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Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
Global exercise reimbursement.
Two weeks off (one of them fully paid) for volunteer work.
Biosense Webster, Inc. is recruiting for a Clinical Research Specialist located in Irvine, CA. At Biosense Webster, Inc. we have one goal — to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes. Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day. Learn more about Biosense Webster at www.biosensewebster.com and follow us on LinkedIn The Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while encouraging strong, positive relationships with co-workers across the organization. Key Responsibilities: Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Biosense Webster under supervision Participate in the feasibility, selection, set up, conduct and closure of the trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures. May serve as the main contact for clinical trial sites (e.g. site management). Assist in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports), ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed; Coordination and execution of ordering, tracking, and accountability of investigational products and trial materials Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel Assist in overseeing the development and execution of Investigator agreements and trial payments Assist in clinical data review to prepare data for statistical analyses and publications If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs) Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders Assist in tracking assigned project/study budgets Develop a strong understanding of the pipeline, product portfolio and business needs Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures Perform other duties assigned as needed Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but required guidance for complex situations. Qualifications Minimum of a bachelor’s degree preferably in Life Science, Physical Science, Nursing, or Biological Science required. OR any of the following requirements: BS with at least 2 years of relevant experience MS with at least 1 year of relevant experience Ph.D. with at least 1 year of relevant experience Experience in clinical research or equivalent is preferred. Relevant industry certifications are preferred (examples may include CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV). Medical device experience is a plus. CRO experience and site management and clinical site monitoring are assets. Experience delivering presentations is preferred. The primary location for this position is in Irvine, CA. Ability to travel approximately 20% depending on the phase of the program. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Working with Johnson & Johnson can change everything–including you. Explore impactful jobs, inclusive employee benefits, and how you can join us. Primary Location United States-California-Irvine-31 Technology Dr Organization Biosense Webster Inc. (6010) Job Function R&D Requisition ID 2206020754W
Child care benefits
Short term disability