1. JANIS SMITH, CCRA
PO Box 557  Pinole, CA 94564  510-220-6246  janisp02@gmail.com
CLINICAL RESEARCH ASSOCIATE
Diligent, results-driven clinical research professional with more than 20 years of success in clinical research and project
management across diverse sectors, poised to return to the field. Strong scientific and clinical background; well-versed in
managing all aspects of the research project lifecycle. Notable success in leading clinical trial research teams, coordinating
multicenter, multi-indication studies, and collecting, analyzing, and managing complex data to support statistical analysis
and reporting. Demonstrate outstanding interpersonal, collaborative, and decision-making skills, along with exceptional
customer service abilities. Excel in ever-changing, deadline-driven environments while working independently and as a
member of a high-performing team. Solid technical and computer skills.
 Demonstrated a wide range of expertise, which resulted in selection to serve as the study management team
leader for a complex clinical trial, while in the first year as a CRA.
 Managed a high-performing team comprised of 3 in-house clinical research associates (CRAs) and 7 contracted
CRAs across 15 study sites.
 Led the successful transition of a 1-year randomized, double-blinded efficacy study to a 3-year efficacy and chronic
rejection study.
 Commended for role in audit that determined a physician in the study was not adhering to the randomization
protocol.
Clinical Research Associate II | COHESION CORPORATION, Palo Alto, CA, 1997 - 1998
Led initiation of a multi-center, multi-indication, study for CoStasisTM
Hemostatic Device focused on controlling diffuse
capillary bleeding during surgical procedures. Established the foundation for initiation of a multi-center, multi-indication
feasibility study in support of CoSealTM
, a novel sealant device used to control surgical bleeding. Accurately maintained
written documentation related to studies. Designed protocols and developed case report forms.
 Identified and interviewed prospective investigators to support the CoStasisTM
study.
 Negotiated contracts and the CoStasisTM
study site budget. Initiated the central laboratory contract.
 Collaborated with PI to obtain IRB approval to support the first investigational center in the CoStasisTM
study.
 Observed and studied surgical procedures to prepare for instructing PIs during surgery in application of the
CoStasisTM
Hemostatic Device and CoSealTM
. Supported team in initiation of the CoSealTM
protocol.
 Prepared CoSealTM
demonstration kits and presented device to potential investigators.
Clinical Research Associate |CLINIMETRICS RESEARCH ASSOCIATES, REGIONAL, Various Locations, 1995 - 1997
Interacted with principal investigators and coordinators. Reported serious adverse events and quickly resolved
discrepancies. Prepared comprehensive site visit reports for sponsor companies.
CAREER HIGHLIGHTS
CLINICAL RESEARCH HISTORY
“Thank you for the work you have done with our site.
We very much appreciated your consistent
professionalism and attention to the many details in
running this trial.” Cindy Karpan, MSc, Coordinator,
Advanced Clinical Therapeutics
Expertise
Statistics
Quality Control
Clinical Research
Research/Analysis
Data Management
Project Management
Core Competencies
Team Leadership
Progress Monitoring
Good Clinical Practice
Regulatory Compliance
Regulatory Requirements
Adverse Events Reporting

2. JANIS SMITH, CCRA  510-220-6246  janisp02@gmail.com  Page 2
Continued…
 Employed expertise to monitor research sites to confirm protocol compliance, accurate and detailed source
documentation, drug accountability, and adherence with regulatory requirements.
 Monitored sponsor companies and indications including, Otsuka America Pharmaceutical, cardiology; Roche
Bioscience, renal transplantation/anti-rejection; Isis Pharmaceuticals, CMV retinitis in HIV; Roche Bioscience,
cardiac transplantation/anti-rejection; and Cor Therapeutics, cardiology.
Clinical Research Associate III | SYNTEX, Palo Alto, CA, 1993 - 1995
Accountable for management of 15 sites and 7 contract CRAs, while actively monitoring 5 sites. Oversaw protocol
development and revisions, case report form design, and renegotiation of study budgets. Negotiated site contracts and
budgets. Contributed to the successful design and execution of training sessions that supported incoming CRAs. Conducted
pre-study visits to orient research sites to protocols, study goals, and case report form completion requirements.
Monitored source document preparation and data management for statistical analysis. Confirmed drug accountability and
assessed drug-packaging needs. Engaged in extensive tracking and reported serious adverse events.
 Credited for role in transitioning from a 1-year, randomized, double-blind, efficacy study to a 3 year, double-blind
efficacy and chronic rejection study.
 Selected to serve as study management team leader after demonstrating a wide range of clinical research skills;
supported a 3-year, multicenter, phase III clinical trial in renal transplantation.
Staff Research Associate III | UNIVERSITY OF CALIFORNIA, San Francisco, CA, 1987 - 1993
Oversaw activities of a research lab that specialized in infectious disease and maternal-fetal immunology. Participated in
the Bay Area Perinatal Aids Center research study, which was a 5-year NIH grant that studied the transmission of HIV in
utero. Focused on T-cell immunology and function, the effects of HIV on pregnancy, the effects of pregnancy on the
progression of HIV, and transmission rate of HIV to infants.
 Wrote protocols including tissue culture, in vitro infection of cultures with the HIV virus, FACS, and maintenance
of a biosafety level II facility. Engaged in grant development, including submissions and updates.
 Designed training and delivered instruction to research fellows in the areas of procedures of tissue culture, FACS
staining, and BSL II protocols.
Marketing/Customer Service/Administrative | WESTAR MARINE SERVICES, San Francisco, CA, 2012 - Present
Customer Order Specialist/Expeditor | HOME DEPOT, Soquel, CA, 2010 - 2012
Personal Hiatus | CAREER SABATTICAL, 2008 - 2010
Captain/ Launch Deckhand / Deckhand | MARINE SERVICES, San Francisco, CA, 1998 - 2008
Deckhand/Dive Master | DRUMBEAT I CHARTERS, St. Thomas, US Virgin Islands, 1995 - 1997
Bachelor of Science, Zoology | UNIVERSITY OF CALIFORNIA, Davis, CA
ACRP Clinical Research Associate Certification, 2016
GCP for the Experienced CRA, ACRP CE, 2016
Mastering the Event Reporting Cycle, ACRP CE, 2016
The Drug Development Process, ACRP CE, 2016
Theory to Practice, Statistics, ACRP CE, 2016
Clinical Research Monitoring Workshop, SoCRA, 2006
ADDITIONAL PROFESSIONAL HISTORY