Note: The job is a remote job and is open to candidates in USA. Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. The Sr. Clinical Research Associate will be responsible for managing and meeting milestones of clinical studies in compliance with applicable clinical and regulatory standards while coordinating with cross-functional counterparts and contract research organizations.

Responsibilities

• 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
• Evaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents
• Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions
• Regularly communicates with status updates to senior management and represents organization to study sites
• Other duties as assigned

Skills

• 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
• 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
• ACRP or SOCRA clinical research certification preferred
• Business Behavior
• Clinical Research and Regulations
• Clinical Trial Designs
• Clinical Trial Management Systems (CTMS)
• Clinical Trials
• Communication
• Give Feedback
• Laboratory Operations
• Medical Knowledge
• Mentorship
• Problem Solving
• Process Oriented
• Professional Ethics
• Project Integration Management
• Project Management
• Research and Development
• Research Ethics

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

Company Overview