Clinical Research Assoc, Spain - Selution

Las Visión de Conjunto

Cordis is a pioneering medical technology company specializing in groundbreaking solutions for cardiovascular and peripheral vascular diseases. Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.

 

If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then this is the place for you.  Join us, and let’s improve the wellbeing of millions, together.

 

We are the people behind the people who keep saving lives.

 

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.

Responsabilidades

Key Accountabilities • 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 • 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

Calificaciones

• Bachelor’s degree is required • A minimum of 5 years’ experience as a clinical research associate preferred with onsite monitoring and site management activities • Required knowledge and experience monitoring medical device trials and 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 skill