Clinical Research Associate II- Shockwave (Reducer)

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:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Johnson & Johnson is hiring for a Clinical Research Associate II- Shockwave (Reducer) 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/.

Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the innovative Shockwave Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide.

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.

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
• 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

Qualifications

• 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
• 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 and 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 email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills: