Principal Clinical Research Associate- Shockwave (Reducer)

About the role

The Principal Clinical Research Associate (CRA) is responsible for the day-to-day management of a global clinical study. The position is fully remote and can sit anywhere in the US.

Responsibilities

• Organizes, communicates, and evaluates 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.
• Led 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.
• Marks 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.
• 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.
• Covers 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.

Qualifications

• 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.
• Basic understanding of peripheral and coronary artery disease and therapies preferred.
• Knowledge and experience in supporting device pre- and/or post-market clinical studies is required, including experience running IDE trials.
• ACRP or SOCRA clinical research certification is preferred.
• Able to manage multiple project teams.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Excellent verbal and written communication skills.
• High attention to detail and accuracy.