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- 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