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Robert Lew is a Clinical Operations Professional at Cytokinetics. He possess expertise in microsoft excel, microsoft word, clinical trials, data listing analysis, clinical research and 9 more skills.
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Senior Clinical Trial ManagerCytokinetics Jul 2024 - PresentSouth San Francisco, California, Us -
Clinical Operations ConsultantNkarta, Inc. Nov 2023 - Jun 2024South San Francisco, California, Us- Cross-functional Study Lead for company’s first auto-immune study- Management of CRO - Provide guidance for mitigations of risk for the Phase 1 Lupus Nephritis Trial- Oversee all aspects site feasibility and initiation of clinical sites in the United States and Australia- Development of screening enrollment strategies for equitable site enrollment in study -
Sr. Clinical Trial ManagerKezar Life Sciences Jul 2022 - Oct 2023South San Francisco, California, UsSuccessfully managed the Phase 1b/2 Lupus Nephritis trial through full enrollment. Completed CRO selection, and currently acting as study lead for the company’s leading global Phase 2b Lupus Nephritis study.- Cross-functional Study Lead for two studies in the same indication (Lupus Nephritis)- Completed feasibility and site selection for a study that crosses all regions- Assisted in protocol development for the Phase 2b study. Provided input during protocol development based on learning and risks from previous Phase 1b/2 study- Review study, vendor, and site budgets for both studies- Identify risks and issues, and work with teams to close and mitigate said risks and issues- Completed CRO selection -
Clinical Trial ManagerKezar Life Sciences Jul 2020 - Jul 2022South San Francisco, California, Us
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Clinical Trial ManagerMyokardia Apr 2019 - Jun 2020Brisbane, California, Us -
Clinical Research AssociateMyokardia May 2017 - Apr 2019Brisbane, California, UsActive team member for Multiple Phase II and Phase III Studies. Vendor manager for Central Labs, Cardiac Safety and external recruiting. Lead a data and values based cross functional team that builds community within the organization.
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Clinical Research AssociateRoche Molecular Systems Jan 2016 - Apr 2017Switzerland 🇨🇭 , ChClinical monitor for various studies over various life cycles, including the primary CRA for three sites over two studies. Provides assistance and guidance to sites as needed, and reviews subject data in the studies of the LIAT Point of Care analyzer/assay.• Perform monitoring activities including multiple studies including- Site Qualification, Initiation, Interim, and Close out visits• Prepare and completes monitoring reports for visits including SIV, IMV and COV reports• Review study protocols, reports and study logs for content and completion• Ensure that clinical research sites and their respective teams are in compliance with GCP and are follow the study protocol• Collect and ensure that all site and central documents are being collected and maintained• Review study data to ensure completeness and accuracy• Assisted various lifecycle groups with recognition across multiple team -
Clinical Trial AssistantOnyx Pharmaceuticals, Inc., An Amgen Subsidiary Jun 2014 - Dec 2015South San Francisco, Ca, UsAssist and manage various aspects of a global Phase III, multiple myeloma study (CLARION). Support the Clinical Operations team to successfully complete enrollment, and manage various issues as they arise. -
Clinical Research Coordinator AssistantUcsf Apr 2013 - Apr 2014San Francisco, California, UsManaged and assisted with documentation of multiple clinical research studies, including a Department of Defense Phase III waiver of informed consent study, focusing on resuscitation of trauma patients in respect to quantity, order and effects of blood products given in ER, OR and ICU. Gained valuable experience with site level clinical trial documentation, from enrollment to patient discharge. -
Outpatient Physical Therapy InternUc Davis Medical Center 2012 - 2012A 10-week internship focused on assisting physical and occupational therapists with focus on patient neurological needs. Gained considerable experience during patient rehabilitations. Patients were undergoing physical and occupational therapies for minor to serious neurological conditions. Selected Duties:• Worked closely with the Physical and Occupational Therapists who were administering patient rehabilitation, both pre- and post-surgeries. • Experience with HIPAA (Health Insurance Portability and Accountability Act) requirements utilized to protect important private information of patients and relevant research subjects and protocols.• Filed patient charts for physical therapists, and pulled files for next day work.• Cleaned and retrieved patient tools used for therapy during and after patient treatment sessions.
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Frontline SpecialistRei Sep 2008 - Jun 2010Seattle, UsHandled sales, returns and orders and inventory of outdoor products and placed special orders for customers. Selected Duties:• Applied professional phone skills by handling calls, messages and special holds on purchases for customers and vendors. Applied same skills with other REI stores while at Concord, CA. • Gained valuable experience working in a high-pace environment and working calmly during high stress. • Learned about new product from different company representatives. -
Sales AssociateLakeshore Learning Materials Mar 2007 - Nov 2007Carson, Ca, Us- Assisted parents and teachers with sales of learning material to help students- In charge of maintaining accurate inventory and product count- Experience running weekly program of children’s crafts while parents shopped
Robert Lew Skills
Robert Lew Education Details
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University Of California, DavisPhysiology And Behavior -
Diablo Valley College
Frequently Asked Questions about Robert Lew
What company does Robert Lew work for?
Robert Lew works for Cytokinetics
What is Robert Lew's role at the current company?
Robert Lew's current role is Clinical Operations Professional.
What is Robert Lew's email address?
Robert Lew's email address is rl****@****.rr.com
What is Robert Lew's direct phone number?
Robert Lew's direct phone number is +191668*****
What schools did Robert Lew attend?
Robert Lew attended University Of California, Davis, Diablo Valley College.
What are some of Robert Lew's interests?
Robert Lew has interest in Cooking, Exercise, Gardening, Investing, Nascar, Outdoors, Home Improvement, Electronics, Reading, Crafts.
What skills is Robert Lew known for?
Robert Lew has skills like Microsoft Excel, Microsoft Word, Clinical Trials, Data Listing Analysis, Clinical Research, Customer Service, Microsoft Office, Gcp, Biotechnology, Ip Release Analysis, Edc Review, Icf Review.
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