Clinical Research Specialist - JJMT 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 https://www.jnj.com

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 Clinical Research Specialist.

This role's preferred location is in Irvine, California however we are open to remote candidates within the United States.

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.

This 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.

Job 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 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 J&J Medtech Electrophysiology under supervision;

· Participates in the 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);

· Assists in the 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;

· Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials;

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

· Interfaces and collaborates with Clinical Research Associates (CRAs);

· Assists in overseeing and supports the development and execution of Investigator agreements and trial payments;

· Assists in clinical data review to pre...