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.

More Information

For more information, or to make an appointment, please contact us at
(585) 275-0526.

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