Senior Clinical Research Specialist JJMT Electrophysiology at Johnson & Johnson

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function: Clinical Development & Research Non-MDJob Category:Scientific/TechnologyAll Job Posting Locations:Irvine California United States of AmericaJob Description:Our J&J MedTech Electrophysiology clinical team is currently recruiting for a Sr. Clinical Research Specialist. This role is located in Irvine California.Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.Are you passionate about improving and expanding the possibilities of Cardiovascular Ready to join a team thats reimagining how we heal Our Cardiovascular team develops leading solutions for heart recovery electrophysiology and stroke. You will join a proud heritage of continually elevating standards of care for stroke heart failure and atrial fibrillation (AFib) patients.Your unique talents will help patients on their journey to wellness. Learn more at Summary:This Senior 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:Under general direction and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position: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;Oversight/execution of feasibility selection set up conduct and closure of a clinical trial within the allocated countries in accordance with the ICH-GCP applicable legislation and Company Standard Operating Procedures;May serve as the primary contact for clinical trial sites (e.g. site management);Contribute towards development of clinical trial documents (e.g. study protocol informed consents CRF monitoring plan study manual investigator brochure annual reports) ensure registration on from study initiation through posting of results and support publications as needed;Management/oversight of ordering tracking and accountability of investigational products and trial materials;Collaborate with site personnel IRBs/ECs contractors/vendors and company personnel;Supervise the development and execution of Investigator agreements and trial payments;Responsible for 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;May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;If applicable as part of a clinical trial may provide on-site procedural protocol compliance and data collection support to the center;Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;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;Support project/study budget activities as assigned;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 mentorship for complex situations.Qualifications:EducationMinimum of a Bachelors Degree preferably in Life Science Physical Science Nursing or Biological Science required.ExperienceBS with at least 4 years MS with at least 3 years PhD with at least 2 years of relevant experience required.Previous medical device Clinical Research experience in the area of interventional cardiology or electrophysiology is strongly preferred.Relevant industry certifications preferred (i.e. CCRA CCRC CCRP RAC CDE GCP ISO 14155 MDR MEDDEV).Clinical/medical background a plus.Up to 20% travel is required.Functional and Technical Proficiencies:Good understanding of clinical research science and processes clinical trends and global clinical trial regulations;Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting on time within budget and in compliance to SOPs and regulations;Good presentation and technical writing skills;Good written and oral communication skillsJohnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.Required Skills:Preferred Skills:Clinical Data Management Clinical Evaluations Coaching Critical Thinking Data Savvy Drug Discovery Development Ethical and Participant Safety Considerations Good Clinical Practice (GCP) Industry Analysis Medicines and Device Development and Regulation Regulatory Affairs Management Relationship Building Research Documents Safety-Oriented Scientific Research Standard Scientific Processes and Procedures Technologically SavvyThe anticipated base pay range for this position is :$109000.00 - $174800.00Additional Description for Pay Transparency:Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:Vacation 120 hours per calendar yearSick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar yearHoliday pay including Floating Holidays 13 days per calendar yearWork Personal and Family Time - up to 40 hours per calendar yearParental Leave 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave 80 hours in a 52-week rolling period10 daysVolunteer Leave 32 hours per calendar yearMilitary Spouse Time-Off 80 hours per calendar yearFor additional general information on Company benefits please go to: - Experience:Senior IC Key Skills CSS,Cloud Computing,Health Education,Actuary,Building Electrician Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 109000 - 174800