Clinical Research Associate II- Shockwave

Johnson & Johnson • Santa Clara, CA

9d • Remote

About The Position

Johnson & Johnson is hiring for a Clinical Research Associate 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.

Requirements

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

Nice To Haves

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

Responsibilities

• Facilitating in-house set up, activation, maintenance and closure of global clinical trials while gaining experience in clinical trial management processes.
• Working closely with Investigators, Site Personnel and Vendors to ensure compliance with protocol and overall clinical objectives.
• Maintaining consistent CRF data quality and discrepancy interpretation across sites in collaboration with Clinical Management.
• Developing a basic understanding of the disease and indication.
• Participating in study design and study set up activities.
• Conducting site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct.
• Preparing and/or reviewing monitoring reports per SOPs.
• Supporting development of study training and may provide study site training to site personnel.
• Providing study training to internal employees as applicable.
• Assisting in development of CRF design, CRF guidelines and supporting database development when applicable.
• Developing study tools and guidelines to be utilized by study sites.
• Developing a basic understanding of the process used to evaluate and select potential investigators and sites.
• Developing a basic understanding of the process used to evaluate and select potential vendors as applicable.
• Interacting with field monitors/CRO CRAs, investigators and study coordinators through frequent communication (written and verbal) and maintaining effective management of study issues.
• Performing data in clinical database for completeness, accuracy and performing data trending as needed.
• Analyzing and evaluating clinical data gathered during research.
• Drafting informed consents as applicable.
• Reviewing site’s informed consent forms against the consent template for presence of all GCP requirements and protocol specific information and revising as needed. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand.
• Coordinating and reviewing regulatory documents from study sites; ensuring completeness and accuracy.
• Ensuring audit preparedness.
• Tracking Safety Reports for assigned sites.
• Authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports.
• Initiating device shipments to ensure that study supplies are adequate for assigned studies and accurately accounted throughout study.
• Developing a basic understanding of the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies.
• Initiating and tracking quarterly site payments and reconciling study invoices.
• Communicating status of trial to manager and team.
• Developing or revising SOPs or work instructions.
• Appropriately representing functional area.
• Other duties as assigned.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level