In-House Clinical Research Associate, CRA
Job Description:
• Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
• Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards are met.
• Responsible for filing the site-level documents into the Trial Master Files (TMFs) in a timely manner.
• Track, review, and organize essential documents from sites and vendors.
• Identify, escalate, and help resolve site-level issues in collaboration with cross-functional teams.
• Assist with regulatory submissions and other study deliverables.
• Drive process improvements that enhance speed, quality, and patient impact.
Requirements:
• Bachelor’s degree in a life science or health-related field, or equivalent industry experience.
• 5+ years of clinical trial experience in biotech, pharma, or CRO settings.
• Solid knowledge of GCP, ICH guidelines, and regulatory requirements.
• Exceptional organizational and communication skills.
• A proactive, problem-solving mindset with high attention to detail.
• Comfortable managing multiple priorities in a fast-paced, mission-driven environment.
• Strong team player who thrives in flat, agile organizations.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Benefits:
• 99% of premium paid for medical, dental, and vision plans.
• Company-paid life insurance, AD&D, and disability benefits.
• Voluntary plans to personalize coverage.
• 401(k) matching up to 6% on eligible contributions.
• Long-term stock incentives and ESPP.
• Discretionary quarterly bonus.
• Flexible wellness benefit.
• Generous PTO and paid holidays.
• Company-wide shutdowns.
Apply Now
Apply Now
• Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
• Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards are met.
• Responsible for filing the site-level documents into the Trial Master Files (TMFs) in a timely manner.
• Track, review, and organize essential documents from sites and vendors.
• Identify, escalate, and help resolve site-level issues in collaboration with cross-functional teams.
• Assist with regulatory submissions and other study deliverables.
• Drive process improvements that enhance speed, quality, and patient impact.
Requirements:
• Bachelor’s degree in a life science or health-related field, or equivalent industry experience.
• 5+ years of clinical trial experience in biotech, pharma, or CRO settings.
• Solid knowledge of GCP, ICH guidelines, and regulatory requirements.
• Exceptional organizational and communication skills.
• A proactive, problem-solving mindset with high attention to detail.
• Comfortable managing multiple priorities in a fast-paced, mission-driven environment.
• Strong team player who thrives in flat, agile organizations.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Benefits:
• 99% of premium paid for medical, dental, and vision plans.
• Company-paid life insurance, AD&D, and disability benefits.
• Voluntary plans to personalize coverage.
• 401(k) matching up to 6% on eligible contributions.
• Long-term stock incentives and ESPP.
• Discretionary quarterly bonus.
• Flexible wellness benefit.
• Generous PTO and paid holidays.
• Company-wide shutdowns.
Apply Now
Apply Now