Principal Clinical Research Associate – Shockwave, Reducer

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

📋 Description

• Responsible for the organization, communication, and evaluation of team objectives for clinical studies.

• Engages in study design and preparation activities as necessary.

• Develops and revises documentation for clinical trials, including protocols, case report forms (CRF), and submissions to IRB/Ethics boards.

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

• Involved in or leads the evaluation and selection of potential vendors as needed.

• Conducts or oversees site visits, including pre-study, initiation, interim, and close-out visits, to ensure adherence to protocols, accurate data collection, and proper study conduct.

• Develops and updates site training resources, interprets clinical data, manages investigational sites, creates tracking tools, and engages in other clinical activities as required throughout the study.

• Leads clinical study teams to ensure clinical programs are executed in accordance with relevant regulations, guidelines, and policies.

• Manages project timelines and vendor performance to align with departmental and corporate objectives.

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

• Oversees the study budget, payment procedures, and invoice reconciliation for all clinical trial vendors, including investigative sites when relevant.

• Supervises the 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 assesses clinical data collected during research.

• Leads, prepares, and reviews project and study-related documents, which include informed consent forms, investigational brochures, case report forms, monitoring plans, synopses, protocols, amendments, and other relevant sections for studies conducted under Investigational Device Exemption (IDE) or 510(k) applications.

• Responsible for drafting internal documents and clinical study reports, as well as assisting with clinical evaluation reports.

• Develops and revises annual, interim, and final reports, along with 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 participation in the EDC and IVRS specification process and User Acceptance Testing (UAT).

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

• Responsible for the selection of 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 specific studies, as appropriate.

• Identifies and escalates site, vendor, and study-related issues to the supervisor when necessary.

• Oversees the evaluation of clinical and adverse event data throughout the study and for the completion of clinical study reports.

⛳️ Requirements

• Bachelor’s Degree or equivalent experience in a scientific discipline.

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

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

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

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

• Required knowledge and 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.

• Must possess excellent verbal and written communication skills.

• Strong attention to detail and accuracy is crucial.

🏝️ Benefits

• Retirement plans (pension).

• Savings plan (401(k)).

• Vacation – 120 hours per calendar year.

• Sick time - 40 hours per calendar year; for employees residing in Colorado – 48 hours per calendar year; for employees residing in 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 rolling 52-week period.

• Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.