Principal Clinical Research Associate- Shockwave (Reducer)

Johnson & Johnson Innovative Medicine • Santa Clara, CA

11d • $125,000 - $201,250 • 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/. 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 Principal Clinical Research Associate (CRA) is responsible for the day-to-day management of a global clinical study. The Principal CRA will be accountable for project management activities, oversight of multiple vendors and for conducting a global clinical study in compliance with applicable clinical and regulatory standards and in alignment with the business needs. The individual is a subject matter expert in clinical research and this work is accomplished with minimal oversight, requires frequent contact with internal and external customers and is critical to the success of the business.

Requirements

• Bachelor’s Degree or equivalent experience in a scientific field of study
• Minimum 10 years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
• Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred.
• Ability to travel 10-20% domestically and internationally.
• Thorough knowledge of Good Clinical Practice (GCP) is required.
• Working knowledge of GCP, FDA, ISO and other applicable regulations.
• Experience with EDC Data Management Systems.
• Knowledge and experience in supporting device pre- and/or post-market clinical studies is required, including experience running IDE trials.
• Able to manage multiple project teams.
• 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.
• Must have excellent verbal and written communication skills.
• High attention to detail and accuracy.

Nice To Haves

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

Responsibilities

• Responsible for organizing, communicating and evaluating team objectives for clinical studies.
• Participates in study design and study preparation activities, as applicable.
• Develops and revises clinical trial documentation including clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions.
• Participates or leads the process to evaluate and select potential investigators and sites.
• Participates or leads the process to evaluate and select potential vendors as applicable.
• Conducts or oversees site visits as required (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct.
• Develops and revises site training tools, interprets clinical data, manages investigational sites, develops tracking tools and performs other clinical activities as needed during clinical study conduct.
• Leads clinical study teams focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies.
• Manages project timelines and vendor performance to meet departmental and corporate goals.
• Monitors and tracks clinical trial progress and provides status update reports.
• Manages study budget, payment process and reconciliation of invoices for all clinical trial vendors including investigative sites when applicable.
• Oversees work produced by junior clinical team members.
• Manages all clinical trial vendors (e.g., IRB, IVRS, central/core labs, such as angiogram, ultrasound, or central ECG).
• Analyzes and evaluates clinical data gathered during research.
• Leads, prepares and reviews project and study-related documents including: informed consent forms, investigational brochures, case report forms, monitoring plans, synopses, protocols and amendments, and other appropriate sections for studies conducted under Investigational Device Exemption (IDE) or 510(k) application.
• Responsible for authoring internal documents and clinical study reports and assisting with clinical evaluation reports.
• Develops and revises annual, interim, and final reports and clinical sections of Pre- or Post-Market Approval submissions.
• Coordinates the design, format and content of CRFs, study guides, study reference binders, and forms including participating in the EDC and IVRS specification process and UAT.
• Coordinates and manages Investigational Product including overall accountability and reconciliation.
• Responsible for selection of CRO study staff and coordinating training including documentation.
• Leads the review of clinical data at the CRF, data listing, and report table levels.
• Represents Clinical Affairs at the Project Team level for individual studies, as appropriate
• Identifies and escalates site, vendor and study related issues to supervisor, as appropriate
• Oversees clinical and adverse event data evaluation during the conduct of the study and for completion of clinical study reports.
• Working knowledge of CEC and DSMBs.
• Manages training of investigators, site staff, and SWMI clinical staff.
• Oversees quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective and preventative actions.
• 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: Senior