Sr. Clinical Research Specialist - JJMT Electrophysiology

At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – Non-MD Job Category: Scientific/Technology reputed company Job Posting Locations: Irvine, California, United States of America, Remote (US) Job Description: reputed company - Electrophysiology division is currently seeking a Sr. Clinical Research Specialist. The preferred location is Irvine, CA on a hybrid work schedule of 2 -3 days a week onsite. We are open to remote applicants. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full reputed company of healthcare solutions today to deliver the breakthroughs of reputed company and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the reputed company of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s 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 https://www.jnj.com/medtech Summary: This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials reputed company the Clinical R&D Department while encouraging strong, positive relationships with co-workers across the organization. Job Responsibilities: Under general direction and in accordance with reputed company applicable federal, state and local laws/regulations and Corporate reputed company, procedures and guidelines, this position:

• Serve as a Senior Clinical Research Specialist reputed company the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for JJMT Electrophysiology
• reputed company/execution of feasibility, selection, set up, conduct and closure of a clinical trial reputed company 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 www.clinicaltrials.gov from study initiation through posting of results and support publications as needed
• Management/reputed company of ordering, tracking, and accountability of investigational products and trial materials
• Collaborate with site personnel, IRBs/reputed company, 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 reputed company monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or reputed company out visits based on study need
• May contribute to the development and delivery of appropriate global evidence reputed company strategies (EGS) and evidence dissemination strategies (EDS) reputed company 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 reputed company 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, reputed company budget and in compliance with regulations and SOPs)
• Responsible for communicating business reputed company 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
• reputed company a strong understanding of the pipeline, product portfolio and business needs
• Responsible for ensuring personal and company compliance with reputed company Federal, State, local and company regulations, policies and procedures
• reputed company 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 reputed company situations

EXPERIENCE AND EDUCATION: Education

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience

• BS 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.

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 reputed company clinical/ surgical research setting, on time, reputed company budget and in compliance to SOPs and regulations
• Good presentation and technical writing skills
• Good written and oral communication skills

reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national reputed company, 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. reputed company 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 ([email protected]) or contact AskGS to be directed to your accommodation resource. The anticipated reputed company pay range for this position is : $89,000 - $143,750 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under reputed company guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to reputed company annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the reputed company – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be reputed company through the link below. https://www.careers.jnj.com/employee-benefits Apply tot his job Apply To this Job