Sr. Clinical Research Specialist - Electrophysiology

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex 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 spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Irvine, California, United States of America

Job 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 & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex 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 spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow 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 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 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 

JOB SUMMARY

This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials

within the Clinical R&D Department while fostering strong, productive relationships with colleagues

across the organization.

DUTIES & 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:

 Serves 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, Inc;

 Oversees/executes 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);

 Contributes towards development of clinical trial documents (e.g. study protocol, informed

consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….);

 Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through

posting of results and support publications as needed;

 Manages/oversees ordering, tracking, and accountability of investigational devices and trial

materials;

 Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company

personnel;

 Interfaces, collaborates and oversees Clinical Research Associates (CRAs);

 Oversees and supports the development and execution of Investigator agreements and trial

payments;

 Is responsible for clinical data revie