- 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)
- 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.
Setting up clinical sites
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)
- 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. Typical models:
- 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. Invest in coordinator relationships:
- 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