Job Description

Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

The Clinical Research Associate (CRA) reports to the Clinical Monitoring Manager. The CRA is responsible for the initiation, maintenance and closure of trial sites. The CRA will ensure that the trial data is accurate, complete, and that the trial is conducted in accordance with protocol requirements, laboratory collections, imaging collections, regulatory requirements. The CRA will ensure relevant clinical research guidelines are adhered to and that project timelines are met. This role will interact with the clinical team, cross-functional internal teams, clinical vendors and with healthcare professionals. Clinical research is the top priority for Cordis, and this role will be directly involved in the success of the organization in improving patient care.

Key Responsibilities

• Accountable for the initiation, maintenance and closure of assigned trial sites.
• The CRA will ensure consistent support is provided to trial sites, including trial site setup and activation activities
• Verifies safety reporting, monitoring, storage of investigational devices according to study specifications, regulatory agency requirements, Cordis SOPs, ICH-GCP Guidelines, ISO 14155
• Ensures accuracy, validity, and completeness of data at trial sites in compliance with the protocol, clinical monitoring plan, informed consents forms and associated trial documents.
• Responsible for investigation of 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
• 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
• Drive 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. Escalate site issues to the study team
• Assist with resolving issues that have been identified, including actions to prevent recurrences
• Participates in study specific meetings, teleconferences and training
• 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 Clinical Research Associate

Qualifications

• A minimum of 5 years' experience as a clinical research associate preferred with onsite monitoring and site management activities
• Knowledge and experience monitoring medical device trials and cardiovascular space
• Demonstrated proficiency with computer skills (MS Office, Word, Excel and PowerPoint)
• Travel is required (Approx 65%) and may vary to meet trial milestones
• Ability to support and inspire site personnel
• Excellent interpersonal skills with the ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills

Job Tags

Full time,

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