The St. Luke’s University Health Network Clinical Trials Office (CTO) is the clinical and administrative shared resource for the conduct and management of sponsored clinical research across SLUHN under the direction Tracy Butryn, MS, CCRP, CHRC. The SLUHN Clinical Trials Office allows a centralized and streamlined approach to all sponsored-research conducted throughout our University Health Network by integrating both the clinical operational team and the research administration team into one centralized office. This infrastructure ensures that both the clinical and administrative operations involved in clinical research are compliant with all regulations and policies, and that the workflow between sponsors, physicians, clinical support staff, and other ancillary departments is streamlined and efficient. Our team is comprised of expert and dedicated clinicians and staff, with experience in the conduct of clinical trials and research in both the outpatient and inpatient setting, as well as across a multitude of therapeutic areas.
The basic functions of the SLUHN Clinical Trials Office are to:
- Serve as the official point of contact for the various sponsors of scientific and scholarly activity.
- Facilitate the relationship between SLUHN investigators and sponsors in the protocol review process, start-up process and activation, and study conduct through completion of the study closeout.
- Ensure sponsored projects are managed in accordance with local, state, and Federal regulations, as well as SLUHN policies.
- Provide education and resources to support the management of sponsored programs
- Facilitate and negotiate all pre-award activities such as budgets and Clinical Trial Agreements, and manage all post-award activities such as billing compliance and invoicing.
- Coordinate clinical research activities including operational, clinical, regulatory, and financial functions
- Process and maintain records and data on all clinical trial protocols and study participants through the entire trial lifecycle
- Ensure regulatory compliance by establishing quality control measures and processes