[Remote] Principal Clinical Research Associate- Shockwave (Reducer)

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 Principal Clinical Research Associate will be responsible for the day-to-day management of a global clinical study, overseeing project management activities, vendor oversight, and ensuring compliance with clinical and regulatory standards.

Responsibilities

• Responsible for organizing, communicating and evaluating team objectives for clinical studies
• Participates in study design and study preparation activities, as applicable
• Develops and revises clinical trial documentation including clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions
• Participates or leads the process to evaluate and select potential investigators and sites
• Participates or leads the process to evaluate and select potential vendors as applicable
• Conducts or oversees site visits as required (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct
• Develops and revises site training tools, interprets clinical data, manages investigational sites, develops tracking tools and performs other clinical activities as needed during clinical study conduct
• Leads clinical study teams focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies
• Manages project timelines and vendor performance to meet departmental and corporate goals
• Monitors and tracks clinical trial progress and provides status update reports
• Manages study budget, payment process and reconciliation of invoices for all clinical trial vendors including investigative sites when applicable
• Oversees work produced by junior clinical team members
• Manages all clinical trial vendors (e.g., IRB, IVRS, central/core labs, such as angiogram, ultrasound, or central ECG)
• Analyzes and evaluates clinical data gathered during research
• Leads, prepares and reviews project and study-related documents including: informed consent forms, investigational brochures, case report forms, monitoring plans, synopses, protocols and amendments, and other appropriate sections for studies conducted under Investigational Device Exemption (IDE) or 510(k) application
• Responsible for authoring internal documents and clinical study reports and assisting with clinical evaluation reports
• Develops and revises annual, interim, and final reports and clinical sections of Pre- or Post-Market Approval submissions
• Coordinates the design, format and content of CRFs, study guides, study reference binders, and forms including participating in the EDC and IVRS specification process and UAT
• Coordinates and manages Investigational Product including overall accountability and reconciliation
• Responsible for selection of CRO study staff and coordinating training including documentation
• Leads the review of clinical data at the CRF, data listing, and report table levels
• Represents Clinical Affairs at the Project Team level for individual studies, as appropriate
• Identifies and escalates site, vendor and study related issues to supervisor, as appropriate
• Oversees clinical and adverse event data evaluation during the conduct of the study and for completion of clinical study reports. Working knowledge of CEC and DSMBs
• Manages training of investigators, site staff, and SWMI clinical staff
• Oversees quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective and preventative actions
• Other duties as assigned

Skills

• Bachelor's Degree or equivalent experience in a scientific field of study
• Minimum 10 years' experience directly supporting clinical research or relevant experience in medical/scientific area. Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred
• Ability to travel 10-20% domestically and internationally
• Thorough knowledge of Good Clinical Practice (GCP) is required
• Working knowledge of GCP, FDA, ISO and other applicable regulations
• Experience with EDC Data Management Systems
• Knowledge and experience in supporting device pre- and/or post-market clinical studies is required, including experience running IDE trials
• Able to manage multiple project teams
• Ability to work in a fast-paced environment while managing multiple priorities
• Operate as a team and/or independently while demonstrating flexibility to changing requirements
• Must have excellent verbal and written communication skills
• High attention to detail and accuracy
• Basic understanding of peripheral and coronary artery disease and therapies preferred
• ACRP or SOCRA clinical research certification is preferred
• Analytical Reasoning
• Clinical Research and Regulations
• Clinical Trial Designs
• Clinical Trial Management Systems (CTMS)
• Clinical Trials
• Communication
• Data Savvy
• Laboratory Operations
• Organizing
• Problem Solving
• Productivity Planning
• Professional Ethics
• Project Integration Management
• Quality Assurance (QA)
• Regulatory Compliance
• Research and Development
• Research Ethics
• Standard Operating Procedure (SOP)

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

Company H1B Sponsorship