: Los Angeles County/USC Medical Center School of Nursing, Los Angeles, CA (Registered Nurse)

Transcription

1 CURRICULUM VITAE Name: Address: Phone Numbers: Cell: Blackberry: Office: Fax: Degrees and Training: : Los Angeles County/USC Medical Center School of Nursing, Los Angeles, CA (Registered Nurse) East Los Angeles College, Monterrey Park, CA (part of nurse s training, degree courses) Houston Baptist University, Houston, TX (part of perfusion training) Perfusion Associates, Houston, Texas (Certified Perfusion Technologist) Certification: Office of Emergency Services/ Search and Rescue Team State of California Certified Perfusion Technologist, State of Texas NASPE Exam Radiation Safety Course Department of Transportation/Hazardous Waste Certification - ACOSOG Auditor 2003, 2004 ACRP CCRC ACRP CCRA Licensure: Registered Nurse, State of Texas Appointments: FDA/CDRH cgmp Advisory Committee 2010 Miscellaneous: Heart of M.D. Anderson, M.D. Anderson Cancer Center October 2002 Page 1 of 5

2 Employment History: July, 2007 Present: The Methodist Hospital Research Institute 6565 Fannin Mail Station MGJ3-017 Houston, Texas Manager Quality Assurance/Regulatory Support Systems Management oversight of IND/IDE department Submission of INDs and IDEs, revisions, annual reports, safety reports FDA communications and file maintenance Protocol reviews Oversight of department administrative review process Management of clinical trials postings on TMHRI website and FDA website cgmp facility advisor NDA applications PET drugs Management oversight of investigational device process/cms Protocol management multi-center trials Management of IND/IDE study monitoring Member DSMB for IND/IDE studies Oversight of studies posted on Clinical Trials.gov website Investigator and Sponsor Responsibilities for IND and IDE Studies- PI Initiated Studies Everything You Wanted to Know About INDs and IDEs and Was Afraid to Ask Something From Nothing Building a Research Development and QA Department From Scratch Establishment of TMHRI DSMB (ORP/ITB Retreat education series) November, 1999 July, 2007: University of Texas, M.D. Anderson Cancer Center 1515 Holcombe Blvd. Houston, Texas, Regulatory Compliance Project Manager Submission of reports/requests to FDA: Submissions of INDs/IDEs to FDA Submission of revisions to existing INDs/IDEs to FDA Submission of requests to register new protocols under existing INDs/IDEs IND/IDE Annual Reports Protocol Reviews: Review and critique new protocols going to Clinical Research Committee Review device related protocols for Determination of Significant/Non-Significant Risk Attend/Chair Meetings with Investigators and Research Team: Concept Meetings Pre-IND Meetings Initiation Meetings Termination/Close-out Meetings Support Monitoring Team as needed: Page 2 of 5

3 Follow-up (when requested) with PI and research team if monitor has had to issue repeated queries without results Review all queries for monitoring team of MDACC IND trials Clinical Study Design Responsibilities of Investigators Audits: Informed Consent audits IRB requested (for cause) audits chemotherapy trials (targeted audits) Manager of Clinical Protocol Administration Department of Lymphoma/Myeloma Establish and organize regulatory department Regulatory files/binders Submission and revision process for protocols Auditing program existing protocols and ongoing audit process (all consents, pts on protocol, eligibility criteria) Oversee weekly QA meetings Evaluate all new protocols from auditing/regulatory standpoint Supervision of regulatory staff Set up proactive grants program Assisted in submission of grants for department including budget and technical proofing Set up system for centralized files of often used regulatory and grant files (i.e. CVs, CLIAs, Biographical sketches, licenses, department facilities budget purposes) Interface with monitors, auditors and FDA (PMAA audit 2004 no deviations found, no 483 issued) Senior Research Nurse Department of Surgical Oncology Conduct all aspects of clinical trials for Dept of Surgical Oncology Trained by ACOSOG to perform audits Performed audits at outside institutions throughout U.S. for ACOSOG FDA audit 2003 (for cause sponsor manufacturing issue) of clinical trial resulted in report of no deviations at our site no 483 issued Submitted protocol revisions and new protocols to IRB Back-up for department research nurse supervisor August 1996 May, 1999: Director of Clinical Research - Guidant, Houston (formally NeoCardia bought out by Guidant May, 1997) Write clinical protocols for IDE and CE Mark trials Create Case Report Forms for IDE and CE Mark trials Maintain clinical budget Establish contracts, investigator agreements and site agreements with clinical sites Maintain clinical administrative files: CVs, contracts, IRB approvals, consents, indemnity letters, lab certificates, correspondence with sites for US and International sites Responsible for conduct of clinical trials and assurance that they were conducted per Good Clinical Practices 21, CFR-812 and EN 540 Oversaw and performed pre-clinical trials (in association with animal facility at Baylor College of Medicine) Established SOP s for Clinical Events Committee and Safety and Data Monitoring Committees for US and International clinical trials oversaw meetings of these committees and wrote up reports of findings Assisted in writing IFUs for Centering Catheter and Source Wire; wrote IFU for Afterloader Page 3 of 5

4 Managed Purchase requisitions and check requests for clinical sites, clinical research coordinators and sales and marketing departments Conducted investigator training courses for PREVENT and INHIBIT studies Attended meetings with FDA for clinical trial planning/negotiations Extensive travel in US and Europe to monitor/audit/survey clinical sites Product technology: Intravascular Radiotherapy for Inhibition of Restenosis using beta radiation (P-32 Source Wires), Centering Catheters and modified high-dose rate Afterloaders March 1992 July 1996: Field Clinical Engineer - Ventritex, Inc. Sunnyvale, CA Assist with implant and follow-up of new products. Oversee clinical trials for new products. Troubleshoot problems regarding clinical and non-clinical products. Submit clinical data to in-house data management. Interface with physicians, hospital staff, sales and marketing, engineering and regulatory departments. Responsible for training of sales representatives on product technology. Product technology: Implantable defibrillators, implantable electrodes and patches, computerized programmers and cables, trans-telephonic transmitters and receivers. August 1984 March 1992: Clinical Trials Manager and Director: start-up companies in SF bay area: Cardiometrics, Inc and EP Technology, Inc Oversee clinical trials for new products. Troubleshoot problems regarding clinical and non-clinical products. Submit clinical data to appropriate entities (FDA, Venture capital organizations). Interface with physicians, hospital staff, sales and marketing, engineering and regulatory departments. Responsible for training of sales representatives on product technology. Wrote protocols and designed clinical trials. Additional information available upon request. June 1979 August 1984: Section of Cardiology, Baylor College of Medicine, Houston, TX RN, Section of Cardiology, Baylor College of Medicine Clinical Research Nurse for Electrophysiology Department Clinical Research Nurse for Cardiology Research Division Oversee clinical trials for Cardiology: patient scheduling, data management, oversee FDA audits, interface with industry representatives and physicians. Handle VIP patients and families. Hospital teaching of cath lab, surgery and rehab nurses. Supervisor of Cardiology Outpatient Clinics. Assisted in manuscript and abstract development. One of original members of the North American Society of Pacing and Electrophysiology (NASPE) and the Houston EP Society and served as Society Secretary for 2 years. June 1978 June 1979: Perfusion Technologist M. E. DeBakey Pump Team - Section of Cardiovascular Surgery, Baylor College of Medicine Operate heart/lung bypass equipment during surgical cases, maintain supply inventory June 1975 June 1978: Operating Room Nurse, Medical Center Del Oro Hospital, Houston, Texas Scrub, circulate, scheduling of OR staff and patient schedule. Note: This was a new hospital, assisted in OR design and ordering of all equipment, wrote OR SOPs, trained staff in policies and procedures and taught new/student nurses OR technique and case procedures June : Operating Room Nurse The Methodist Hospital, Houston, TX Page 4 of 5

5 Scrub and circulate OR cases, order supplies, training of new staff personnel April 1973 June 1974: Charge nurse, Surgical Trauma Unit Los Angeles County/ USC Medical Center, Los Angeles, CA Triage and trauma care of all surgical emergencies admitted to LAC/USCMC (21 bed trauma unit) June 1972 April 1973: Charge nurse, Surgical Pre-op and Post-op Teaching Ward, Los Angeles County/ USC Medical Center, Los Angeles, CA Staffing, patient care, development of patient teaching curriculum (for patients before and after surgery). Publication: Book Chapter: Acute and Chronic Testing of Pacemaker Thresholds and Sensitivity Gillette, P., & Griffin, J., Practical Cardiac Pacing. Baltimore, MD. Williams & Wilkins: 1986, Ch.10: pgs minute presentation at national conference: Society of Quality Assurance - April 23, 2009 Something from Nothing 60 minute presentation TMH Monthly Continuing education conference PI Initiated INDs October 15, minute presentation TMH Monthly Continuing education conference Everything you always wanted to know about INDs and IDEs and were afraid to ask October 28, 2009 Page 5 of 5