Senior Clinical Research Associate - Remote

Overview

T45 Labs is seeking a Senior Clinical Research Associate (CRA) to independently manage site monitoring and clinical operations activities across a range of medtech clinical trials.

In Short

• Independently perform site qualification, initiation, monitoring, and close-out visits.
• Ensure source data verification, informed consent processes, and IP accountability.
• Serve as the main point of contact for investigative sites.
• Proactively identify and address protocol deviations and data discrepancies.
• Ensure all site documentation is current and audit-ready.
• Contribute to the development and review of trial documents.
• Draft and submit monitoring visit reports.
• Collaborate with Clinical Operations leadership to meet project timelines.
• Work closely with cross-functional teams for smooth trial execution.
• Provide mentoring to junior CRAs.

Requirements

• Bachelor’s degree in Life Sciences, Nursing, or related field.
• 5+ years of clinical research experience.
• Strong knowledge of FDA, ICH-GCP, ISO 14155.
• Experience with medical device clinical trials preferred.
• Proficient in CTMS, EDC, and eTMF systems.
• Excellent interpersonal and organizational skills.
• Ability and willingness to travel up to 35%.

Benefits

• Competitive salary with bonuses and equity options.
• Comprehensive benefits package.
• Supportive team environment.
• Opportunities for professional development.
• Flexible work arrangements.