Headline

Clinical Research Manager at Stanford University School of Medicine

About

14+ years as an experienced Clinical Trial Manager and physician, skilled in leading clinical research operations from initial grant to final peer-reviewed publication. Worked across healthcare and clinical research, with roles at Santa Clara Valley Medical Center and a current managerial role at Stanford University.

Location

San Francisco Bay Area

Work experience

Clinical Research Manager at Stanford University School of Medicine, Apr 2016 - Present · 10 yrs 2 mos, Managed all aspects of phase 1 to 4 clinical trials including IND/IDE, NIH and Industry funded studies and Investigator initiated studies. Specialized in stem cell therapy protocols. Contract negotiations and budgets; Pharmacy protocols; Successful completion of 8 clinical trials. Supervision and training of research staff and, preceptor for annual Intern mentoring program. Selected Publications: Ghebremariam, Y. T., Cooke, J. P., Khan, F., Thakker, R. N., Chang, P., Shah, N. H., Nead, K. T., & Leeper, N. J. (2015). Proton pump inhibitors and vascular function: A prospective cross-over pilot study. Vascular medicine (London, England), 20(4), 309–316. https://doi-org.ucsf.idm.oclc.org/10.1177/1358863X14568444 Perin, E. C., Murphy, M. P., March, K. L., Bolli, R., Loughran, J., Yang, P. C., Leeper, N. J., Khan, F.,… Cardiovascular Cell Therapy Research Network (CCTRN) (2017). Evaluation of Cell Therapy on Exercise Performance and Limb Perfusion in Peripheral Artery Disease: The CCTRN PACE Trial (Patients With Intermittent Claudication Injected With ALDH Bright Cells). Circulation, 135(15), 1417–1428. https://doi-org.ucsf.idm.oclc.org/10.1161/CIRCULATIONAHA.116.025707

Clinical Study Lead and Trial Manager at Stanford University, School of Medicine, Division Of Vascular Surgery, 2016 - 2020 · 4 yrs, Stanford, California, United States, Oversee the planning, execution and closeout of 4 studies, coordinating with cross-functional teams and liaising with project leadership to ensure deliverables (timeline, quality etc.) are met. • Top enroller in California for the VOYAGER PAD trial, a multi-center, international, Phase III randomized double-blinded study sponsored by Janssen Pharmaceutical. o Setup and managed all aspects of clinical trial activities from start-up through database lock, ensuring GCP and relevant SOPs are followed. o Worked closely with internal Stanford teams and Sponsor/CROs. Conducted assessment of ankle-brachial index for all study participants. • VIEW-VLU multi-center, open label, phase 4 registry – sponsored by Provensis Ltd. Studying effects of Varithena on wound healing in the treatment of venous leg ulcers. • Lead coordinator for the industry funded EUCLID Study sponsored by AstraZeneca in collaboration with Duke Clinical Research Institute and CLI REVIVE Study sponsored by Aastrom Biosciences

(Clinical Studies / Data management) at Santa Clara Valley Medical Center, Nov 2010 - Mar 2012 · 1 yr 5 mos, Gastroenterology. Data management for Clinical Studies on Colonoscopy and Colorectal cancer. Extracted and entered data from 2005 to 2008 from patient's medical records into the department database on colonoscopies. Created the most comprehensive and largest database, among local county hospitals. Collaborated with residents and Principal Investigators. Abstracts (ddw 2012) : - Prevalence and Location of Synchronous Polyps in Early-Onset Colorectal Cancer - Ethnic Differences in Early-Onset Colorectal Cancer - Early-Onset Colorectal Cancer: Changes in Presentation and Survival over the past 20 years

Resident Medical Officer at Civil Hospital, Mar 1993 - Apr 1994 · 1 yr 2 mos, CRA for a retrospective Urology (VVF) clinical study in OB/GYN.

Internship at Jinnah Postgraduate Medical Center, 1990 - 1991 · 1 yr, Acquired various clinical experiences during medical training, internships in pediatrics, internal medicine, OB/GYN, ICU and cardiology. Taught and trained medical students, residents and nurses.

Education

Bachelor of Medicine, Bachelor of Surgery - MBBS, Medicine, Jinnah Sindh Medical University

Certificate, Biotechnology/ Biosciences, University of California, Santa Cruz