Clinical Research Associate II- Shockwave Medical

Johnson & Johnson•Santa Clara, CA

6d•$87,000 - $140,300•Remote

About The Position

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 Research Manager, 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.

Requirements

Bachelor’s degree in science or healthcare with a minimum of 2 years of medical device industry experience directly supporting clinical research in a Sponsor role
Must have excellent verbal and written communication skills
High attention to detail and organizational skills are necessary
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
Operate as a team and/or independently while demonstrating flexibility to changing requirements

Nice To Haves

Basic understanding of peripheral and coronary artery disease and therapies preferred
ACRP or SOCRA clinical research certification preferred

Responsibilities

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
Participate in the review of monitoring visit reports for completeness
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
Develop 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
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 revisions 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, facilitates translation as needed
Ensure study records are auditable in-house
Responsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports
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

Benefits

Subject to the terms of their respective plans, employees are 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.
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year