Principal Clinical Research Associate – Shockwave

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Accountable for organizing, communicating, and assessing team objectives for clinical studies.

• Engages in study design and preparation activities as necessary.

• Creates and revises clinical trial documentation, including the development of clinical trial protocols, case report forms (CRFs), and IRB/Ethics submissions.

• Participates in or leads the evaluation and selection process for potential investigators and sites.

• Participates in or leads the assessment and selection of potential vendors as needed.

• Conducts or supervises site visits as required (pre-study, initiation, interim, and close-out visits) to ensure compliance with the protocol, accurate and thorough data collection, and proper study conduct.

• Develops and updates site training resources, interprets clinical data, manages investigational sites, creates tracking tools, and performs additional clinical activities as required during the conduct of clinical studies.

• Leads clinical study teams focused on executing clinical programs in accordance with applicable regulations, guidelines, and policies.

• Oversees project timelines and vendor performance to achieve departmental and corporate objectives.

• Monitors and tracks the progress of clinical trials and provides status update reports.

• Manages the study budget, payment processes, and reconciliation of invoices for all clinical trial vendors, including investigative sites as applicable.

• Supervises the work of junior clinical team members.

• Oversees all clinical trial vendors (e.g., IRB, IVRS, central/core labs, such as angiogram, ultrasound, or central ECG).

• Analyzes and evaluates clinical data collected 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 relevant sections for studies conducted under Investigational Device Exemption (IDE) or 510(k) applications.

• Responsible for authoring internal documents and clinical study reports, as well as 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 User Acceptance Testing (UAT).

• Coordinates and manages Investigational Product, encompassing overall accountability and reconciliation.

• Responsible for selecting CRO study staff and coordinating their 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 supervisors when appropriate.

• Oversees the evaluation of clinical and adverse event data during the study's conduct and for the completion of clinical study reports.

• Possesses a working knowledge of Clinical Event Committees (CEC) and Data Safety Monitoring Boards (DSMBs).

• Manages the training of investigators, site staff, and SWMI clinical staff.

• Ensures quality by maintaining compliance, reviewing device complaints, examining audit reports, and implementing corrective and preventative measures.

• Performs other duties as assigned.

⛳️ Requirements

• Bachelor's Degree or equivalent experience in a scientific field of study.

• At least 10 years of experience directly supporting clinical research or relevant experience in the medical/scientific domain.

• Minimum of 1 year in a role directly managing trials and projects; 2-3 years preferred.

• Willingness to travel 10-20% domestically and internationally.

• Comprehensive knowledge of Good Clinical Practice (GCP) is essential.

• Familiarity with GCP, FDA, ISO, and other relevant regulations.

• Experience with Electronic Data Capture (EDC) Data Management Systems.

• Basic understanding of peripheral and coronary artery disease and therapies is preferred.

• Required experience in supporting device pre- and/or post-market clinical studies, including running IDE trials.

• ACRP or SOCRA clinical research certification is preferred.

• Capable of managing multiple project teams.

• Ability to thrive in a fast-paced environment while handling multiple priorities.

• Excellent verbal and written communication skills are mandatory.

• Strong attention to detail and accuracy.

🏝️ 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.

• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; for employees residing in the State of Colorado – 48 hours per calendar year; for employees residing 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.