•Responsible for the management of 4 sites for the SPYRAL HTN Off-Med/On-Med Renal Denervation Study – RF tipped catheter used by Interventional Cardiologists in the Cath Lab for the ablation of sympathetic nerves adjacent to the renal arteries and their branches for the control of hypertension.•Responsible for the management of 2 sites for the Onyx ONE Clear (Coronary Drug Eluting Stent) Study – DES used by Interventional Cardiologists in the Cath Lab for high risk bleeding patients on dual anti-platelet therapy (DAPT).

Support clinical trials at assigned sites including the responsibility of site management by coordinating all activities pertaining to qualification and initiation of and ongoing site support for the clinical trial. Provide in-service education and training for physicians, hospital personnel and office staff on study related documents and devices in support of Company clinical trials. Provide occasional training and oversight for study monitors as well as attending monitoring visits to provide training/support on device and / or technical expertise on an as needed basis. Perform site activities in compliance with GCP and FDA regulations for clinical trials. Provide technical assistance during clinical study procedures with Company products Partner with the study team and the study sites to drive study enrollments. Document problems related to investigational devices. Submit periodic status reports on all study programs and activities. Review and provide feedback on clinical strategy and protocols.

Product training of surgeons, distributors, collaborators, and internal staff Preparation and performance of occasional animal surgery / animal studies Participation in developing new medical applications for our products Participation in preparation of intellectual property for our products Participation in external collaborations and on R&D projects with colleagues in the US and Japan Participation in scientific and medical conferences and trade shows

Smart PReP - Autologous Platelet Concentrate SystemSmart PreP2 - Bone Marrow Aspiration Concentration System Regulatory Affairs DepartmentClinical Trials Manager Association of Clinical Research Professionals (ACRP)Involved in the initiation, training, and management of multiple study sitesfor three clinical research studies: Wound Care Study - application of platelet rich plasma (PRP) to diabetic, non-healing ulcers. Peripheral Arterial Disease Study - injection of bone marrow aspirate concentrate (BMAC) into critically ischemic limbs. Cardiac Study - post-CABG injection of BMAC into myocardium.

Performed comparative testing of several competitors' devices in the lab to qualify and quantify final platelet yields by parameters set forth by The American Association of Blood Banking (AABB).Also supported several off-site studies (human and animal models) developing the usage of and demonstrating the effectiveness of both PRP and BMAC.

Involved in alpha and beta stages of device pre-launch. Brought clinical feedback from "real world" back to Harvest so that design changes could be implemented prior to hand-off of machine and disposable production from engineering to manufacturing.Collaborated with marketing and manufacturing to recognize the need for modifications to current disposable kits and the development of differentiated kits as well. Helped develop practical clinical protocols for device usage in variety of settings including hospital OR's, surgical centers, wound care centers, podiatry and dental offices. Interpreted published articles on platelet gel therapies from the scientific to an appropriate level for potential account decision-makers (surgeons, nurses, anesthetists, perfusionists, administrators, materials management, etc.).Coordinated nationwide in-servicing/training of clinical users (customers).Implemented Phlebotomy Workshop for clinicians.Set up and ran "hands-on laboratory" demonstrations at various national and regional surgical conferences.Assisted in the training and motivation of 10 Harvest Sales Reps., 40 LifeCell Reps., and over 1,000 Johnson & Johnson Reps. (USA and Canada). Helped Johnson & Johnson create Orthobiologic Sales Rep. position.Worked with leading surgeons from several specialties to develop product usage protocols. Examples include plastics, cardiac, dental, orthopaedic and wound care.

Cardiac SurgeryPer DiemPerfusionist

Cardiac SurgeryPerfusionistCertified Clinical Perfusionist (CCP)The American Board of Cardiovascular Perfusion (ABCP)Operated cardiopulmonary bypass machine during open-heart surgery.Procedure experience includes bypass grafting, valve replacement, heart and/or lung transplant, circulatory arrest for aneurismal repair, veno-veno bypass for liver transplant, rapid infusers for trauma, LVAD, RVAD, BIVAD and ECMO.Equipment experience includes centrifugal and roller pumps, membrane and bubble oxygenators, cell savers, intra-aortic balloon pumps and warm/cold and blood/crystalloid cardioplegia systems.

Laboratory Animal Technician (LAT)The American Association of Laboratory Animal Science (AALAS)Supported experimental surgical or technical procedures on multiple species, including dose administration, sample collection, euthanasia, necropsy, anesthesia, surgical preparation, and recovery. Performed health assessments, analgesic management, and medical care under veterinary supervision. Maintained procedure rooms with appropriate supplies and sanitize as necessary. Ensured compliance with internal and external regulations and guidelines in accordance with facility standards. Maintained accurate documentation and research confidentiality. Member of Research Animal Studies Subcommittee.Member of Research Safety Committee.