Clinical Research Specialist - Mentor, Inc.

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:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
Irvine, California, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Clinical Research Specialist to support our Mentor business.  This role will work a Flex/Hybrid schedule with 3 days per week on-site and must be located within a commutable distance of Irvine, CA.  The role may also require up to 25% travel depending on the phase of the program.

Purpose: The 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.

You will be responsible for:


* 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 Operating Company 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 prepare ...