Senior Clinical Research Associate - Shockwave Medical

Johnson & Johnson MedTech; Santa Clara (CA); Remote; USD 89,000 - 144,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Research Associate to join their innovative team. This fully remote role offers the opportunity to manage cutting-edge clinical studies focused on less invasive treatments for complex cardiovascular diseases. You will play a crucial role in ensuring compliance with regulatory standards while collaborating with cross-functional teams and external resources. This position not only promises a dynamic work environment but also the chance to make a significant impact on healthcare solutions that improve lives. If you are passionate about clinical research and ready to take on new challenges, this is an exciting opportunity for you.

Benefits

Performance Bonuses

Retirement Plans

Paid Time Off

Inclusive Hiring Practices

Qualifications

• 5+ years of experience in clinical research support.
• Strong knowledge of GCP, FDA, and ISO regulations.

Responsibilities

• Manage clinical studies ensuring compliance and coordination.
• Evaluate clinical and adverse event data for quality assurance.

Skills

Clinical Research

GCP Knowledge

FDA Regulations

Communication Skills

Organizational Skills

Education

Bachelor’s Degree in a Scientific Field

Tools

MS Office

Job description

Senior Clinical Research Associate - Shockwave Medical

Join to apply for the Senior Clinical Research Associate - Shockwave Medical role at Johnson & Johnson MedTech.

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.

Job Function

R&D Operations

Job Sub Function

Clinical Trial Project Management

Job Category

Professional

Location

Santa Clara, California, United States of America

Job Description

Johnson & Johnson is hiring for a Senior Clinical Research Associate (Remote) to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

We are developing the next generation of smarter, less invasive, more personalized treatments, including Intravascular Lithotripsy (IVL) for complex calcified cardiovascular disease. The Sr. CRA will manage clinical studies, ensuring compliance with standards, coordinating with CROs, and working independently once projects are assigned.

Essential Job Functions

• Participate in design and execution of global studies for regulatory submissions, reimbursement, and product adoption.
• Manage study preparation, activation, enrollment, submission, and closure.
• Coordinate with cross-functional teams and external resources.
• Manage relationships with investigators and clinical sites.
• Negotiate contracts and supervise training of staff.
• Evaluate clinical and adverse event data and ensure quality and compliance.
• Communicate study status to senior management.

Requirements

• Bachelor’s Degree in a scientific field with at least 5 years’ experience supporting clinical research.
• Knowledge of GCP, FDA, ISO regulations.
• Preferred: ACRP or SOCRA certification.
• Strong communication skills, ability to travel up to 25%.
• Proficiency in MS Office, budgeting, and organizational skills.

Pay Transparency

• Salary range: $89,000 - $143,750 (US); $103,000 - $165,600 (Bay Area).
• Includes performance bonuses, benefits, retirement plans, and paid time off.

Johnson & Johnson is an Equal Opportunity Employer. We support inclusive hiring and accommodations for applicants with disabilities.