Clinical Research Associate, Medical Device

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Our client, a well-funded startup medical device company, is seeking an experienced, ambitious, and enthusiastic CRA to join their growing team. The CRA will ensure clinical studies comply with FDA regulations and ICH guidelines, and will be involved in all stages of the clinical trial process, including site identification, setup, initiation, monitoring, and closing.
Responsibilities
• Perform study start-up activities, including regulatory document collection and IRB submission approval.
• Prepare site regulatory binder.
• Ensure trials are conducted per protocol, ICH GCP, SOPs, and regulatory requirements.
• Audit the eTMF for completeness and accuracy.
• Protect subject safety and confidentiality.
• Verify data quality and completeness at study sites.
• Conduct qualification, initiation, monitoring, and close-out visits.
• Develop and maintain relationships with sites and investigators.
• Communicate effectively with the sponsor.
• Assist in the creation of study materials.
• Work independently and manage multiple projects.
Qualifications
• Bachelor’s degree in life sciences or healthcare field.
• At least 2 years of relevant experience, including on-site monitoring; advanced degrees may substitute.
• Experience in clinical trials involving medical devices.
• Clinical research certification preferred.
• Ability to travel up to 80% as needed.
• Proficiency with CTMS, EDC, eTMF, and related software.
• Strong organizational, communication, and problem-solving skills.
• Ability to work remotely with minimal supervision.
Additional Information

Benefits include medical, dental, vision, telemedicine, life insurance, accident and critical illness coverage, legal plans, and retirement options. Kelly supports a diverse and inclusive workforce and complies with all applicable laws.
Employment Details
• Seniority level: Associate
• Employment type: Full-time
• Job function: Science
• Industry: Staffing and Recruiting
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