Clinical Research Associate I (CRA I)

The Clinical Research Associate (CRA) is responsible for overseeing and monitoring clinical trials conducted at CND's Clinical Research Center site and investigator sites. This role ensures that studies are executed in compliance with study protocols, Good Clinical Practice (GCP) R3 guidelines, budget constraints, and established milestone timelines.

What You Will Do

Regulatory Compliance, Site Initiation, Study Monitoring, Site Communication, Site Engagement and Subject Recruitment, Site Invoices, Data Management, Safety Reporting, Site Close-Out, Trial Documentation, Team Collaboration, Reporting, Quality Assurance and Compliance

Why It Might Be a Fit

The ideal candidate will have a strong understanding of clinical trial methodologies, regulatory requirements, and the ability to collaborate effectively with investigators and internal and external cross-functional teams.

Requirements

• Minimum of 5 years of clinical research experience as a Clinical Research Coordinator or at least 2 years of experience as a Clinical Research Associate
• Therapeutic experience in neurology is highly preferred
• Experience in Phase I, II or III of clinical trials; familiarity with NIH and other government-sponsored protocols a plus
• In-depth knowledge of ICH-GCP guidelines and relevant regulatory requirements for clinical trial conduct
• Strong proficiency in IT tools including the MS 365 suite, Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) and other applicable technologies
• Excellent written and verbal communication skills
• Strong multitasking skills, attention to detail, creative problem-solving, and the ability to maintain accurate records
• Demonstrated ability to identify and resolve site-related challenges with strong negotiation skills
• Proven ability to work effectively in a team-based environment
• Willingness and ability to travel to clinical sites as needed
• Bachelor's of Science degree or related field required
• The Collaborative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) certification, or its equivalent, or willing to complete within first month of hire
• International Air Transport Association (IATA) certification, if indicated