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 atutilizingclinical 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 whilemaintaininghigh 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
