Senior Clinical Research Associate – Shockwave Medical

About This Opportunity

We are representing a confidential medical device organization in their search for a Senior Clinical Research Associate. This fully remote position is based in the United States and offers the opportunity to work on innovative cardiovascular device clinical trials that are establishing new standards of care for complex cardiovascular disease.

Our talent team at Get A Job.ai is partnering with this organization to identify an experienced clinical research professional who can manage global clinical studies from design through completion while ensuring regulatory compliance and cross-functional coordination.

Responsibilities

• Lead the design and execution of global clinical studies for regulatory submissions and product adoption, including protocol development, case report forms, study implementation, and data management
• Manage the full study lifecycle including preparation, activation, enrollment, submission, maintenance, and closure activities
• Oversee clinical study monitoring performed by internal teams, CROs, and core laboratories to ensure quality and compliance
• Build and maintain strong relationships with key study investigators, medical advisors, and clinical leaders through direct engagement
• Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms, and external suppliers
• Supervise training of investigators, site personnel, and field clinical staff
• Evaluate clinical and adverse event data throughout study conduct and contribute to clinical study reports and technical documentation
• Maintain quality and compliance by reviewing device complaints, audit reports, and implementing corrective actions
• Provide regular study status updates to senior management and represent the organization to key stakeholders
• Coordinate with cross-functional teams to drive product development and clinical initiatives

What We're Looking For

• Bachelor's degree in a scientific field
• Minimum 5 years of direct clinical research experience
• Working knowledge of Good Clinical Practice (GCP), FDA regulations, ISO standards, and other applicable regulations
• Knowledge of FDA and international regulations including clinical strategy, GCPs, SOPs, submissions, product labeling, and medical device reporting
• ACRP or SOCRA clinical research certification preferred
• Strong written, oral, and interpersonal communication skills with proficient medical terminology knowledge
• Ability to travel up to 25% domestically and internationally
• High attention to detail and accuracy
• Proficiency with MS Office products, word processing, and spreadsheets
• Finance and budgeting knowledge
• Excellent prioritization, organizational, and critical thinking skills
• Strong influencing and negotiation abilities
• Proven ability to work effectively on cross-functional teams and independently
• Adaptability to manage multiple priorities in a fast-paced environment
• Proactive, results-oriented approach with high energy and professionalism

How We Work With You

Candidates should apply directly through Get A Job.ai. Our recruiting team will screen your application and qualifications. If you are a strong match, we will submit your profile to our client for consideration. Please do not contact the employer directly, as all communication and coordination will be managed through Get A Job.ai to ensure a professional and streamlined process.

Pay

Compensation details will be discussed with qualified candidates during the screening process.

Get A Job.ai is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees and candidates.