• Accountable for the initiation, maintenance and closure of assigned trial sites
• The CRA will ensure consistent support is provided to trial sites
• Verifies safety reporting, monitoring, storage of investigational device according to study specifications, regulatory agency requirements, Cordis SOPs, ICH-GCP Guidelines, ISO 14155
• Ensure accuracy, validity, and completeness of data at trial sites in compliance with the protocol, clinical monitoring plan, informed consent forms and associated trial documents.
• Responsible for investigational device accountability/reconciliation and ensure any discrepancies, expirations or technical issues are addressed
• Ensure trial deliverables are met with efficiency and quality
• Ensure trial sites are trained and associated training documentation is available in the site’s investigator file and sponsor trial master file
• Support clinical trial site setup and activation activities
• May contribute to the development and review of the Clinical Monitoring Plan, monitoring tools, and training materials as needed
• Assist in the development of CRFs and edit checks
• Drives recruitment and retention strategies to support clinical trial enrollment/retention milestones
• Manage assigned sites to ensure monitoring metrics are met per the Clinical Monitoring Plan
• Ensuring the Trial Master File is maintained and ready for inspection
• Provide insights into trial activities, such as trends in enrollment, protocol compliance, and data quality and escalate site issues to the study team
• Assist with resolving issues that have been identified, including actions to prevent reoccurrences
• Participates in study specific meetings, teleconferences and trainings
• Ensure monitoring timelines are on track for each of the studies in relation to the PMA submission timelines
• Supports the preparation, conduct and follow-up of BIMO audit readiness in relation to monitoring of the IDE trials
• May be responsible for co-monitoring as needed
• Key interactions with clinical leadership (e.g. Monitoring Manager, Sr. Dir Clinical Operations, SVP Clinical & Regulatory), study leaders and managers, CRAs, physicians and site personnel, CROs, and outside vendors

• Bachelor’s degree is required
• A minimum of 5 years’ experience as a clinical research associate preferred with onsite monitoring and site management activities
• Experience monitoring medical device trials in the cardiovascular space
• Demonstrates proficiency with computer skills (MS Office, Word, Excel and PowerPoint)
• Travel is required (Approx 50%) May vary to meet trial milestones

Competencies & Skills

• Detail-Oriented
• Ability to support and inspire site personnel
• Strong written and oral communication skills
• Highly organized, outcome-oriented, self-motivated performance
• Supportive, keen to promote quality through example and continuous support.
• Critical-thinking and problem-solving skills
• Ability to make independent decisions
• Excellent interpersonal skills – ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
• Skill in prioritizing workflow to meet deadlines
• Fluent in English

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