Clinical Research Associate - Central U.S.

Key Responsibilities

• 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. Provide support to site staff during audits or inspections.
• Ensure clinical trials are conducted in compliance with protocols, Good Clinical Practice (GCP), ICH guidelines, SOPs, and regulatory standards (FDA/DEA).
• Review and manage electronic Case Report Forms (eCRFs), ensuring data is accurate and aligned with study protocols.
• Assist in the development and maintenance of Case Report Forms (CRFs) and other study-related documents.
• Provide training to site personnel on study procedures, protocols, and regulatory requirements.
• Regularly review data entered into the Electronic Data Capture (EDC) system to ensure compliance with study protocols.
• Identify, address, and escalate any study-related risks, issues, or opportunities for improvements.
• Follow up with clinical sites to ensure that data collection is progressing as planned and all required documentation is completed.
• Ensure timely and accurate management of regulatory documents and maintain compliance with regulatory requirements.
• Engage with Key Opinion Leaders (KOLs) in the medical and research communities to stay informed on scientific research and clinical data.
• Stay up-to-date with the latest developments in scientific research and clinical data relevant to Kuros Biosciences.
• Review and track clinical trial-related invoices, ensuring accuracy and compliance.
• Contribute to the creation and maintenance of project plans for clinical trials, ensuring alignment with company policies and timelines.
• Work independently to complete tasks while ensuring alignment with team objectives, timelines, and expectations.
• Expected to travel 5-7 days per month for site visits and clinical trial support.

Qualifications

• Organized, detail-oriented, with exceptional ability to manage timelines and deadlines.
• Excellent communication and presentation creation skills.
• Teamwork skills and an ability to work effectively in a cross-functional setting with a variety of colleagues.
• Networking skills and the confidence to interact with senior experts, orthopaedic, and neurological surgeons.
• Critical data analysis skills.
• An ability to keep up to date with scientific literature.
• Skilled at scientific and clinical writing.
• A high level of emotional intelligence to work effectively with stakeholders.
• The ability to understand, process, communicate, and present scientific information to a high standard.
• An external customer focus with strong networking capabilities and integration with KOLs.
• The ability to manage multiple projects simultaneously and adapt priorities according to business and strategic needs.
• The ability to work independently without immediate supervision (if remote).

Minimum Education and/or Experience Required

• Bachelor’s Degree in a life sciences field (science-related discipline preferred).
• Minimum 3 years of medical device industry experience.
• Experience in conducting clinical trials, both as a sponsor and/or CRO, with on-site monitoring experience required.
• The highest ethical standards, specifically surrounding protected medical information and clinical research.
• Working knowledge of relevant clinical regulations and industry standards including Good Clinical Research Practice, ICH, ISO, FDA, and the MedTech EU Code of Practice.
• Excellent verbal and written communication skills (protocols, reports, correspondence, etc.).

Pay Range

$65,000 - $75,000 USD

Physical Requirements and Work Conditions

• Mobility & Posture: May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
• Lifting/Carrying: May require lifting and carrying items 50 pounds or more, depending on the role.
• Manual Dexterity: Frequent use of hands and fingers for typing, writing, grasping, and operating office or job-specific equipment.
• Driving: Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver’s license.