Clinical Research Associate II- Shockwave (Reducer)

Johnson & Johnson • Santa Clara, CA

21h • Remote

About The Position

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.

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.
• 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

• 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 the Clinical Research Manager.
• 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.
• Participating in the review of monitoring visit reports for completeness.
• 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.
• 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 revisions 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, facilitating translation as needed.
• Ensuring study records are auditable in-house.
• Authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports.
• Developing a 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.
• Communicating status of trial to manager and team.
• May be responsible for development or revision of 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
• Number of Employees: 5,001-10,000 employees