John Carlins Email & Phone Number

Pittsburgh, PA, US

Seoul, Korea, KR

• Responsible for supporting Chief Medical Officer in developing a proactive enrollment plan at clinical trial sites and their referral centers to enable rapid and timely subject enrollment at the target rate along with.
• Supported enrollment and recruitment activities
• Reviewed all screening documents to assure that all subjects were eligible prior to randomizing
• Managed the randomization schedule to assure that all subjects were assigned to the correct treatment regimen
• Provided technical expertise to support the ELAD team (nurses trained to run the device at the clinical sites) as well as the principal investigators, other ICU physicians and nurses as well as other research staff
• Assisted Medical Monitor with pharmacovigilance

Responsible for supporting Chief Medical Officer with clinical content, technical expertise, training, patient management, representing the company at external events, and contributing to the overall success of multiple clinical trialsAssisted executive management with medical aspects of clinical studyKey role in clinical trial protocol development.

• VTI developed the first human liver cell based biologic liver support system, ELAD®
• Managed daily operations, conducted assessments and performance evaluations at 32 clinical sites in the US, UK, EU, Singapore, Saudi Arabia and China during Phase II/III clinical trials involving ELAD® in subjects with.
• Collaborated with senior management to establish and mobilize the ELAD® trial design, including formulating the study, drafting/evaluating protocol, investigating outcomes, ensuring regulatory compliance and assisting.
• Drafted ELAD® Standard Operating Procedures and Operator’s Manual in collaboration with chief scientist and engineering department
• Developed training and certification program for ELAD® Specialists; trained and managed clinical team, both domestic and international, including directly supervising 9 ELAD® Specialists, 4 CRA’s and controlling.
• Oversaw 19 US, 7 UK, 1 Denmark, 1 Saudi, 2 Singapore and 2 China investigational clinical study sites, which included direct responsibility for regulatory compliance, pre-study site assessments, Western IRB protocol.

• Drafted guidelines for human investigational clinical trial work in the area of acute liver failure
• Assisted with design, development/testing and operation of ELAD® System; drafted Operators Manual with chief scientist and engineer
• Acted as Senior ELAD® Specialist at 2 Beijing, China hospitals during Phase III trial; diagnosed and solved technical issues related to operation of ELAD® System
• Trained and supervised Chinese clinical site nursing staff ELAD® Specialists; educated Chinese Principal Investigators and medical staff; facilitated successful communication between company and Principal Investigators.
• Achieved statistical significance in transplant free survival for treated subjects and assisted in organizing data for marketing application to the Chinese SFDA

• Coordinated industry and grant sponsored research for Department of Critical Care Medicine
• Assisted in directing studies, quantifying and compiling data and ensuring regulatory compliance
• Documented study requirements and fulfilled both internal and external regulations in accordance with various protocol guidelines

• Liver Transplant Intensive Care Unit and Cardiothoracic Intensive Care Unit
• Staffed unit dedicated to helping some of the most medically compromised patients from around the world with end-stage organ failure
• Operated as active multidisciplinary team member working towards continual improvement of the clinical, scientific and social aspects of transplantation to improve the lives of patients and families

Bs, Nursing

Bsn, Registered Nursing/Registered Nurse