Coordinate and Facilitate (non-regulated) new employee orientation.

• Liaison with sponsors to define and manage project requirements and timelines. • Guide team members to ensure study timelines are met. • Ensure team compliance with company and study specific protocols, study specific plans, and FDA regulations. • Write and Maintain project specific documentation in compliance with FDA regulations. • Review study specific Protocols to Create study specific Data Management plans,and other study related documents. • Consult for US Army Data Manager • Assist Cleveland Clinic with data validation processes.

• Liaison with sponsors to define and manage project requirements and timelines. • Present at various industry events, representing the Cleveland Clinic. • Provide onsite orientation to newly selected trial sites. • Liaison with national and international clinical sites (physicians or nurse coordinators, sponsors, CROs, project managers, and site monitors) • Liaison with other C5 departments to define and manage project requirements and timelines.PROFESSIONAL EXPERIENCE (cont’d): • Guide team members to meet study timelines. • Ensure departmental FDA compliance with study specific protocols, study specific plans, and government regulations. • Formulate and maintain FDA, GCDMP, GCP, ICH compliance documentation • Review Protocols and Create study specific Data Management plans, Case Report Forms and CRF instructions, data edit check plans, Mock Data, DCF wording, and other Data Management documents. • Maintain study related activity documentation (formulate documentation, maintain Files, organize files, etc). • Ensure quality assurance within department. • Audit Escort for Sponsor Audits. • Orientation Committee member

• Liaison with sponsors to define and manage project requirements and timelines.• Liaison with other C5 departments to define and manage project requirements and timelines.• Review protocols; create study data collection forms and instructions, and other trial documents.• Aid in the establishment and coordination of Study sites, Core Laboratory Documents, Databases, and communication/documentation for new studies.• Reference and Correspondence point person for trials’ new study sites and for ongoing study sites• Attend Conference calls to update Study Sponsors, CRO, Study Coordinators, and C5 teams of each study’s progress• Review and contribute to clinical trial protocols• Provide study specific IVUS training to Research Coordinators, Project Managers, Clinical Research Associates, sponsors, physicians and technicians• Direct other team members to ensure study timelines are met.• Organize, consolidate, and maintain records for research activities in the department.• Ensure quality assurance within team• Write SOPs, analysis definitions, training documents for new hires.• Order and maintain lab supplies• Event Coordination as needed to include room scheduling, agendas, etc.• Continuing prior duties as Research Technician in daily work routine

• Coordinate 600 pt 160 center IVUS Clinical Trial (PERISCOPE)• Coordinate 800 pt 125 center IVUS Clinical Trial (STRADIVARIUS)• Primary and Secondary Qualitative and Quantitative assessment of intravascular ultrasound images for CCF and clinical trial studies• Technical Support of intravascular ultrasound procedures performed in the CCF Cath lab• Interpretation and instruction of IVUS procedures to site physicians, CCF physicians, employees and visitors (national and international)• Train and support research fellows in IVUS interpretation and analysis.• Participate in and represent the IVUS core lab at presentations to Pharmaceutical companies, CROs, and study teams including Physician/coordinator education• Maintenance of CCF ultrasound tape library and databases• Audit Escort for Sponsor Audits• SOP, IOP administrator• Fire safety administrator• Radiation Safety administrator• Meeting Planning

• Perform quantitative and qualitative morphological analysis of aortic aneurysms and aortic endografts from CT and X-ray images• Data entry

• Perform Scrub Nurse duties in extensive primary and re-operative Cardiothoracic and Thoracic Surgeries, with Drs. Cosgrove, Lytle, Petterson, Smedira, Navia, Rice, Murthy, and Gillinov.• Cardiothoracic procedures include heart transplant, Primary and repeat coronary bypass, coronary and pulmonary valve repair and replacement, Maze, DOR, L-VAD, R-VAD, and Bi-VAD procedures, IABP placement, Mediastianal flaps.• Thoracic Procedures include Lung Transplant, Thoracic aneurysm repair, Lobe Excision, mediastinal Cancer staging, Tracheotomy, and Esophageal Reconstruction.• Training and orientation of new Scrub nurses, and residents

• Scrub Nurse duties in various specialties including:• Cardiac: pacemakers-single and double lead, pericardial window• Thoracic: lobe excision, cancer staging,• Peripheral Vascular: AAA repair, stenting, stent-grafts, bypass, fistula insertion• Neurological: Intracranial, spinal, peripheral repairs• Orthopedic: Hip, knee, shoulder, replacement, fracture repairs• Intra/Extra ocular: cataracts, strabismus correction, windows• ENT: Sinus endoscopies, turbinate removal, cyst removal, sinus reconstruction in traumatic injury cases• Plastic, Reconstructive (facial, and general), Mohs with reconstruction• OB: C-section (emergency and routine)• Gyn: Hysterectomy (Laparoscopically assisted and ‘open’), myectomy, sling repair, various laparoscopic procedures• General surgery, Lap/open Chole, Lap/open Appendectomy, Bowel resection (Various types), various soft tissue excisions, removal of foreign bodies, EGD and Colonoscopy.• Training and orientation of new Scrub Nurses and students.• Revision of Standard Operating Procedures• Assist in development of, and primary scrub Nurse in Cleveland Endovascular Institute with Dr. Curtis Lockhart