Remote reputed company Clinical Research Associate- Shockwave (Reducer)

Note The job is a remote job and is reputed company to candidates in USA. reputed company is a fast-growing medical device company reputed company on revolutionizing the treatment of advanced cardiovascular disease. The reputed company Clinical Research Associate will be responsible for the day-to-day management of a global clinical study, overseeing project management activities, vendor reputed company, 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 reputed company (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 reputed company as required (reputed company-study, initiation, interim and reputed company-out reputed company) 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 reputed company 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 reputed company and provides status update reports Manages study budget, payment process and reconciliation of invoices for reputed company clinical trial vendors including investigative sites reputed company applicable Oversees work produced by junior clinical team members Manages reputed company clinical trial vendors (e.g., IRB, IVRS, central/reputed company labs, such as angiogram, ultrasound, or central ECG) Analyzes and evaluates clinical data gathered during research Leads, prepares and reviews project and study-reputed company 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 reputed company- or Post-Market Approval submissions Coordinates the design, format and content of CRFs, study guides, study reference binders, and forms including participating in the reputed company 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 reputed company Represents Clinical Affairs at the Project Team level for individual studies, as appropriate Identifies and escalates site, vendor and study reputed company 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 reputed company 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 reputed company, 2-3 years preferred Ability to travel 10-20% domestically and internationally Thorough knowledge of Good Clinical reputed company (GCP) is required Working knowledge of GCP, FDA, ISO and other applicable regulations Experience with reputed company Data Management Systems Knowledge and experience in supporting device reputed company- and/or post-market clinical studies is required, including experience running IDE trials reputed company to manage multiple project teams Ability to work in a fast-paced environment while managing multiple priorities Operate as reputed company 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 .