Coordination Services Include:
General and Pre-Study Services
- Coordination of funded research; federal, industry or department funded research
- Pre-study start up activities; preparation, collection and completion of requested forms.
- Complete site verification forms, 1572, CDA, liaison with JROC for contract negotiations
- Participate in conference calls and study meetings as needed
- Site initiation visits; in-house as well as attendance at investigator training sessions
- Expertise in common imaging modalities; CT, MRI, X-ray, mammography and sonography.
- Services available for experimental technologies, device interventions, and diagnostic tools.
- Budget preparation and negotiation with sponsors. Work closely with PI, ORSR, or CCS as needed.
- Protocol review/edit as needed.
- Case Report Form (CRF) design.
- Identify needed collaborators.
- Arrange and schedule pre-study visits.
Regulatory Services Include:
- IRB (HRPO) - new submissions, renewals, amendments, study closures.
- Inform Consent review and editing.
- PRMC and RDRC assistance.
- FDA (IND/IDE) Support
- Contact Patricia Rueweler for your specific needs, firstname.lastname@example.org
- Eligibility screening, recruiting, enrolling/consenting and long-term follow-up.
- Coordination of study visits, procedures and compliance checks.
- Large study recruitment efforts utilizing advertising and multimedia resources.
- Tracking and monitoring of study participant; follow-up visits, reminder notifications, additional triggers for subjects lost to follow-up, survey/questionnaire, etc.