Clinical Research Associate

Benefits

Qualifications

• •Experience implementing and managing medical device clinical trials
• •In-depth knowledge of ISO 14155, 21 CFR Part 11, 50, 54, 812, and ICH/GCP regulations
• •Proficiency in developing study documents (protocols, informed consent forms, CRFs/eCRFs, monitoring plans)
• •Experience with clinical research budgeting and contract negotiation
• •Proficiency with Microsoft Office Suite, PDF applications, and Electronic Data Capture (EDC) systems
• •Experience with Clinical Trial Management Systems (CTMS)
• •Prior experience in protocol and clinical section writing for regulatory submissions
• •Experience in medical device industry is required
• •Experience with IDE (pre-market) studies
• •Experience: 5 years required
• •7 more items(s)

Responsibilities

• •Support the successful execution of clinical studies by contributing to study design, documentation, and overall management
• •Lead and manage site start-up and activation processes, including regulatory document preparation, IRB/EC submissions, and clinical trial agreements
• •Conduct monitoring visits (qualification, initiation, interim, and close-out) and ensure protocol and regulatory compliance through source data verification and study oversight
• •Serve as the primary liaison for clinical sites, overseeing data entry, investigational device tracking, and issue resolution
• •Maintain and manage study documentation, including Trial Master File (TMF), clinical trial management systems (CTMS), and site payments
• •2 more items(s)