Clinical Research Assoc, Spain - Selution

Cordis

Jan 27

Applications are closed

Job
Full-time
Senior Level
Healthcare
Madrid

Requirements

• 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
• 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

Responsibilities

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

FAQs

What is the main purpose of the Clinical Research Associate (CRA) role at Cordis?

The main purpose of the CRA role is to be responsible for the initiation, maintenance, and closure of trial sites, ensuring that trial data is accurate, complete, and that the trial is conducted in accordance with protocol requirements and regulatory guidelines.

What qualifications are required for this position?

A Bachelor’s degree is required, along with a minimum of 5 years of experience as a clinical research associate, preferably with onsite monitoring and site management activities.

Is prior experience with medical device trials necessary?

Yes, required knowledge and experience monitoring medical device trials, particularly in the cardiovascular space, is preferred.

How much travel is expected for this role?

Travel is required, approximately 50%, and may vary to meet trial milestones.

What competencies and skills are necessary for the CRA position?

Key competencies include being detail-oriented, strong communication skills, highly organized, critical-thinking skills, and the ability to develop relationships with stakeholders. Fluency in English is also necessary.

Will the CRA be involved in training trial site personnel?

Yes, the CRA will ensure that trial sites are trained and that the associated training documentation is available in the site’s investigator file and the sponsor trial master file.

Are there opportunities for career growth within this role?

Yes, the CRA role at Cordis can provide opportunities for career advancement through involvement in various clinical research stages and interactions with clinical leadership and cross-functional teams.

What types of clinical trials will the CRA be monitoring?

The CRA will be monitoring trials related to Cordis's flagship product, SELUTION, which focuses on coronary and peripheral artery diseases.

Will the CRA participate in audit readiness?

Yes, the CRA will support the preparation, conduct, and follow-up of BIMO audit readiness in relation to the monitoring of the IDE trials.

What is the significance of the CRA's interactions with other staff and vendors?

The CRA will have key interactions with clinical leadership, study leaders, site personnel, CROs, and outside vendors, which is crucial for ensuring successful trial execution and adherence to timelines and protocols.

Cordis

Manufacturing & Electronics

Industry

1001-5000

Employees

1959

Founded Year

Mission & Purpose

With more than a 60-year history of pioneering products to treat millions of patients, Cordis is a worldwide leader in the development and manufacturing of interventional cardiovascular technology. Cordis established a legacy of high-quality and minimally-invasive cardiovascular products; and has built a robust global footprint with operations in more than 60 countries around the world. As of August 2, 2021, Cordis is an independent company and is committed to investing $300 million to accelerate innovation and broaden its product portfolio offering. Building on our storied brand, we are unleashing our potential to be a 10X valued leader bringing new technology to the market through bold action at speed.