Job Description

Why Join Us

We believe in taking care of our people so they can take care of others. As a global, family-owned company that has been improving patients' lives since 1963, we're committed to doing business with integrity and making a positive impact in the communities where we live and work. We're guided by strong ethical standards and core values, and we believe the best ideas come from creating solutions together. Our company culture values every voice, brings together inclusive teams who collaborate well, and encourages learning and innovation. When you join Cook, you're not just starting a job, you're building a career with purpose, in a company that invests in you.

What You Can Expect at Cook

These are some ways we support our people across Cook:
• Meaningful work & strong values: Contribute to improving patient care globally in a company known for high ethical standards and integrity.
• Competitive rewards & security: Competitive, performance-related compensation and benefits that support your health and financial wellbeing.
• Flexibility & time off: Paid time off, holidays, and hybrid or remote work options for many jobs, where possible.
• Growth & development: Learning opportunities, educational assistance, and development programs to help you grow your skills and career.
• Wellbeing & community: Health and wellness initiatives, social activities, and community engagement that help you feel connected and supported.

Benefits and programs vary by country and job. Our recruiters can provide more information about the specific benefits and programs available in your location.

Overview

We are a global medical device company conducting clinical investigations to support the development and commercialization of innovative products. We are seeking an experienced and highly motivated Senior or Lead Clinical Research Associate (CRA) ready to take the next step in their career and transition into a clinical monitoring leadership role, playing a key role in overseeing vendor CRAs and guiding monitoring operations across US-based studies.

This role is ideal for a CRA with expertise in monitoring medical device clinical studies who is passionate about mentoring others, driving quality, and shaping monitoring strategy and operations in a global, cross-functional environment.

Responsibilities

Clinical Monitoring Oversight

• Provide day-to-day oversight of vendor CRAs and monitoring activities across multiple medical device clinical studies (this position will not manage any direct reports).
• Review monitoring visit reports, follow-up letters, and monitoring metrics to ensure quality and compliance.

• Ensure monitoring activities are conducted in accordance with the monitoring plan, study protocol, company procedures, and applicable regulations.

• Evaluate monitoring effectiveness and identify opportunities for process improvements.
• and centralized monitoring activities where appropriate.
• Escalate significant site, monitoring, compliance, or data quality issues and drive resolution.

CRA Leadership, Training and Mentoring

• Maintain a strong knowledge of local and global regulations and standards (e.g., FDA, ISO-14155, EU MDR) that impact clinical studies.
• Serve as a subject matter expert for monitoring practices within the organisation.

• Facilitate onboarding, training, and ongoing development of vendor CRAs, including providing timely and constructive feedback.
• Conduct co-monitoring visits to ensure consistency, quality, and adherence to protocol, procedures, and regulatory requirements.

• Lead or contribute to training or initiatives to improve monitoring quality, consistency, and efficiency.
• Support global alignment regarding monitoring processes and sharing of best practices.

Clinical Study Management Support

• Collaborate closely with Clinical Project Managers and study teams to support monitoring strategy and study execution.
• Participate in study planning activities, including development of monitoring plans and study-specific training and monitoring tools.
• Support vendor selection and oversight activities and maintain strong relationships with CRO partners.

• Assess CRA workload and resource needs across studies to ensure adequate coverage and efficiency.
• Review site performance metrics and support risk assessments to identify sites requiring increased oversight.
• Contribute to data lock and inspection readiness activities, and support audits and regulatory inspections as needed.
• Assist in the development and maintenance of clinical procedures, work instructions, and training materials.
• Support global initiatives to drive monitoring process improvements, including adoption of remote and centralised monitoring methodologies.

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy or a related field or similar experience within science, healthcare or quality.
• Extensive experience as a CRA with a proven track record of successfully executing clinical study monitoring activities, with at least 3 years' experience as a senior or lead CRA.
• Direct experience monitoring medical device clinical studies.
• Experience with IDE studies and post-market clinical studies.
• Sound knowledge of FDA regulations and GCP standards, including ISO-14155 for medical devices.
• Proficient at utilizing clinical trial management systems and electronic data capture systems. Experience with Veeva Vault solutions is highly desirable.
• Demonstrated ability to mentor, train, and influence others.
• Excellent communication and stakeholder management skills.
• Demonstrated operational mindset with the ability to make data-informed decisions.
• Strong attention to detail, critical thinking, and independent problem-solving skills.
• Proficient working in a fast-paced environment while maintaining high attention to detail, quality, and accuracy.
• Experience implementing or supporting risk-based monitoring approaches.
• Experience participating in regulatory inspections and audits.
• Ability to travel periodically.
• This role requires founational literacy in Artificial Intelligence (AI) and data concepts, including the ability to explain these conceps simply, identify appropirate uses of AI in daily work, responsibly use approved AI tools for low-risk tasks, and consistently apply Cook Medical's data privacy and responsible AI guidelines; and
• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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