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Clinical Research Associate

3 weeks, 1 day ago
United States
Full-time
Mid Level
Program Manager
Project and Program Management
Apply Now
Kuros Biosciences

Kuros Biosciences

Kuros Biosciences is dedicated to discovering, developing, and delivering innovative fusion technologies to prevent non-unions in spinal surgeries. With a focus on superior biologics for spinal fusions, the company leverages over 150 years of combined ...

Pharmaceuticals
51-250
$77M raised
View All Jobs 2

Description

  • Oversee the management and tracking of clinical trial data to ensure accuracy, integrity, and completeness.
  • Conduct site qualification visits, site monitoring visits, and study close-out visits.
  • Support site staff during audits and inspections.
  • Ensure clinical trials are conducted in compliance with protocols, GCP, ICH guidelines, SOPs, and FDA/DEA regulatory standards.
  • Review and manage eCRFs and ensure study data aligns with protocol requirements.
  • Assist in the development and maintenance of CRFs and other study-related documents.
  • Provide training to site personnel on study procedures, protocols, and regulatory requirements.
  • Review data entered into the EDC system and follow up with sites to ensure timely documentation and data collection.
  • Identify, address, and escalate study-related risks, issues, and opportunities for improvement.
  • Track clinical trial invoices and contribute to project plans for clinical trial execution.

Requirements

  • Bachelor’s degree in a life sciences field; science-related discipline preferred.
  • Minimum 3 years of medical device industry experience.
  • Experience conducting clinical trials in a sponsor and/or CRO setting, with on-site monitoring experience required.
  • Working knowledge of clinical regulations and industry standards including GCP, ICH, ISO, FDA, and the MedTech EU Code of Practice.
  • Excellent verbal and written communication skills for protocols, reports, and correspondence.
  • Strong organization and detail orientation with the ability to manage timelines and deadlines.
  • Ability to work effectively in cross-functional teams and interact with senior experts and surgeons.
  • Critical data analysis skills and the ability to present scientific information clearly.
  • Ability to manage multiple projects and adapt priorities to business needs.
  • Ability to work independently without immediate supervision, especially in a remote setting.

Benefits

  • Pay range of $65,000 to $75,000 USD.
  • Opportunity to work remotely within the Central US, Mountain US, or West Coast regions.
  • Travel requirements limited to 3-5 days per month for site visits and clinical trial support.
  • Equal opportunity employer committed to diversity and inclusion.
  • Compliance with GDPR and the California Consumer Privacy Act (CCPA).

Interested in this position?

Apply directly on the company website

Apply Now

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