Sarah Casalinova

· Direct management of the Cardiothoracic and Ventricular Assist Device research portfolios in the Surgical Office of Clinical Research (SoCR)

· Responsible to the Research Practice Manager (RPM) for oversight of study conduct for research studies within assigned divisions.

· Assist RPM in the day to day management of CRU operations and people.

· Assist in providing operational and study conduct metrics/reports to RPM

· Assist with staff effort distribution, for the assigned divisions, to ensure that staff are appropriately assigned studies based on volume and individual staff competency.

· Conduct annual performance evaluations and performance improvement plans with staff

· Serve as an expert resource to assigned division with regard to study conduct and is knowledgeable about other resources at Duke.

· Supervise and provide guidance on research operations for the studies within the assigned divisions. This includes: regulatory and institutional policies and processes, screening, recruitment and retention, study monitoring, audit visits, participant and study level documentation, study visits, SOPs, specimen management, IND/IDE documentation, investigational product, and contracts and agreements.

· Work with financial staff in developing and negotiating budgets with sponsors.

· Serve as an expert resource to clinical research professionals and outside agencies with regard to study specific protocol requirements and problem solving related to clinical, logistical, financial and regulatory concerns.

· Uses advanced subject matter expertise in clinical research activities to solve complex problems across assigned divisions.

· Report directly to Ian Jamieson, VP of Duke Transplant Center

· Transitioned management of the TransMedics Heart usage from clinical trial to the commercial space. Completed transition September 2021.

· Brought commercial use of the TransMedics Liver device from the ground up (no previous clinical trial use at Duke) in the Spring of 2022.

· Transitioned use of OrganOx Metra device to Duke from clinical trial usage to commercial usage in the Fall of 2022 after FDA approval was received.

· Manage commercial use of all transplant devices used at Duke. Currently this includes: TransMedics OCS Heart, Liver and Lung, OrganOx Metra, Paragonix SherpaPak, Paragonix LUNGguard, and Paragonix LIVERguard.

Includes but not limited to:

§ Supply usage tracking and PO initiation

§ Initial PO/SAP creation

§ Storage management

§ Keep record of usage including recipient, donor information and device lot numbers

§ Build and modify when needed Maestro Care order sets associated with device medications

§ Maintain and coordinate training of staff using these perfusion devices

§ Maintain relationships with the companies and local reps

§ Facilitate bi-annual device maintenance or as needed repairs

§ Available to surgical staff as needed to help trouble shoot. This includes off normal working hours.

· Strategize device volume for next fiscal year projections

· Involved in contract discussions with device companies

· Working with the pediatric cardiac transplant surgeons to start-up a pediatric DCD ta-NRP heart program. This included supply ordering, logistical discussions and OPO education. Currently fielding calls from OPOs across the country with potential pediatric ta-NRP heart cases. What we believe is the first neonatal ta-NRP heart case in the United States was successfully performed at Duke in 2022

· Led the logistical efforts and OPO education with Dr. Joseph Turek for the first two Partial Heart transplantations in the world in 2022. Involved in discussions with UNOS Medical Director new policy implementation surrounding this innovative approach to fixing congenital heart abnormalities such as truncus arteriosus.

· Responsible to the designated SOCR Assistant Research Practice Manager for the day-to-day operations of the Cardiothoracic research team. Ensure that designated research staff are performing assigned study activities in accordance with Good Clinical Practice (GCP), Duke policy and regulatory requirements using standard operating procedures (SOP), routine monitoring and 1:1 meetings with staff.

· oversight of designated staff and delegation of study- or project related tasks

· designating staff study/workload assignments and ensuring staff are appropriately trained

· oversight of study conduct including new study feasibility assessment, study start-up, and progress of ongoing studies

· oversight of regulatory activities, including IRB submissions, safety reporting, continuing renewal, and study close-out

· Supervise the day-to-day operations of the cardiothoracic team related to study conduct, including patient

recruitment, screening, consent, enrollment, and follow-up; development of and compliance with an on-call calendar, data collection and EDC entry; drug/device accountability, study audit/monitoring, subject study records maintenance (electronic and written), and record retention.

· Supervise designated study coordinators and advise ARPM regarding various personnel actions, including:

screen, interview, and hire and train new staff, performance planning and evaluation, scheduling and work assignments, promotions, and disciplinary action.

· Independently facilitate study-start-up

· Provide OR training to new staff across all of SOCR.

· In addition to Team Lead responsibilities, maintains the Heart Transplant Portfolio as Primary Study Coordinator to Dr. Jacob Schroder. The Duke Heart Transplant Research Portfolio has been leading enroller in multiple trials since my involvement as primary coordinator. Cultivated relationships with teams both internal and external to Duke to build the foundation for successful enrollment and implementation of the Duke Transmedics program. This led to the first adult DCD heart transplant in the United States to be performed at Duke in December of 2019 and the first pediatric DCD heart transplant with the OCS Heart device in 2021.

· Invited to participate in database development by TransMedics for their most recent two heart transplant clinical

trials.

· Frequently asked to provide mentorship to other coordinators across the country via study Sponsors.

· Train new CRCs on consenting and proctor mock consent training.

· Trained to set-up, assist, and monitor the TransMedics Heart device and organ alongside procurement surgeons during TransMedics heart procurements.

· Assisted on 81 TransMedics heart procurements. A mix of both DBD and DCD. On call for these cases a minimum of 14 days per month.

· Field train perfusionists after their formal TransMedics training by the company. Accompany them on their first

few cases. Teach them the flow of donor ORs and monitor their use of the device their first few cases.

· Create and update workflows as needed for the procurement team, research team and clinical heart coordinators for working up a TransMedics case.

· Research liaison between Duke and local OPO. Update local OPO on status of our program monthly. Work with local OPO staff on creating TransMedics educational material for outside Organ Procurement Organizations.

· Sought after by Organ Procurement Organizations and large medical centers across the country to discuss how to implement TransMedics at their local centers. Field frequent phone calls and emails consulting on the DCD heart donor OR experience, management and set-up.