Senior Clinical Research Associate – Shockwave

Johnson & Johnson

Sr. Clinical Research Associate managing and meeting clinical study milestones for device innovation.

Posted 5/8/2026full-timeRemote • California, Minnesota • 🇺🇸 United StatesSenior💰 $106,000 - $170,200 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Manage and meet milestones of clinical studies in compliance with applicable clinical and regulatory standards and in alignment with business needs.
Accountable for clinical study and site management activities, coordination with cross-functional counterparts and contract research organizations (CROs) in global studies.
Participate in the design and execution of global studies for regulatory submissions, reimbursement and product adoption, including development of clinical study documents (protocol, case report forms, etc.), study implementation and data management.
Manage study preparation, activation, enrollment, submission, maintenance and closure activities.
Participate in administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets.
Ensures appropriate oversight of clinical study and study sites by internal and external resources including, but not limited to monitoring staff, CROs and core laboratories.
Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers.
Supervise training of investigators and site staff.
Evaluate clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents.
Ensure quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions.
Regularly communicate status updates to senior management and represent organization to study sites.

Requirements

What you’ll need

Bachelor’s Degree in a scientific field of study with a minimum of 5 years’ experience directly supporting clinical research for medical device studies
Prior experience with, or strong working knowledge of, Class III cardiovascular medical devices preferred
Working knowledge of Good Clinical Practice (GCP), FDA, ISO and other applicable regulations
Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting
ACRP or SOCRA clinical research certification preferred
Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
Ability to travel up to 25% domestically and internationally
High attention to detail and accuracy
Computer skills (MS Office products, word processing, spreadsheets, etc.)
Finance and budgeting knowledge
Good prioritization and organizational skills
Excellent critical thinking skills
Excellent influencing and negotiation skills
High energy and results-oriented individual who is mature and successful in a business environment
Proactive and “can do” attitude
Works effectively on large study teams and cross-functional teams
Effective written, verbal and presentation skills with all levels of management and organizations
Operates both as a team and independently, with adaptability to changing requirements
Ability to work in a fast-paced environment, managing multiple priorities

Benefits

Comp & perks

Employees are eligible to participate in the Company’s consolidated retirement plan (pension)
Employees are eligible to participate in the Company’s savings plan (401(k))
This position is eligible to participate in the Company’s long-term incentive program.
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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical study managementdata managementclinical study documentscontract negotiationadverse event evaluationcompliance reviewbudgetingmedical terminologyGCPFDA regulations

Soft Skills

communication skillsattention to detailorganizational skillscritical thinkinginfluencing skillsnegotiation skillsproactive attitudeteam collaborationadaptabilityresults-oriented

Certifications

ACRP certificationSOCRA certification