The Clinical Research Associate (CRA) role focuses on supporting clinical trials, regulatory submissions, and ensuring compliance with relevant clinical regulations and industry standards. The primary responsibilities include managing study tracking tools, documentation, monitoring visits, and assisting in case of audits or inspections. This role also involves contributing to the efficient execution of clinical trials and the creation and distribution of scientific information related to Kuros Biosciences' products. Collaboration with the clinical team is essential for tasks such as ensuring compliance with protocols, reviewing clinical data, and supporting site staff.

The CRA will cover Washington, California, Utah, Illinois, Michigan and Texas and will oversee clinical research activities in these territories.

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.

• External customer focus with strong networking capabilities and integration with KOLs.

• Ability to manage multiple projects simultaneously and adapt priorities according to business and strategic needs.

• 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.).