Clinical Research Associate II job at Johnson & Johnson in US National

Title: Clinical Research Associate II - Shockwave Medical

Location:

Remote USA

Full time

Job Description:

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: R&D Operations

Job Sub Function: Clinical Trial Project Management

Job Category: Professional

All Job Posting Locations: Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Clinical Research Associate II (CRA II) - Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

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/.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Clinical Research Associate II (CRA II) is responsible for facilitating in-house set up, activation, maintenance and closure of global clinical trials while gaining experience in clinical trial management processes. The CRA II will work closely with Investigators, Site Personnel and Vendors to ensure compliance with protocol and overall clinical objectives. In collaboration with the Clinical Management, the CRA II maintains consistent CRF data quality and discrepancy interpretation across sites. The CRA II will develop a basic understanding of the disease and indication.

Essential Job Functions

May participate in study design and study set up activities

May conduct site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct

May prepare and/or review monitoring reports per SOPs

Supports development of study training and may provide study site training to site personnel

Provides study training to internal employees as applicable

Assists in development of CRF design, CRF guidelines and supports database development when applicable

Develops study tools and guidelines to be utilized by study sites

Develops basic knowledge of the process used to evaluate and select potential investigators and sites

Develops basic knowledge of the process used to evaluate and select potential vendors as applicable

Interacts with field monitors/CRO CRAs, investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues

May perform data in clinical database for completeness, accuracy and performs data trending as needed

May analyze and evaluate clinical data gathered during research

Drafts informed consents as applicable

Reviews site's informed consent forms against the consent template for presence of all GCP requirements and protocol specific information and revises as needed. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand

Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy

Ensures audit preparedness

May be responsible for tracking Safety Reports for assigned sites

Responsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports

May initiate device shipments to ensure that study supplies are adequate for assigned studies and accurately accounted throughout study

Develops basic knowledge of the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies

May be responsible for initiating and tracking quarterly site payments and reconciling study invoices

Communicates status of trial to manager and team

May be responsible for development or revision of SOPs or work instructions

Appropriately represents functional area

Other duties as assigned

Requirements

Bachelor's degree in a scientific field of study, with a minimum of 2 years directly supporting clinical research

Must have excellent verbal and written communication skills

High attention to detail and organizational skills are necessary

Basic understanding of peripheral and coronary artery disease and therapies preferred

Working knowledge of GCP, FDA, ISO and other applicable regulations

Ability to travel 10-20% domestically and internationally

Experience with EDC Data Management Systems

Ability to work in a fast-paced environment while managing multiple priorities

ACRP or SOCRA clinical research certification preferred

Operate as a team and/or independently while demonstrating flexibility to changing requirements

Johnson & 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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning, Analytics Dashboards, Business Behavior, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials, Execution Focus, Laboratory Operations, Medical Knowledge, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics, Training Administration

The anticipated base pay range for this position is :

$87,000.00 - $140,300.00

Additional Description for Pay Transparency:

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 year

Sick 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 year

Holiday pay, including Floating Holidays -13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave - 80 hours in a 52-week rolling period10 days

Volunteer Leave - 32 hours per calendar year

Military Spouse Time-Off - 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits