Judith Douville Email & Phone Number

Indianapolis, Indiana (Working Remotely)

-Participating on YourEncore expert team conducting blind data review of Phase III clinical trial data from drug study sponsored by Pfizer, Inc., Inotuzumab.-Participated on 3 YourEncore expert teams conducting blind data reviews of Phase III clinical trial data from 3 drug studies sponsored by Pfizer, Inc., Apixaban, Dacomitinib and Tofacitinib.

Tecumseh, Michigan

Contract Tissue Bank Coordinator for Vericel Corporation (formerly Aastrom Biosciences) AUG 2013 to Present-Coordinate and conduct Tissue Bank Medical Advisory Committee Annual Meeting.-For the two Vericel tissue bank facilities in Ann Arbor, MI and Cambridge, MA, manage annual renewal applications for tissue bank licenses required by 4 U.S. States, along with annual renewal of tissue bank registration with the FDA.Contract Bone Marrow Aspiration Training Specialist for Vericel Corporation APR 2013 to DEC 2014-For Phase IIB clinical trial, trained clinical study personnel on the methods and techniques required for aspirating highly cellular bone marrow samples for production of patient-specific bone marrow-derived expanded multicellular therapy.

Ann Arbor, Michigan

-Participated in operational execution of activities associated with Phase III clinical trial for critical limb ischemia.-Prepared SOPs, developed process and training materials for key clinical procedure of Phase III clinical trial. Selected and trained 6 research RN's to train clinical site personnel on key clinical procedure. Negotiated service agreement and compensation schedule with vendor. Managed and monitored RN training activities at clinical sites.-Assisted with study start-up activities of new Phase IIb clinical trial for treatment of ischemic dilated cardiomypathy.-Managed clinical site budget development ($40,000/study subject) and investigator contract reviews.-Project Manager for cross-functional team managing all aspects of 2 multi-center Phase II clinical trials treating dilated cardiomyopathy.-Functioned as Tissue Bank Coordinator responsible for determining if Aastrom and clinical sites require State tissue bank license in order to conduct a clinical trial in the State of clinical trial site. -Responsible for the initial application, renewal, post/filing and maintenance of State tissue bank licenses.

Ann Arbor, Michigan

-Participated in design discussions, protocol review and tactical planning of clinical trials for treatment of cardiac disease using autologous bone marrow-derived expanded mononuclear cells.-Recruited 5 investigators for participation in 2 multi-center Phase II clinical trials treating dilated cardiomyopathy.-Managed clinical site budget development ($35,000/stuidy subject and $55,000/study subject) and investigator contract reviews.-Conducted clinical trial initiation meetings and monitored rate of patient enrollment into clinical trials.-Coordinated materials for DSMB quarterly data reviews.

Ann Arbor, Michigan

-Participated in design discussions, protocol review and tactical planning of clinical trials for treatment of bone and peripheral arterial diseases using autologous bone marrow-derived expanded mononuclear cells.-Recruited 6 investigators for participation in multi-center Phase II clinical trial treating osteonecrosis.-Recruited 23 investigators for participation in multi-center Phase II clinical trial treating crticial limb ischemia.-Managed clinical site budget development ($20,000/study subject) and investigator contract reviews.-Planned an Investigator Meeting.-Conducted clinical trial initiation meetings at 22 clinical sites and monitored rate of patient enrollment into clinical trials.

Ann Arbor, Michigan

-Designed an effective AastromReplicell System user training program for clinical and customer settings.-Wrote the AastromReplicell System User Manual for bone marrow stem cell and dendritic cell applications.-Coordinated clinical and customer activities related to operation of the AastromReplicell System in the U.S. and Europe.

Ann Arbor, Michigan

-Performed pre-clinical experiments at Aastrom research laboratory to validate operation of the Aastrom Replicell System prototypes.-Developed AastromReplicell System prototype operations and cell processing SOP's.-Coordinated, implemented and managed clinical trial activities related to operation of the AastromReplicell System prototype at clinical trial sites in the U.S. and Europe.

Ann Arbor, Michigan

-Organized Bone Marrow Processing Laboratory activities, coordinated workflow, and established work priorities.- Supervised 3 laboratory staff members.-Developed, modified, maintained and implemented procedures for bone marrow and peripheral blood stem cell collection, processing, storage and quality assurance.-Established and maintained laboratory compliance with new policies, procedures and record keeping necessary to meet the standards of accrediting and regulatory agencies.

Ann Arbor, Michigan

-Managed the scheduling of blood donations, outpatient transfusions and therapeutic apheresis.-Supervised and assigned work activities to 5 unit staff members.-Developed, modified, maintained and implemented procedures for phlebotomy, outpatient transfusion and automated apheresis.-Established and maintained laboratory compliance with new policies, procedures and record keeping necessary to meet the standards of accrediting and regulatory agencies.

Ann Arbor, Michigan

-Resolved antibody problems found in positive antibody screens and crosmatches.-Determined safe transfusion practices for patients with red cell antibody problems and ABO/Rh problems.-Served as a resource person to Blood Bank bench technologists in the performance of tests and procedures.

Master Of Arts (M.A.), Management And Supervision

Internship, Clinical Laboratory Science/Medical Technology/Technologist

Bachelor Of Science (B.S.), Clinical Laboratory Science/Medical Technology/Technologist