Clinical Research Associate I (CRA I)

Description

Position Summary

The Clinical Research Associate (CRA) is responsible for overseeing and monitoring clinical trials conducted at CND's Clinical Research Center site and investigator sites sponsored by CND or in collaboration with external partners. This role ensures that studies are executed in compliance with study protocols, Good Clinical Practice (GCP) R3 guidelines, budget constraints, and established milestone timelines. The CRA must have a strong understanding of clinical trial methodologies, regulatory requirements, and the ability to collaborate effectively with the investigators and internal and external cross-functional teams. The CRA consistently upholds the highest standards of professionalism.

Job Responsibilities

• Regulatory Compliance: Ensure all clinical trials are conducted in adherence to the study protocol, ICH-GCP guidelines, relevant regulations and SOPs. Manage central IRB tasks for participating sites from start-up through close-out.
• CND Site Subject Visits : Assist providers with subject recruitment, scheduling and conducting site visits at the internal CND site as needed. Responsibilities may include obtaining informed consent (ICF), assessing inclusion/exclusion criteria, recording vitals, and performing blood draws as backup to CND CRC.
• Site Initiation: Conduct site initiation visits remotely or in person to assess site readiness, including regulatory start-up, facility reviews, annual bio-calibrations, supply storage, staff qualifications and training, study procedures and data entry management. Ensure all required site documents are collected and tracked in compliance with regulatory requirements and internal Standard Operating Procedures (SOPs). May also involve updating clinicaltrials.gov with site-specific information.
• Study Monitoring: Perform regular site monitoring visits remotely (via eCRF) or in person (via site source documents) per study-specific monitoring plans and timelines. Oversee data entry, protocol adherence, query resolution, quality compliance, and patient safety reporting, escalating protocol deviations or subject safety concerns as needed. Assist in the development of study-specific monitoring plans.
• Site Communication: Maintain proactive communication with site staff, responding to inquiries timely and escalating urgent matters as necessary.
• Site Engagement and Subject Recruitment: Monitoring weekly site recruitment logs to verify subject eligibility and enrollment. Assist sites with IRB approvals for advertising and recruitment strategies. Support community patient advocacy outreach when needed.
• Site Invoices: Review and approve site invoices based on completed EDC data entry and query resolution for all subject visits invoiced, including start-up and close-out visits.
• Data Management: Oversee the collection, processing, and documentation of study data. Ensure data integrity through thorough data review and timely query resolution following study-specific monitoring plan milestones.
• Safety Reporting: Oversee the reporting of adverse events and serious adverse events, ensuring compliance with regulatory requirements.
• Site Close-Out: Conduct site close-out activities to ensure proper data lock, storage, and archiving study documents.
• Trial Documentation : Maintain and manage all clinical trial documents, ensuring they remain current and compliant with regulatory standards.
• Team Collaboration: Work closely with internal and external cross-functional teams and vendors to ensure clinical trials are executed efficiently, within budget and in alignment with study milestones.
• Reporting: Provide regular updates and comprehensive reports to the Senior Director of Clinical Research and/or designated CR lead and other stakeholders on trial progress.
• Quality Assurance and Compliance Participate in internal and external audits, addressing findings, and implement corrective and preventive actions as necessary.
• Perform other duties as assigned.

Knowledge, Skills & Experience

• 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.
• Demonstratedability 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.

Education, Certifications, and Licensures

• 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

Other

• Combination of seated and standing work to complete the core functions of the role
• Sit and stand for long periods of time
• Visual acuity and analytical skills
• This job will be expected to work onsite at CND's Scottsdale, AZ headquarters 3-5 days/week