Lead Clinical Research Associate (CRA)​/ Clinical Monitoring Lead

What You Can Expect at 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.

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.

• 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.

• 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.

• 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.

• 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…