Clinical Research Associate

Job not on LinkedIn

🕒 May 12

🐻 Alaska, Arizona, +19 more states – Remote

🐻 Alaska – Remote 🌵 Arizona – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🌺 Hawaii – Remote 🥔 Idaho – Remote 🌾 Iowa – Remote 🌪️ Kansas – Remote ⚜️ Louisiana – Remote 🦬 Montana – Remote 🌾 Nebraska – Remote 🎰 Nevada – Remote 🌶️ New Mexico – Remote 🌾 North Dakota – Remote 🌪️ Oklahoma – Remote 🌲 Oregon – Remote 🗿 South Dakota – Remote 🤠 Texas – Remote ⛷️ Utah – Remote ☕ Washington – Remote 🦬 Wyoming – Remote

💵 $65k - $75k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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A-SPINE

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2001

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

Healthcare Insurance • Pharmaceuticals • Science

A-SPINE is a leading company in Taiwan established in 2001 that specializes in the research, design, production, and sales of spinal-related medical products. The company develops and manufactures spinal implants, and also acts as an agent for well-known orthopedic medical devices from abroad. A-SPINE offers a comprehensive range of products, including spinal fixation systems, interbody fusion systems, and vertebral body replacement systems, ensuring high safety and quality standards that are highly recommended by physicians.

📋 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. 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 3-5 days per month for site visits and clinical trial support.

🎯 Requirements

• 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.).

🏖️ Benefits

• Health insurance • Flexible working hours • Professional development opportunities