ALEX RODAS2 3 2 6 D A S H W O O D A V E N U E • O A K L A N D , C A 9 4 6 0 5 • ( 4 1 5 ) 5 0 5 - 4 5 5 2

c b d _ m a n @ y a h o o . c o m   

WORK EXPERIENCE :Clinical Research Coordinator/Executive Assistant

University of California, San Francisco (UCSF), Div. of Gastroenterology San Francisco General Hospital - San Francisco, CA • May 2000 – present

Clinical Duties (Given Capsule Endoscopy Technician) – 2000 –June 2012

Schedule appointments for patients who need capsule endoscopies Obtain consent for the Given Capsule Endoscopy Perform clinical responsibilities for capsule endoscopy Coordinate all patient contact including insurance verification and scheduling Provide technical services as needed Coordinate visits and procedures for private patientsMedical Legal Coordinator Manage Dr. Cello’s medical-legal accounts (over 70 cases) Invoice and collect fee’s resulting in $200K/per year Type up expert reports as needed Set-up depositions and trial datesData Collection & Coordination Conducted clinical trials in the following therapeutic areas: Cholelithiasis, Gastro

Esophageal Reflux Disease, Neoplastic Polyps, Variceal Hemorrhage, Ulcerative Colitis, Inflammatory Bowel Syndrome and Morbid Obesity

Experienced study types from NIH Grants and Phases IIB – IV Outreach for new studies Register/randomize patients on institutional, industry-sponsored, and national

cooperative clinical trials and group studies; register patients with statistical centers Assist physicians in assuring inclusion/exclusion criteria during screening process by

verifying history and medical information on patients being entered into clinical trials Gather lab results, CT scans, x-rays, etc., as needed according to data and information

needs of specific protocols Establish rapport with patients and respond sympathetically to their needs Abstract data from medical records and enter medical information onto protocol

specific case report forms (CRFs), study flow sheets, and other required study forms Design CRFs, flow sheets, or other data collection forms Perform direct data entry into computer system Submit required data and data forms to statistical centers in accordance with accuracy

and timeliness requirements of protocol Obtain, process, ship, serum and tissue specimens Maintain accurate research charts and research study binders Monitor inventory of trial supplies and reorder when needed Maintain current versions of protocols in appropriate locations Maintain accurate study drug/device accountability records

Quality Assurance/Compliance Auditing Evaluate protocol study forms for completeness, accuracy and compliance to protocol Develop consistency checks and edits for error when appropriate Monitor the timeliness of data submission Assure timely review and completion of adverse events documentation and

submission according to the Code of Federal Regulations (CFR) and sponsor needs Attend site initiation and sponsor monitoring visits and act as intermediary between

services Prepare for and coordinate external audit visits by sponsors and regulatory agencies

and prepares documents required by external auditorsRegulatory Documentation Work with Principal Investigators to prepare/edit protocols for initial submission to

local IRB/CHR in accordance with FDA regulations, HIPPA and Good Clinical Practice (GCP)

Write/edit consent forms in accordance with established policy Submit protocols to appropriate committees according to legal policy Set up and maintain files of all regulatory documents, including adverse events

 Senior Community Health Representative/Research Assistant

Community Health Systems, UCSF, San Francisco, CA • August 1998 – May 2000

Tuberculosis Prevention Project Responsible for educating San Francisco County Jail’s inmates about Tuberculosis

disease and TB prevention Responsible for recruiting and interviewing jail inmates for a research study on TB

prophylaxis adherence Responsible for performing outreaches. Outreach for study participants done through

all types of agencies and community organizations Responsible for weekly data reports, graphs, and summaries for presentations and

investigator’s meetings Responsible for maintaining a database on research participants Responsible for locating study participants many of whom are from marginalized

populations Served as a liaison between Jail Health Services and Inmates Served as a liaison between jail personnel (Captains and Deputies) and study

personnel 

CREDENT IALS :Certified Clinical Research Coordinator (CCRC) – May 2014

Certified through the Association of Clinical Research Professionals (ACRP)Given Capsule Technician – August 2005

Certified through the GI Department at San Francisco General Hospital

EDUCAT ION:San Francisco State University (SFSU), San Francisco, CA

Bachelor of Arts, May 2003. Major: Biology

LANGUAGE SK ILLS :Fluent in reading, writing and speaking Spanish

COMPUTER SK ILLS :Operating Systems: Windows 2000/XP/NT Workstation & Server 4.0Applications: Microsoft Word, Excel, Access, PowerPoint, Publisher; Adobe PageMaker, Photoshop, Claris FileMaker Pro and others.Skills: Application development including database construction, spreadsheets and statistical analysis.

TRAINING CERTIFICATES/ CME CREDITS: Certificate of Training: Packing and shipping Infectious Substances Certificate of Completion: Endo Capsule Educational & Training Seminar (March

2011 – Olympus) Certificate of Achievement: Managing a Clinical Research Business (17 CME

credits) Certificate of Training: Basic Clinical Research Coordinator Clinical Trials Training Certificate of Training: Clinical Research Associate Training (April 2008, Medical

Research Management, Inc)HIPPA Training Program: 20 hrs. Complying with the Privacy Rule in Research by Medical Research Management, Inc.Clinical Research Associate Education and Training Program: Conducted by Medical Research Management, Inc an accredited provider through ACPE.

“Fundamentals of Clinical Research” April 2008

140 hour Training Program included the following topics: The drug research and development process, Identifying and reporting of non-

serious and serious adverse events, principles of data management and query resolution, protocol development, case report form design, and informed consent writing.

Good clinical practices 21 CFR 312 IND, 21 CFR 50 Protection of Human Subjects, 21 CFR 56 IRB, 45 CFR 46, 21 CFR 54 Financial Disclosure by Clinical Investigators, International Conference on Harmonization (E6) GCP Consolidated Guideline and (E2A) Clinical Safety Data Management.

Monitoring method and responsibilities: Systematic approach to monitoring, managing essential documents and clinical trial materials. Selecting investigators and conducting pre-evaluation, study initiation, interim and close out visits. Writing pre-visit letters, follow up letters and site visit reports. Performed five mock site visits utilizing case studies and wrote example monitoring reports.

Criteria for Course Completion: Complrehensive course examination, ICH/GCP regulatory examination, and performing a site monitoring visit identifying 80% of the deficiencies.

LEADERSHIP SK ILLS :  Associated Students Science/Engineering Representative of SF State

Participated in the Finance Committee, which controls the Associated Students budget

Participated in the Personnel Committee, which is responsible for the hiring of personnel for Associated Student programs

Co-creator of the Associated Students Bookloan Program

Treasurer of La Raza Health and Science Association Responsible for organizing weekly meetings for members Responsible for organizing events that dealt with health and science Responsible for fund-raising events on campus

 

SECURITY CLEARANCE:Jail Clearance for the Alameda County JailsJail Clearance for the San Francisco County Jails

PUBL ICAT IONS:Co-Authored Journal Articles

Thuan M. Duong, Edward S. Cruz, Alex Rodas, Cade McCall, Enrique Menéndez, Ellie R. Carmody, Jacqueline P. Tulsky, Mary Castle White“Strategies for Effective Education in a Jail Setting: the Tuberculosis Prevention Project”Health Promotion Practice, October 2003 Vol. 4 Issue 4

 Cello JP, Garcia RT, Nguyen MH, Rogers SJ, Rodas A, Trinh HN, Stollman NH, Schlueck G, McQuaid KR“Unsedated ultrathin EGD is well accepted when compared with conventional sedated EGD: a multicenter randomized trial.” Gastroenterology 2003; 125 – 1606-1612

Stanley J. Rogers MD, John P. Cello MD, Jan K. Horn MD, Allan E. Siperstein MD, William P. Schecter MD, Andre R. Campbell MD, Robert C. Mackersie MD, Alex Rodas CCRC, Huub T.C. Kreuwel PhD, and Hobart Harris MD. “Prospective Randomized Trial of Laparoscopic Cholecystectomy plus Laparoscopic Common Bile Duct Exploration (LC+LCBDE) versus Endoscopic Retrograde Cholangiopancreatography Sphincterotomy plus Laparoscopic Cholecystectomy (ERCP/S+LC) for Common Bile Duct Stone Disease.Archives of Surgery, Vol 145 (No. 1), Jan 2010

Co-Authored Journal Articles

Michael C. Larsen, Stanley Rogers, Alex Rodas, John P. Cello Mo1442 Long-Term Follow-Up of a Randomized Trial of Laparascopic Cholecystectomy and Laparascopic Common Bile Duct Exploration vs. ERCP With Sphincterotomy and Laparascopic Cholecystectomy for Common Bile Duct Stone DiseaseGastrointestinal Endoscopy 04/2011; 73(4).