Alex Rodas has over 20 years of experience as a clinical research coordinator and executive assistant at UCSF. He has extensive experience coordinating clinical trials in various therapeutic areas and managing all aspects of clinical research studies including participant recruitment and screening, data collection, regulatory documentation, and quality assurance. Rodas holds certifications as a Clinical Research Coordinator and Given Capsule Technician. He has co-authored several peer-reviewed journal articles on clinical research studies.

1. ALEX RODAS
2 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
WO R K E X P E R I E N C E :
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 patients
Medical 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 dates
Data 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

2. 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 auditors
Regulatory 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
C R E D E N T I A L S :
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

3. E D U CAT I O N :
San Francisco State University (SFSU), San Francisco, CA
Bachelor of Arts, May 2003. Major: Biology
L A N G UAG E S K I L L S :
Fluent in reading, writing and speaking Spanish
C O M P U T E R S K I L L S :
Operating Systems: Windows 2000/XP/NT Workstation & Server 4.0
Applications: 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.

4. Criteria for Course Completion: Complrehensive course examination,
ICH/GCP regulatory examination, and performing a site monitoring visit
identifying 80% of the deficiencies.
L E A D E R S H I P S K I L L S :
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 Jails
Jail Clearance for the San Francisco County Jails
P U B L I CAT I O N S :
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

5. 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 Disease
Gastrointestinal Endoscopy 04/2011; 73(4).

6. 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 Disease
Gastrointestinal Endoscopy 04/2011; 73(4).