Senior Clinical Research Associate (Medical Devices)

Location: Fully remote in the United States; up to 25% domestic and international travel required.

Salary: $106,000–$170,200 per year.

Company

Johnson & Johnson MedTech develops innovative, less invasive healthcare solutions, including Shockwave Medical’s intravascular lithotripsy products for calcified cardiovascular disease.

What you will do

• Design and execute global clinical studies supporting regulatory submissions, reimbursement, and product adoption.
• Manage study preparation, activation, enrollment, maintenance, and closure milestones.
• Coordinate internal stakeholders, CROs, monitoring staff, core laboratories, investigators, and clinical leaders.
• Evaluate clinical and adverse event data and prepare clinical study reports and technical documents.
• Negotiate contracts with hospitals, investigators, consultants, CROs, database firms, and suppliers.
• Maintain study quality through compliance reviews, device complaint oversight, audit review, and corrective actions.

Requirements

• Bachelor’s degree in a scientific field and at least 5 years of experience directly supporting clinical research.
• Working knowledge of Good Clinical Practice, FDA, ISO, and other applicable clinical and regulatory standards.
• Knowledge of international clinical research regulations, submissions, product launch, labeling, promotion, product vigilance, and medical device reporting.
• Strong medical terminology, written, verbal, presentation, interpersonal, critical-thinking, influencing, and negotiation skills.
• Experience with project coordination, budgeting, prioritization, organization, and computer tools including spreadsheets and word processing.
• Ability to work independently and cross-functionally in a fast-paced environment while managing multiple priorities.

Nice to have

• ACRP or SOCRA clinical research certification.

Culture & Benefits

• Inclusive work environment with equal employment opportunity and applicant accommodation support.
• Participation in a consolidated retirement plan, pension, and 401(k) savings plan.
• Eligibility for a long-term incentive program.
• Vacation, sick time, holidays, personal and family time, parental, bereavement, caregiver, volunteer, and military spouse leave.