Study Coordination and Regulatory Services

Our Clinic Coordinator, Catherine Bunce, has twelve years of experience in managing NIH-funded and sponsor-funded research studies.  As the Clinic Coordinator, she has a history of managing, operationalizing, and conducting 6-7 studies simultaneously - with yearly average enrollment of 100/year.

To discuss how we can help you with study coordination and regulatory services, please contact our Clinic Coordinator:
Catherine Bunce
(585) 275-5744

Regulatory

• Assistance in writing the protocol and/or the consent form
• Completion and submission of the protocol into the ROSS System of the UR Research Subject Review Board or WIRB
• Development of Standard Operating Procedures

Coordination and Operational Support

• Consultation services on operationalizing a study
• Assessment  of staffing needs
• Budgetary projection
• Development and implementation of case report forms
• Training of staff or facilitating the resources for specific training of staff
• Documentation of training to meet GCP, NIH, and study sponsor requirements
• Maintaining regulatory files per CFR and GCP standards
• Develop, implement and evaluate a Quality Management Plan

Budgetary Oversight

• Assistance with or creation of budget with projection of costs
• Ongoing oversight of ledgers, tracking expenditures, and forecasting deficits or overage.