Lead Clinical Research Associate

Job Summary

To support clinical investigations in a global medical device company, the full-time Lead Clinical Research Associate will oversee vendor CRAs, ensure compliance with monitoring activities, and mentor team members while working onsite in West Lafayette, IN with minimal travel required.

Key responsibilities

• Provide oversight of vendor CRAs and review monitoring reports to ensure quality and compliance across medical device studies
• Facilitate training and development of vendor CRAs, conducting co-monitoring visits to maintain consistency and adherence to regulations
• Collaborate with Clinical Project Managers to support monitoring strategies, resource needs, and study execution

Required qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or a related field
• At least 3 years of experience as a senior or lead Clinical Research Associate with a focus on medical device studies
• Sound knowledge of FDA regulations and GCP standards, including ISO-14155
• Proficiency in clinical trial management systems and electronic data capture systems, with experience in Veeva Vault preferred
• Demonstrated ability to mentor and influence others, along with strong communication and stakeholder management skills